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1.
Clin Nutr ; 43(7): 1747-1758, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38850996

ABSTRACT

BACKGROUND & AIM: Patients with an ileostomy are at increased risk of dehydration and sodium depletion. Treatments recommended may include oral rehydration solutions (ORS). We aimed to investigate if protein type or protein hydrolysation affects absorption from iso-osmolar ORS in patients with an ileostomy. METHODS: This was a randomised, double-blinded, active comparator-controlled 3 × 3 crossover intervention study. We developed three protein-based ORS with whey protein isolate, caseinate or whey protein hydrolysate. The solutions contained 40-48 g protein/L, 34-45 mmol sodium/L and had an osmolality of 248-270 mOsm/kg. The patients ingested 500 mL/d. The study consisted of three 4-week periods with a >2-week washout between each intervention. The primary outcome was wet-weight ileostomy output. Ileostomy output and urine were collected for a 24-h period before and after each intervention. Additionally, blood sampling, dietary records, muscle-strength tests, bioimpedance analyses, questionnaires and psychometric tests were conducted. RESULTS: We included 14 patients, of whom 13 completed at least one intervention. Ten patients completed all three interventions. Wet-weight ileostomy output did not change following either of the three interventions and did not differ between interventions (p = 0.38). A cluster of statistically significant improvements related to absorption was observed following the intake of whey protein isolate ORS, including decreased faecal losses of energy (-365 kJ/d, 95% confidence interval (CI), -643 to -87, p = 0.012), potassium (-7.8 mmol/L, 95%CI, -12.0 to -3.6, p = 0.001), magnesium (-4.0 mmol/L, 95%CI, -7.4 to -0.7, p = 0.020), improved plasma aldosterone (-4674 pmol/L 95%CI, -8536 to -812, p = 0.019), estimated glomerular filtration rate (eGFR) (2.8 mL/min/1.73 m2, 95%CI, 0.3 to 5.4, p = 0.03) and CO2 (1.7 mmol/L 95%CI, 0.1 to 3.3, p = 0.04). CONCLUSION: Ingestion of 500 mL/d of iso-osmolar solutions containing either whey protein isolate, caseinate or whey protein hydrolysate for four weeks resulted in unchanged and comparable ileostomy outputs in patients with an ileostomy. Following whey protein isolate ORS, we observed discrete improvements in a series of absorption proxies in both faeces and blood, indicating increased absorption. The protein-based ORS were safe and well-tolerated. Treatments should be tailored to each patient, and future studies are warranted to explore treatment-effect heterogeneity and whether different compositions or doses of ORS can improve absorption and nutritional status in patients with an ileostomy. GOV STUDY IDENTIFIER: NCT04141826.


Subject(s)
Cross-Over Studies , Fluid Therapy , Ileostomy , Rehydration Solutions , Whey Proteins , Humans , Double-Blind Method , Male , Female , Whey Proteins/administration & dosage , Middle Aged , Aged , Rehydration Solutions/administration & dosage , Fluid Therapy/methods , Dehydration/therapy , Caseins/administration & dosage , Protein Hydrolysates/administration & dosage , Adult
3.
Eur Geriatr Med ; 14(3): 583-593, 2023 06.
Article in English | MEDLINE | ID: mdl-37046032

ABSTRACT

PURPOSE: Clostridioides difficile infection (CDI) has a high mortality among older patients. Identification of older patients with CDI in increased mortality risk is important to target treatment and thereby reduce mortality. The aim of this study was to investigate mortality rates and compare frailty levels at discharge, measured by the record-based Multidimensional Prognostic Index (MPI), with age and severity of CDI as mortality predictors in patients with CDI diagnosed during hospitalisation. METHODS: This was a population-based cohort study from Central Denmark Region, Denmark, including all patients ≥ 60 years with a positive CD toxin test without prior infection and diagnosed from 1 January to 31 December 2018. Frailty level, estimated from the electronic medical record, was defined as low, moderate, or severe frailty. CDI severity was graded according to international guidelines. Primary outcome was 90-day mortality. RESULTS: We included 457 patients with median age 77 years (interquartile range 69-84) and females (49%). Overall, 90-day mortality was 28%, and this was associated with age (hazard ratio (HR): 2.71 (95% confidence interval 1.64-4.47)), CDI severity (HR 4.58 (3.04-6.88)) and frailty (HR 10.15 (4.06-25.36)). Frailty was a better predictor of 90-day mortality than both age (p < 0.001) and CDI severity (p = 0.04) with a receiver operating characteristic curve area of 77%. CONCLUSION: The 90-day mortality among older patients with CDI in a Danish region is 28%. Frailty measured by record-based MPI at discharge outperforms age and disease severity markers in predicting mortality in older patients with CDI.


