Translation process of the tested Rome IV diagnostic questionnaire for functional gastrointestinal disorders into Saudi-Arabian Arabic: A mixed-methods approach.

Objective: A report on the cross-cultural adaptation and validation process of the Rome IV Diagnostic Questionnaire for children aged four years and over into Saudi-Arabian Arabic for use in assessing the prevalence of functional gastrointestinal disorders in children in Saudi Arabia. Method: A mixed-methods approach was used in translating the 60-item original English version of the questionnaire. The process included four steps followed by a cognitive debriefing and was guided by the Rome Foundation. The questionnaire was tested for practicability with 10 participants of children aged four years and older. The whole study took place between October 2020 and April 2021. Results: The original questionnaire repeated information on areas of pain experienced by children, which did not show up in the backward, English, translation. The back-translated version occasionally provided medical expressions that were then explained between parentheses in plain English, for example, dyspepsia (burning feeling). The expert panel indicated that all questionnaire items reached the set 90% agreement level, confirming that the questionnaire is fully understandable and valid for use. Preliminary testing with 10 participants (four years and older) revealed functional constipation to have the highest prevalence among the participants (40%, n=4), followed by irritable bowel syndrome (20%) and abdominal migraine (20%). Conclusion: This study provides a detailed report on the translation process of the tested ROME- IV Diagnostic Questionnaire for children aged four years and over into Saudi Arabic following Rome Foundation guidelines. The results of the preliminary test should encourage researchers and clinicians in Saudi Arabia to utilize the tool for non-invasive diagnosis of functional gastrointestinal disorders in children.

The impact of Ramadan during COVID-19 confinement on weight, dietary, and lifestyle habits in the Kingdom of Saudi Arabia: a cross-sectional study.

Severe procedures were undertaken globally because of the COVID-19 pandemic to overcome the spread of the disease and to prevent catastrophic results affecting the health care system including social distancing, lockdowns, and quarantines. Despite the widely known health benefits of Ramadan fasting, there was a general concern regarding the lifestyle of people during Ramadan 2020 that accompanied the period of COVID-19 pandemic and the home confinement applied. The main objective for the current cross-sectional investigation was to investigate the influence of Covid-19 lockdown during Ramadan fasting on weight change on 481 participants in Saudi Arabia. Identifying the contributing risk factors to weight gain were also addressed. Around 42% of the participants had gained weight and around 38% of the participants had lost weight. Physical activity level was shown to be considered as a protective factor against weight gain (OR = 1.03 with P = 0.008), while increasing the number of meals and not adapting healthy cooking methods can both be considered as contributing factors to weight gain (OR = 1.03 with P = 0.009, and OR = 1.03 with P = 0.004, respectively). Assessing these changes during Ramadan of COVID-19 quarantine provided valuable perspective on the health and wellbeing of Saudi Arabia citizens. These findings should be considered in future studies to explore the persistence of Covid-19 related weight status and habit change.

Exploring the Prevalence of Functional Gastrointestinal Diseases and the Accompanied Differences in Dietary and Lifestyle Patterns: A Two-Generational Study.

BACKGROUND AND OBJECTIVES: Generation Z and millennials in Saudi Arabia both experienced the stress of the COVID-19 pandemic and the accompanying factors that may have had an impact on the incidence of functional gastrointestinal diseases (FGIDs) in both generations. This study aims to explore how prevalent FGIDs are among adolescents and their parents. METHODS AND STUDY DESIGN: A cross-sectional, school-based study conducted in public high schools for boys and girls in Jeddah, Saudi Arabia. We adapted 37 items from the ROME IV Diagnostic Questionnaires for children and adults, as well as other questionnaires. IBM SPSS Statistics (Version 28.0) was used. RESULTS: Generation Z showed a higher prevalence of FGIDs (33.5%, n = 126) in comparison with millennials (20.0%, n = 28). In both generations, the most prevalent FGID was functional constipation; the least prevalent were irritable bowel syndrome and abdominal migraine, with no significant change in the severity or frequency of symptoms during the pandemic. The type of commonly consumed beverages was a risk factor for FGIDs. Participants in generation Z were less likely to use complementary and alternative medicine (67.4%) to prevent diseases and enhance immunity compared with millennials (82.9%). CONCLUSIONS: The study results confirmed disparities in the prevalence of FGIDs between the two generations before and during the COVID-19 pandemic, which requires further research in other areas of Saudi Arabia. Recognizing the differences between the millennial parents and the generation Z high schoolers could assist health professionals in planning individualized, generation-based interventions and educators in designing and tailoring programs based on generational differences.