Subject(s)
Clostridioides difficile , Clostridium Infections , Frailty , Female , Humans , Aged , Clostridioides , Cohort Studies , Patient Discharge , Risk Factors , Clostridium Infections/diagnosis , Patient Acuity
4.
J Autoimmun ; 141: 103036, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37098448

ABSTRACT

Fecal microbiota transplantation (FMT) is known to be highly effective in patients with recurrent Clostridioides difficile infection (rCDI), but its role in patients who also suffer from inflammatory bowel disease (IBD) is unclear. Therefore, we performed a systematic review and meta-analysis to evaluate the efficacy and safety of FMT for the treatment of rCDI in patients with IBD. We searched the available literature until November 22, 2022 to identify studies that included patients with IBD treated with FMT for rCDI, reporting efficacy outcomes after at least 8 weeks of follow-up. The proportional effect of FMT was summarized with a generalized linear mixed-effect model fitting a logistic regression accounting for different intercepts among studies. We identified 15 eligible studies, containing 777 patients. Overall, FMT achieved high cure rates of rCDI, 81% for single FMT, based on all included studies and patients, and 92% for overall FMT, based on nine studies with 354 patients, respectively. We found a significant advantage of overall FMT over single FMT in improving cure rates of rCDI (from 80% to 92%, p = 0.0015). Serious adverse events were observed in 91 patients (12% of the overall population), with the most common being hospitalisation, IBD-related surgery, or IBD flare. In conclusion, in our meta-analysis FMT achieved high cure rates of rCDI in patients with IBD, with a significant advantage of overall FMT over single FMT, similar to data observed in patients without IBD. Our findings support the use of FMT as a treatment for rCDI in patients with IBD.


Subject(s)
Clostridioides difficile , Clostridium Infections , Inflammatory Bowel Diseases , Humans , Fecal Microbiota Transplantation/adverse effects , Treatment Outcome , Recurrence , Inflammatory Bowel Diseases/therapy , Inflammatory Bowel Diseases/etiology , Clostridium Infections/therapy , Clostridium Infections/etiology
5.
Clin Microbiol Infect ; 29(6): 799.e1-799.e4, 2023 Jun.
Article in English | MEDLINE | ID: mdl-36805882

ABSTRACT

OBJECTIVES: The aim was to determine if Helicobacter pylori is transmitted from donors to recipients by faecal microbiota transplantation (FMT) via oral capsules. METHODS: In a cohort of faeces donors not primarily screened for H. pylori, consecutive stool samples were retrospectively analysed by the H. pylori stool antigen test (SAT). Subsequently, we analysed recipient stool samples collected before and after receiving faeces donated by H. pylori SAT-positive donors, and we recorded recipient use of antibiotics and proton pump inhibitors. All stool samples were frozen upon collection and stored at -80°C until use. RESULTS: Thirteen out of 40 faeces donors (33%; 95% CI, 20-48%) were H. pylori SAT-positive. Among those positive, five donors donated faeces for 28 capsule-based FMTs performed in 26 recipients with stool samples collected before and after FMT. At a median of 59 days (range, 7-84 days) after FMT, no recipients (0%; 95% CI, 0-11%) were H. pylori SAT-positive. DISCUSSION: We found no occurrence of H. pylori transmission from healthy, asymptomatic donors to recipients by oral capsule-based FMT, although with a wide CI.


Subject(s)
Fecal Microbiota Transplantation , Helicobacter pylori , Humans , Retrospective Studies , Feces/microbiology , Tissue Donors
7.
Gut Microbes ; 14(1): 2084306, 2022.
Article in English | MEDLINE | ID: mdl-36519447

ABSTRACT

AbstarctIn fecal microbiota transplantation (FMT) against recurrent Clostridioides difficile infection (CDI), clinical outcomes are usually determined after 8 weeks. We hypothesized that the intestinal microbiota changes earlier than this timepoint, and analyzed fecal samples obtained 1 week after treatment from 64 patients diagnosed with recurrent CDI and included in a randomized clinical trial, where the infection was treated with either vancomycin-preceded FMT (N = 24), vancomycin (N = 16) or fidaxomicin (N = 24). In comparison with non-responders, patients with sustained resolution after FMT had increased microbial alpha diversity, enrichment of Ruminococcaceae and Lachnospiraceae, depletion of Enterobacteriaceae, more pronounced donor microbiota engraftment, and resolution of gut microbiota dysbiosis. We found that a constructed index, based on markers for the identified genera Escherichia and Blautia, successfully predicted clinical outcomes at Week 8, which exemplifies a way to utilize clinically feasible methods to predict treatment failure. Microbiota changes were restricted to patients who received FMT rather than antibiotic monotherapy, indicating that FMT confers treatment response in a different way than antibiotics. We suggest that early identification of microbial community structures after FMT is of clinical value to predict response to the treatment.


Subject(s)
Clostridioides difficile , Clostridium Infections , Gastrointestinal Microbiome , Humans , Fecal Microbiota Transplantation/methods , Clostridioides difficile/physiology , Vancomycin/therapeutic use , Clostridium Infections/therapy , Treatment Outcome , Anti-Bacterial Agents/therapeutic use
8.
Microbiome ; 10(1): 193, 2022 11 10.
Article in English | MEDLINE | ID: mdl-36352460

ABSTRACT

BACKGROUND: Fecal microbiota transplantation (FMT) effectively prevents the recurrence of Clostridioides difficile infection (CDI). Long-term engraftment of donor-specific microbial consortia may occur in the recipient, but potential further transfer to other sites, including the vertical transmission of donor-specific strains to future generations, has not been investigated. Here, we report, for the first time, the cross-generational transmission of specific bacterial strains from an FMT donor to a pregnant patient with CDI and further to her child, born at term, 26 weeks after the FMT treatment. METHODS: A pregnant woman (gestation week 12 + 5) with CDI was treated with FMT via colonoscopy. She gave vaginal birth at term to a healthy baby. Fecal samples were collected from the feces donor, the mother (before FMT, and 1, 8, 15, 22, 26, and 50 weeks after FMT), and the infant (meconium at birth and 3 and 6 months after birth). Fecal samples were profiled by deep metagenomic sequencing for strain-level analysis. The microbial transfer was monitored using single nucleotide variants in metagenomes and further compared to a collection of metagenomic samples from 651 healthy infants and 58 healthy adults. RESULTS: The single FMT procedure led to an uneventful and sustained clinical resolution in the patient, who experienced no further CDI-related symptoms up to 50 weeks after treatment. The gut microbiota of the patient with CDI differed considerably from the healthy donor and was characterized as low in alpha diversity and enriched for several potential pathogens. The FMT successfully normalized the patient's gut microbiota, likely by donor microbiota transfer and engraftment. Importantly, our analysis revealed that some specific strains were transferred from the donor to the patient and then further to the infant, thus demonstrating cross-generational microbial transfer. CONCLUSIONS: The evidence for cross-generational strain transfer following FMT provides novel insights into the dynamics and engraftment of bacterial strains from healthy donors. The data suggests FMT treatment of pregnant women as a potential strategy to introduce beneficial strains or even bacterial consortia to infants, i.e., neonatal seeding. Video Abstract.


Subject(s)
Clostridioides difficile , Clostridium Infections , Adult , Female , Humans , Infant, Newborn , Pregnancy , Bacteria , Clostridium Infections/therapy , Clostridium Infections/microbiology , Fecal Microbiota Transplantation/methods , Feces/microbiology , Recurrence , Treatment Outcome
9.
Lancet Gastroenterol Hepatol ; 7(12): 1083-1091, 2022 12.
Article in English | MEDLINE | ID: mdl-36152636