The risk of low energy availability among athlete females in Saudi Arabia: a cross-sectional study.

Introduction: Low energy availability (LEA) is a state of inadequate energy reserves that results from a negative energy balance. This condition can lead to severe health risks such as amenorrhea and osteoporosis. Various causes for LEA, such as eating disorders and exercise addiction, have been reported in the literature. However, data in Saudi Arabia are lacking. This cross-sectional study measures the prevalence of LEA, eating disorders, and exercise addiction among adult females in Saudi Arabia and identifies possible associated risk factors. Methods: The sample comprised 119 female athletes who filled out an online survey adapted from the LEA in Females Questionnaire, the Eating Disorder Examination Questionnaire, and the Exercise Addiction Inventory. Results: Participants showed a high prevalence of LEA (66.4%), eating disorder (33.6%), and exercise addiction (10.1%), confirming the association between normal weight and LEA in females living in Saudi Arabia (p < 0.00). Discussion and conclusion: With an increasing number of females in the country interested in following a healthy lifestyle, there is a need to raise the awareness of the population on the issues of LEA, eating disorders, and exercise addiction and their effects on the body by developing educational programs about energy intake and healthy physical activity routines.

Low Emulsifier Diet in Healthy Female Adults: A Feasibility Study of Nutrition Education and Counseling Intervention.

Emulsifiers are food additives commonly found in processed foods to improve texture stabilization and food preservation. Dietary emulsifier intake can potentially damage the gut mucosal lining resulting in chronic inflammation such as Crohn's disease. This study investigates the feasibility of a low-emulsifier diet among healthy female adults, as no previous reports have studied the feasibility of such a diet on healthy participants. A quasi-experimental study for a nutrition education and counseling intervention was conducted over 14 days among healthy Saudi participants aged 18 years and over. Assessment of dietary intake using 3-day food records was conducted at the baseline and 2-week follow-up. Participants attended an online educational session using the Zoom application illustrating instructions for a low-emulsifier diet. Daily exposure to emulsifiers was evaluated and nutrient intake was measured. A total of 30 participants completed the study. At baseline, 38 emulsifiers were identified, with a mean ± SD exposure of 12.23 ± 10.07 emulsifiers consumed per day. A significant reduction in the mean frequency of dietary emulsifier intake was observed at the end of the intervention (12.23 ± 10.07 vs. 6.30 ± 7.59, p < 0.01). However, intake of macronutrients and micronutrients was significantly reduced (p < 0.05). Good adherence to the diet was achieved by 40% of the participants, and 16.66% attained a 50% reduction of emulsifier intake. The study demonstrates that a low-emulsifier diet provided via dietary advice is feasible to follow and tolerable by healthy participants. However, the diet still needs further investigation and assessment of it is nutritional intake and quality before implementing it in patients with inflammatory bowel disease who are at high risk of poor nutritional intake.

Testing the Arabic-Saudi Arabia version of the Rome IV Diagnostic Questionnaire for functional gastrointestinal disorders for Children living in Saudi Arabia.