ABSTRACT

BACKGROUND: Clostridioides difficile infection is an urgent antibiotic-associated health threat with few treatment options. Microbiota restoration with faecal microbiota transplantation is an effective treatment option for patients with multiple recurring episodes of C difficile. We compared the efficacy and safety of faecal microbiota transplantation compared with placebo after vancomycin for first or second C difficile infection. METHODS: We did a randomised, double-blind, placebo-controlled trial (EarlyFMT) at a university hospital in Aarhus, Denmark. Eligible patients were aged 18 years or older with first or second C difficile infection (defined as ≥3 watery stools [Bristol stool chart score 6-7] per day and a positive C difficile PCR test). Patients were randomly assigned (1:1) to faecal microbiota transplantation or placebo administered on day 1 and between day 3 and 7, after they had received 125 mg oral vancomycin four times daily for 10 days. Randomisation was done by investigators using a computer-generated randomisation list provided by independent staff. Patients and investigators were masked to the treatment group. The primary endpoint was resolution of C difficile-associated diarrhoea (CDAD) 8 weeks after treatment. We followed up patients for 8 weeks or until recurrence. We planned to enrol 84 patients with a prespecified interim analysis after 42 patients. The primary outcome and safety outcomes were analysed in the intention-to-treat population, which included all randomly assigned patients. The trial is registered with ClinicalTrials.gov, NCT04885946. FINDINGS: Between June 21, 2021, and April 1, 2022, we consecutively screened 86 patients, of whom 42 were randomly assigned to faecal microbiota transplantation (n=21) or placebo (n=21). The trial was stopped after the interim analysis done on April 7, 2022 for ethical reasons because a significantly lower rate of resolution was identified in the placebo group compared with the faecal microbiota transplantation group (Haybittle-Peto boundary limit p<0·001). 19 (90%; 95% CI 70-99) of 21 patients in the faecal microbiota transplantation group and seven (33%, 95% CI 15-57) of 21 patients in the placebo group had resolution of CDAD at week 8 (p=0·0003). The absolute risk reduction was 57% (95% CI 33-81). Overall, 204 adverse events occurred, with one or more adverse events being reported in 20 of 21 patients in the faecal microbiota transplantation group and all 21 patients in the placebo group. Diarrhoea (n=23 in the faecal microbiota transplantation group; n=14 in the placebo group) and abdominal pain (n=14 in the faecal microbiota transplantation group; n=11 in the placebo group) were the most common adverse events. Three serious adverse events possibly related to study treatment occurred (n=1 in the faecal microbiota transplantation group; n=2 in the placebo group), but no deaths or colectomies during the 8-week follow-up. INTERPRETATION: In patients with first or second C difficile infection, first-line faecal microbiota transplantation is highly effective and superior to the standard of care vancomycin alone in achieving sustained resolution from C difficile. FUNDING: Innovation Fund Denmark.


Subject(s)
Clostridium Infections , Fecal Microbiota Transplantation , Humans , Fecal Microbiota Transplantation/adverse effects , Vancomycin/therapeutic use , Clostridium Infections/therapy , Diarrhea/therapy , Diarrhea/drug therapy , Double-Blind Method
12.
Lancet Reg Health Eur ; 9: 100181, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34693388

ABSTRACT

BACKGROUND: Faecal microbiota transplantation (FMT) is an emerging treatment modality, but its current clinical use and organisation are unknown. We aimed to describe the clinical use, conduct, and potential for FMT in Europe. METHODS: We invited all hospital-based FMT centres within the European Council member states to answer a web-based questionnaire covering their clinical activities, organisation, and regulation of FMT in 2019. Responders were identified from trials registered at clinicaltrials.gov and from the United European Gastroenterology (UEG) working group for stool banking and FMT. FINDINGS: In 2019, 31 FMT centres from 17 countries reported a total of 1,874 (median 25, quartile 10-64) FMT procedures; 1,077 (57%) with Clostridioides difficile infection (CDI) as indication, 791 (42%) with experimental indications, and 6 (0•3%) unaccounted for. Adjusted to population size, 0•257 per 100,000 population received FMT for CDI and 0•189 per 100,000 population for experimental indications. With estimated 12,400 (6,100-28,500) annual cases of multiple, recurrent CDI and indication for FMT in Europe, the current European FMT activity covers approximately 10% of the patients with indication. The participating centres demonstrated high safety standards and adherence to international consensus guidelines. Formal or informal regulation from health authorities was present at 21 (68%) centres. INTERPRETATION: FMT is a widespread routine treatment for multiple, recurrent CDI and an experimental treatment. Embedded within hospital settings, FMT centres operate with high standards across Europe to provide safe FMT. A significant gap in FMT coverage suggests the need to raise clinical awareness and increase the FMT activity in Europe by at least 10-fold to meet the true, indicated need. FUNDING: NordForsk under the Nordic Council and Innovation Fund Denmark (j.no. 8056-00006B).

13.
Therap Adv Gastroenterol ; 14: 17562848211041004, 2021.
Article in English | MEDLINE | ID: mdl-34484424

ABSTRACT

BACKGROUND: Faecal microbiota transplantation (FMT) is an effective treatment of recurrent Clostridioides difficile infection (rCDI) and is being applied experimentally in other diseases. Encapsulated administration may be equivalent in efficacy to delivery through other routes. METHODS: A systematic review was undertaken of studies using encapsulated FMT up to 26 October 2020. Data on indication, clinical outcomes, safety, treatment protocol and capsule preparation were collected and reported. Pooled rates of clinical efficacy in rCDI were calculated using random-effects meta-analysis. The impact of single variables on clinical efficacy was evaluated using univariate meta-regression. RESULTS: A total of 35 studies reporting the treatment of 960 patients with encapsulated FMT for eight different indications met the inclusion criteria. Most studies (n = 18, 51%) and patients (n = 755, 79%) were from studies on rCDI. Cure rates after single and multiple courses of treatments with encapsulated FMT in rCDI were 85% (95% CI: 82%-88%) and 93% (95% CI: 88%-96%) respectively. The treatment outcome was not significantly affected by dose, number of delivered capsules, anaerobic/aerobic processing, single/multi-donor treatment, lyophilisation, or any other single factor in the production or delivery of encapsulated FMT. Promising but non-comparable results from the treatment of ulcerative colitis and multidrug-resistant organisms were reported. CONCLUSIONS: Encapsulated FMT is an effective and safe treatment of rCDI, with cure rates comparable to FMT delivered through other routes. The treatment is effective despite variations in donor screening, preparation and treatment protocol. For other indications, the role of FMT capsules is still not sufficiently examined, although some studies show promising results. PLAIN LANGUAGE SUMMARY: Transfer of faecal material through capsules in the treatment of various diseases. Evidence for clinical efficacy The bacteria and other microorganisms of the gut is different in patient with various diseases in comparison with healthy subjects.Therefore, ways to change the microorganisms of the gut in a beneficial direction has been the subject of various research projects within recent years.Faecal microbiota transplantation often referred as FMT is a method of transferring microorganisms from healthy donors to patients with various diseases and is seen as one way to change the microbial community of the gut in a beneficial direction.Faecal microbiota transplantation can be performed in different ways such as through endoscopy, enemas or capsules. The transfer through capsules is preferred by the patients and has advantages since it can be administered long-term and can be delivered to the patients in their home. In this paper, we evaluated all accessible research reporting treatment with encapsulated faecal microbiota transplantation in the treatment of various diseases. We report the following major findings:-Treatment with capsules is safe when guidelines for screening donors and testing faecal material is followed.-The treatment is highly effective in the treatment of recurrent C. difficile infection, a disease with high mortality often caused by repeated antibiotic treatments. The treatment was effective in 596 of 723 patients following one course of capsule treatment.-Faecal microbiota transplantation delivered through capsules is as effective as treatment delivered through other routes in the treatment of C. difficile infection.-The treatment is effective in the treatment of C. difficile infection across studies and countries, despite great differences in the ways the capsules were prepared and delivered.-Increasing the amount of faecal material used in the production did not affect the efficacy of the treatment.-There are promising results in the treatment of other diseases such as liver disease, inflammatory bowel disease and the treatment of multi-drug resistant bacteria.

14.
Scand J Gastroenterol ; 56(9): 1056-1077, 2021 09.
Article in English | MEDLINE | ID: mdl-34261379

ABSTRACT

Aim: This Danish national guideline describes the treatment of adult patients with Clostridioides (formerly Clostridium) difficile (CD) infection and the use of faecal microbiota transplantation (FMT). It suggests minimum standard for implementing an FMT service.Method: Four scientific societies appointed members for a working group which conducted a systematic literature review and agreed on the text and recommendations. All clinical recommendations were evalluated for evidence level and grade of recommendation.Results: In CD infection, the use of marketed and experimental antibiotics as well as microbiota-based therapies including FMT are described. An algorithm for evaluating treatment effect is suggested. The organisation of FMT, donor recruitment and screening, laboratory preparation, clinical application and follow-up are described.Conclusion: Updated evidence for the treatment of CD infection and the use of FMT is provided.