Functional gastrointestinal disorders (FGID) are a worldwide phenomenon described by painful, recurrent or chronic gastrointestinal (GI) symptoms. Variable types of FGID exist in a significant portion of children in Saudi Arabia (SA). While the studies and reports on child FGID are limited, the available ones show a notable significance of FGID in children in SA. The self-report Rome IV Diagnostic Questionnaire (DQ) globally recognizes the selection of symptom criteria and incidence thresholds. Using such a questionnaire would help clinicians provide a provisional diagnosis, serve as a case definition for epidemiological surveys, and identify inclusion criteria for clinical trials. This research aimed to pilot test the collective FGIDs prevalence among preschool children in Jeddah city and its countryside of Saudi Arabia, using Rome IV DQ in Arabic-SA. Of the 59 responses, 11.8% (n = 7), 5% (n = 3), 1 (1.6%), and 1 (1.6%) participants have functional dyspepsia, functional constipation, functional irritable bowel syndrome, and functional aerophagia, respectively according to the Rome IV criteria. The tested translated DQ in this study was the first translated version available in Arabic- SA, which could provide researchers and clinicians in SA with a diagnostic tool for FGIDs. However, because this study is a pilot study in a new field, the conclusions cannot be extrapolated to the demographic of the targeted population of children. The same researchers plan a larger study to use the current results and a larger calculated sample to assess FGIDs prevalence in children 4+ years old in Jeddah and its countryside, Saudi Arabia.

Development and validation of limited sampling strategies for tacrolimus and mycophenolate in steroid-free renal transplant regimens.

PURPOSE: 1) To develop and validate limited sampling strategies (LSSs) for tacrolimus (TAC) and mycophenolic acid (MPA) in renal transplant recipients not receiving corticosteroids; and 2) to evaluate predictive performance of published LSSs (for steroid-based regimens) in a steroid-free population. METHODS: On administration of steady-state morning TAC and mycophenolate mofetil doses, 12-hour serial blood samples from 28 stable renal transplant recipients were collected and measured by validated high-performance liquid chromatography methods and area under the curve (AUC) by trapezoidal rule. TAC LSSs were developed and validated by multiple regression analysis by a two-group method (index n = 18; validation n = 10) and MPA LSSs by the jackknife method (n = 28). Potential LSSs were those with r ≥ .8 (TAC) or r ≥ 0.7 (MPA) and < 3 time points within 2 hours (TAC) or 4 hours (MPA) postdose. Predictive performance was calculated and other published TAC and MPA LSSs tested using preset criteria for bias and precision of within ± 15%. RESULTS: For TAC, three three-concentration, one two-concentration, and one one-concentration model met preset criteria. The best equations were: TAC AUC = 10.338 + 7.739C0 + 3.589C2 (r = 0.956, bias = -3.4%, precision = 4.7%) and TAC AUC = 29.479 + 5.016C2 (r = 0.862, bias = 3.2%, precision = 9.7%). For MPA, only one model was identified: MPA AUC = 9.328 + 1.311C1 + 1.455C2 + 2.901C4 (r = 0.838, bias = -3.8%, precision = 14.9%). One published TAC (and no MPA) LSS in renal transplant recipients on steroid-based regimens met criteria. CONCLUSIONS: To the authors' knowledge, these LSSs are the first to be developed and validated in steroid-free renal transplant recipients and can be used to accurately predict TAC and MPA AUCs for steroid-free regimens. Because the commonly used MPA LSS is based on a steroid regimen and not predictive for steroid-free patients, the newly derived MPA LSS is being applied at the authors' institution. Other renal transplant centers may also wish to validate this equation in their own patients.

Pharmacokinetics of mycophenolic acid and its glucuronidated metabolites in stable islet transplant recipients.

Given the paucity of data on pharmacokinetics of mycophenolic acid (MPA) in islet transplant, the aim of this study was to characterize pharmacokinetic parameters of MPA and its 2 glucuronidated metabolites in stable islet transplant recipients. Sixteen subjects were entered into this open-label study after written informed consent. Upon administration of a steady-state morning mycophenolate mofetil dose, 12-hour serial concentrations of MPA and its phenolic glucuronide (MPAG) and acyl-glucuronide (AcMPAG) were measured by a validated high-performance liquid chromatography method and pharmacokinetic parameters analyzed by noncompartmental modeling. Subjects included 11 women and 5 men who had received 2.7 +/- 0.8 islet transplants. Age was 50 +/- 8 years, weight 64 +/- 11 kg, serum albumin 4.2 +/- 0.3 g/dL, and serum creatinine 1.1 +/- 0.4 mg/dL. All patients were also on tacrolimus-based steroid-free immunosuppressant regimens. Mycophenolate mofetil dosage ranged from 1 to 2 g daily (25.4 +/- 6.1 mg/kg/d). Pharmacokinetic parameters for MPA were area under the curve 42.9 +/- 21.6 microg h/mL; dose-normalized AUC 52.9 +/- 25.4 microg h/mL/g; maximal concentration (Cmax) 13.0 +/- 6.2 microg/mL; time to Cmax (tmax) 1.2 +/- 0.4 hours; minimum concentration (Cmin) 1.4 +/- 1.0 microg/mL; and MPA-free fraction 1.2% +/- 1.0%. Area under the curve ratios of MPAG/MPA and AcMPAG/MPA were 17.8 +/- 12.4 and 0.1 +/- 0.1, respectively. The wide interpatient variability in all pharmacokinetic parameters of MPA and metabolites are consistent with results from the only other published pharmacokinetic study in islet transplant recipients. A population model and a search for significant covariates may help reduce this variability. Pharmacokinetic parameters calculated in the present study, coupled with findings from the only other published MPA study in islet transplant, form a preliminary base on which to build a population model for future multicenter studies of this little-studied transplant subpopulation.

Limited sampling strategies for predicting area under the concentration-time curve of mycophenolic acid in islet transplant recipients.

BACKGROUND: Mycophenolate mofetil is widely used in islet transplant recipients and its active metabolite, mycophenolic acid (MPA), exhibits wide pharmacokinetic variability. However, to our knowledge, no limited sampling strategy (LSS) exists for monitoring MPA in this subpopulation. OBJECTIVE: To define optimal LSSs for MPA monitoring and to test their predictive performance in islet transplant recipients. METHODS: After written informed consent was obtained and upon administration of a steady-state morning mycophenolate mofetil dose, blood samples were collected at 0, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours from 16 stable islet transplant recipients. MPA concentrations were measured by a validated high-performance liquid chromatography method with ultraviolet detection and pharmacokinetic parameters analyzed by noncompartmental modeling. All 16 patients' profiles were used to develop the LSSs via multiple regression analysis. Potential LSSs were restricted to ones having R(2) 0.90 or greater and 3 or fewer time points within the first 4 hours postdose. Resulting equations were validated for their predictive performance using the jackknife method, with acceptable criteria for bias and precision preset to within +/-15%. In addition, 14 published LSSs (in the renal transplant population) were tested in our islet transplant patients. RESULTS: Five LSSs met preset criteria and had conventional sampling times: AUC = 1.783 + 1.248C1 + 0.888C2 + 8.027C4 (R2 = 0.98, bias = -3.09%, precision = 9.53%) AUC = 2.778 + 1.413C1 + 0.963C3 + 7.511C4 (R2 = 0.97, bias = -3.22%, precision = 11.02%) AUC = 1.448 + 1.239C1 + 0.271C1.5 + 9.108 C4 (R2 = 0.96, bias = -1.90%, precision = 11.46) AUC = 1.410 - 0.259C0 + 1.443C1 + 9.622C4 (R2 = 0.96, bias = -2.68%, precision = 11.53%) AUC = 1.547 + 1.417C1 + 9.448C4 (R2 = 0.96, bias = -2.46%, precision = 11.14%) where AUC = area under the concentration-time curve. None of the other published LSSs in the renal transplant population met the preset criteria for bias and precision. CONCLUSIONS: To our knowledge, these are the first precise and accurate LSSs for predicting MPA AUC developed specifically for islet transplant recipients. The LSS that we recommend is the one utilizing 2 concentrations: AUC = 1.547 + 1.417C1 + 9.448C4. This equation is convenient and clinically feasible. Other islet transplant centers may wish to validate our equation in their population or use our template as a guide to develop accurate and precise LSSs specific to their patient population.

A natural mutation in Pisum sativum L. (pea) alters starch assembly and improves glucose homeostasis in humans.