Subject(s)
Clostridioides difficile , Clostridium Infections , Adult , Clostridioides , Clostridium Infections/therapy , Denmark , Fecal Microbiota Transplantation , Humans
15.
Aliment Pharmacol Ther ; 54(5): 560-570, 2021 09.
Article in English | MEDLINE | ID: mdl-34275167

ABSTRACT

BACKGROUND: Nutrition support teams (NST) may improve parenteral nutrition (PN) outcomes. No previous systematic review has provided conclusive data on catheter-related infection (CRI) occurrence after NST introduction, nor have previous studies performed meta-analysis or graded the evidence. AIMS: To systematically evaluate the effects of implementing an NST for hospitalised adults on PN and compare these with standard care. METHODS: This was a systematic review and meta-analysis, pre-registered in PROSPERO (CRD42020218094). On November 24, 2020, PubMed, Web of science, Scopus, Embase, Cochrane Library, and Clinical Key were searched. Clinical trials and observational studies with a standard care comparator were included. Primary outcome was relative reduction in CRI rate. A random-effects meta-analysis was used to estimate effects, and evidence was rated using Cochrane and GRADE methodologies. RESULTS: Twenty-seven studies with 8166 patients were included. Across 10 studies, NST introduction reduced the CRI rate (IRR = 0.32, 95% CI: 0.19-0.53) with -8 (95% CI: -12 to -5) episodes per 1000 catheter days compared with standard care. Hypophosphataemia occurred less frequently (IRD = -12%, 95% CI: -24% to -1%) and 30-day mortality decreased (IRD = -6%, 95% CI: -11% to -1%). Inappropriate PN use decreased, both judged by indication (IRD = -18%, 95% CI: -28% to -9%) and duration (IRD = -21%, 95% CI: -33% to -9%). Evidence was rated very low to moderate. CONCLUSIONS: This study documents the clinical impact of introducing an NST, with moderate-grade evidence for the reduction of CRI occurrence compared with standard care. Further, NST introduction significantly reduced metabolic complications, mortality, and inappropriate PN use.


Subject(s)
Hospitals , Parenteral Nutrition , Adult , Humans
16.
Appl Environ Microbiol ; 87(11)2021 05 11.
Article in English | MEDLINE | ID: mdl-33741632

ABSTRACT

Assessing "dysbiosis" in intestinal microbial communities is increasingly considered a routine analysis in microbiota studies, and it has added relevant information to the prediction and characterization of diseases and other adverse conditions. However, dysbiosis is not a well-defined condition. A variety of different dysbiosis indexes have been suggested and applied, but their underlying methodologies, as well as the cohorts and conditions for which they have been developed, differ considerably. To date, no comprehensive overview and comparison of all the different methodologies and applications of such indexes is available. Here, we list all types of dysbiosis indexes identified in the literature, introduce their methodology, group them into categories, and discuss their potential descriptive and clinical applications as well as their limitations. Thus, our focus is not on the implications of dysbiosis for disease but on the methodological approaches available to determine and quantify this condition.


Subject(s)
Diagnostic Tests, Routine/methods , Dysbiosis/diagnosis , Gastrointestinal Microbiome/physiology , Dysbiosis/microbiology , Humans
18.
Health Econ Rev ; 11(1): 3, 2021 Jan 13.
Article in English | MEDLINE | ID: mdl-33439367

ABSTRACT

BACKGROUND: Faecal microbiota transplantation (FMT) is increasingly being used in the treatment of recurrent Clostridioides difficile infection (rCDI). Health economic evaluations may support decision-making regarding the implementation of FMT in clinical practice. Previous reviews have highlighted several methodological concerns in published health economic evaluations examining FMT. However, the impact of these concerns on the conclusions of the studies remains unclear. AIMS: To present an overview and assess the methodological quality of health economic evaluations that compare FMT with antibiotics for treatment of rCDI. Furthermore, we aimed to evaluate the degree to which any methodological concerns would affect conclusions about the cost-effectiveness of FMT. METHODS: We conducted a systematic literature review based on a search in seven medical databases up to 16 July 2020. We included research articles reporting on full health economic evaluations comparing FMT with antibiotic treatment for rCDI. General study characteristics and input estimates for costs, effectiveness and utilities were extracted from the articles. The quality of the studies was assessed by two authors using the Drummonds ten-point checklist. RESULTS: We identified seven cost-utility analyses. All studies applied decision-analytic modelling and compared various FMT delivery methods with vancomycin, fidaxomicin, metronidazole or a combination of vancomycin and bezlotoxumab. The time horizons used in the analyses varied from 78 days to lifelong, and the perspectives differed between a societal, a healthcare system or a third-party payer perspective. The applied willingness-to-pay threshold ranged from 20,000 to 68,000 Great Britain pound sterling (GBP) per quality-adjusted life-year (QALY). FMT was considered the most cost-effective alternative in all studies. In five of the health economic evaluations, FMT was both more effective and cost saving than antibiotic treatment alternatives. The quality of the articles varied, and we identified several methodological concerns. CONCLUSIONS: Economic evaluations consistently reported that FMT is a cost-effective and potentially cost-saving treatment for rCDI. Based on a comparison with recent evidence within the area, the multiple methodological concerns seem not to change this conclusion. Therefore, implementing FMT for rCDI in clinical practice should be strongly considered.