Elevated postprandial glucose (PPG) is a significant risk factor for non-communicable diseases globally. Currently, there is a limited understanding of how starch structures within a carbohydrate-rich food matrix interact with the gut luminal environment to control PPG. Here, we use pea seeds (Pisum sativum) and pea flour, derived from two near-identical pea genotypes (BC1/19RR and BC1/19rr) differing primarily in the type of starch accumulated, to explore the contribution of starch structure, food matrix and intestinal environment to PPG. Using stable isotope 13C-labelled pea seeds, coupled with synchronous gastric, duodenal and plasma sampling in vivo, we demonstrate that maintenance of cell structure and changes in starch morphology are closely related to lower glucose availability in the small intestine, resulting in acutely lower PPG and promotion of changes in the gut bacterial composition associated with long-term metabolic health improvements.

Outcomes following Serial Intragastric Balloon Therapy for Obesity and Nonalcoholic Fatty Liver Disease in a Single Centre.

Background: The incidence of nonalcoholic fatty liver disease (NAFLD) continues to parallel the rise in obesity rates. Endobariatric devices such as the intragastric balloon (IGB) may provide an alternative treatment option. Methods: Outcomes following IGB treatment in 135 patients with obesity and NAFLD (mean baseline weight 117.9 kg; BMI 41.7 kg/m2; HOMA-IR 3.6) were retrospectively examined. Clinical, anthropometric, and biochemical changes were analysed at six months and after consecutive treatment with two and three serial IGBs. Results: After six months, significant changes were seen with weight and BMI (mean reductions of 11.3 kg and 4.1 kg/m2, resp., p < 0.01 for both). Significant improvements were also seen with ALT, GGT, and HOMA-IR, with all changes corresponding with weight loss. Forty-eight patients received two IGBs, and 20 were treated with three serial IGBs. The greatest amount of total weight loss was observed after the first 6 months (mean weight lost 7.4 kg, versus 3.6 kg and 1.9 kg with two and three IGBs, resp.). Conclusions: IGB therapy is an effective, alternative nonsurgical means for weight loss in the management of obesity and NAFLD over the short term, with greatest outcomes observed after six months. Improvements in insulin resistance and hepatic transaminases correlated with weight change.

Pharmacokinetics of tacrolimus and mycophenolate mofetil in renal transplant recipients on a corticosteroid-free regimen.

PURPOSE: The pharmacokinetics of both tacrolimus and mycophenolic acid in renal transplant recipients on a corticosteroid-free regimen was evaluated. METHODS: Upon administration of steady-state morning tacrolimus and mycophenolate mofetil doses, 28 patients for whom at least three months had passed after renal transplantation underwent serial blood sample collection over a 12-hour dosing period. Whole blood concentrations of tacrolimus were measured, as were mycophenolic acid, mycophenolic acid 7-0-glucuronide (MPAG), and acyl glucuronide MPAG (AcMPAG) concentrations. Pharmacokinetic parameters were then analyzed by conventional noncompartmental modeling. RESULTS: The mean ± S.D. pharmacokinetic parameters for tacrolimus, normalized to a dose of 1 mg, were as follows: area under the concentration-time curve (AUC), 52.6 ± 24.8 µg · hr/L/mg; maximum concentration (C(max)), 8.0 ± 3.3 µg/L/mg; time to C(max) (t(max)), 1.8 ± 1.0 hr; and minimum concentration (C(min)), 2.6 ± 1.4 µg/L/mg. The mean ± S.D. pharmacokinetic parameters for mycophenolic acid, normalized to a mycophenolate mofetil dose of 1 g, were AUC, 26.9 ± 13.2 µg ·hr/mL/g; C(max), 17.5 ± 5.4 µg/mL/g; t(max), 0.9 ± 0.6 hr; and C(min), 1.5 ± 1.1 µg/mL/g. The free fraction of mycophenolic acid was 1.8% ± 0.7%. AUC ratios of MPAG:mycophenolic acid and AcMPAG:mycophenolic acid were 13.0 ± 5.8 and 0.1 ± 0.2, respectively. CONCLUSION: Overall exposure and C(min) values for tacrolimus were similar but C(max) values were higher than those documented in renal transplant patients treated with corticosteroid-based regimens. This may have clinical implications in corticosteroid-free patients experiencing symptoms of tacrolimus toxicity despite trough levels within target ranges. Mycophenolic acid exposure increased with time, but AUC values fell within the range expected for patients receiving concurrent corticosteroids.