19.
J Clin Med ; 10(2)2021 Jan 12.
Article in English | MEDLINE | ID: mdl-33445668

ABSTRACT

BACKGROUND: Most patients with a spinal cord injury (SCI) suffer from neurogenic bowel dysfunction (NBD). In spite of well-established treatment algorithms, NBD is often insufficiently managed. The Monitoring Efficacy of Neurogenic bowel dysfunction Treatment On Response (MENTOR) has been validated in a hospital setting as a tool to support clinical decision making in individual patients. The objective of the present study was to describe clinical decisions recommended by the MENTOR (either "monitor", "discuss" or "act") and the use of the tool to monitor NBD in a non-hospital setting. METHODS: A questionnaire describing background data, the MENTOR, ability to work and participation in various social activities was sent by mail to all members of The Danish Paraplegic Association. RESULTS: Among 1316 members, 716 (54%) responded, 429 men (61%) and 278 women (39%), aged 18 to 92 (median 61) years. Based on MENTOR, the recommended clinical decision is to monitor treatment of NBD in 281 (44%), discuss change in treatment in 175 (27%) and act/change treatment in 181 (28%). A recommendation to discuss or change treatment was associated with increasing age of the respondent (p = 0.016) and with impaired ability to work or participate in social activities (p < 0.0001). CONCLUSION: A surprisingly high proportion of persons with SCI have an unmet need for improved bowel care. The MENTOR holds promise as a tool for evaluation of treatment of NBD in a non-hospital setting.

20.
JPEN J Parenter Enteral Nutr ; 45(6): 1259-1267, 2021 08.
Article in English | MEDLINE | ID: mdl-32841404

ABSTRACT

BACKGROUND: Patients with intestinal failure (IF) are prone to hypophosphatemia and shifts in magnesium and potassium levels. Although these shifts are often attributed to refeeding syndrome (RFS), the incidence of electrolyte shifts among patients with IF is unknown. We evaluated the occurrence of hypophosphatemia and other electrolyte shifts according to the functional and pathophysiological IF classifications. METHODS: We consecutively included all patients' first admission to an IF unit from 2013 to 2017. Electrolyte shifts were defined as severe hypophosphatemia <0.6 mmol/L (mM) or any 2 other shifts below reference range, comprising hypomagnesemia <0.75 mM, hypophosphatemia <0.8 mM, or hypokalemia <3.5 mM. Outcomes included length of stay, central line-associated bloodstream infection, and other infections. Mortality was evaluated 6 months after discharge. RESULTS: Of 236 patients with IF, electrolyte shifts occurred in 99 (42%), and 127 (54%) of these patients received intravenous supplementation with either phosphate, magnesium, or potassium. In patients who started parenteral nutrition, up to 62% of early-onset shifts (<5 days) related to refeeding, and up to 63% of late-onset shifts (≥5 days) could be ascribed to infections. Derangements occurred in 7 (18%) with type 1 IF, 53 (43%) with type 2 IF, and 39 (53%) readmitted patients with type 3 IF. Of 133 patients with IF secondary to short-bowel syndrome, 65 (49%) developed shifts. CONCLUSION: In patients with IF, electrolyte shifts are frequent but not always due to RFS. Electrolyte shifts are common in patients with type 2 and those readmitted with type 3 IF.


Subject(s)
Hypokalemia , Hypophosphatemia , Refeeding Syndrome , Cohort Studies , Humans , Hypophosphatemia/epidemiology , Hypophosphatemia/etiology , Parenteral Nutrition/adverse effects , Refeeding Syndrome/etiology
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