Individualized microbiotas dictate the impact of dietary fiber on colitis sensitivity.

BACKGROUND: The observation that the intestinal microbiota is  central in the development of IBD suggests that dietary fiber, the microbiota's primary source of nourishment, could play a central role in these diseases. Accordingly, enriching diets with specific soluble fibers remodels microbiota and modulates colitis sensitivity. In humans, a recent study suggests that the microbiota of select IBD patients might influence the impacts they would experience upon fiber exposure. We sought here to define the extent to which individual microbiotas varied in their responsiveness to purified soluble fiber inulin and psyllium. Moreover, the extent to which such variance might impact proneness to colitis. RESULTS: We observed a high level of inter-individual variation in microbiota responsiveness to fiber inulin and psyllium: while microbiotas from select donors exhibited stark fiber-induced modulation in composition, pro-inflammatory potential, and metabolomic profile, others were only minimally impacted. Mice transplanted with fiber-sensitive microbiomes exhibited colitis highly modulated by soluble fiber consumption, while mice receiving fiber-resistant microbiotas displayed colitis severity irrespective of fiber exposure. CONCLUSION: The extent to which select soluble fibers alter proneness to colitis is highly influenced by an individual's microbiota composition and further investigation of individual microbiota responsiveness toward specific dietary fiber could pave the way to personalized fiber-based intervention, both in IBD patients and healthy individuals. Video Abstract.

Psyllium Fiber Protects Against Colitis Via Activation of Bile Acid Sensor Farnesoid X Receptor.

BACKGROUND & AIMS: Fiber-rich foods promote health, but mechanisms by which they do so remain poorly defined. Screening fiber types, in mice, revealed psyllium had unique ability to ameliorate 2 chronic inflammatory states, namely, metabolic syndrome and colitis. We sought to determine the mechanism of action of the latter. METHODS: Mice were fed grain-based chow, which is naturally rich in fiber or compositionally defined diets enriched with semi-purified fibers. Mice were studied basally and in models of chemical-induced and T-cell transfer colitis. RESULTS: Relative to all diets tested, mice consuming psyllium-enriched compositionally defined diets were markedly protected against both dextran sulfate sodium- and T-cell transfer-induced colitis, as revealed by clinical-type, histopathologic, morphologic, and immunologic parameters. Such protection associated with stark basal changes in the gut microbiome but was independent of fermentation and, moreover, maintained in mice harboring a minimal microbiota (ie, Altered Schaedler Flora). Transcriptomic analysis revealed psyllium induced expression of genes mediating bile acids (BA) secretion, suggesting that psyllium's known ability to bind BA might contribute to its ability to prevent colitis. As expected, psyllium resulted in elevated level of fecal BA, reflecting their removal from enterohepatic circulation but, in stark contrast to the BA sequestrant cholestyramine, increased serum BA levels. Moreover, the use of BA mimetics that activate the farnesoid X receptor (FXR), as well as the use of FXR-knockout mice, suggested that activation of FXR plays a central role in psyllium's protection against colitis. CONCLUSIONS: Psyllium protects against colitis via altering BA metabolism resulting in activation of FXR, which suppresses pro-inflammatory signaling.

The effect of psyllium supplementation on blood pressure: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND/AIMS: Global incidence of hypertension is estimated to be, in excess of, one billion people, and given the efficacy of soluble dietary fibers, in particular, Psyllium, to positively impact blood pressure in patients with hypertension, it is of clinical importance that consensus on its supplementation be established. Therefore, the aim of the study was systematically review and meta-analyze the effect of psyllium supplementation on blood pressure of hypertensive patients in randomized controlled trials. METHODS: We searched six universal databases including; Pubmed/Medline, Ovid, Cochrane Library, Google Scholar, Embase, and Scopus until November 2018. Both combined and stratified analyzes were conducted. A fixed-effects or random- effects model was used to assess the mean effect sizes. RESULTS: An eventual 11 trials with 592 participants were considered as eligible for inclusion in the present meta-analysis. The meta-analysis revealed a significant reduction of 2.04 mmHg in systolic blood pressure (weighted mean difference, -2.04; 95% confidence interval, -2.82 to -1.63; p < 0.001). Whilst meta-regression highlighted that the hypotensive effect of psyllium was stronger in subjects with higher baseline blood pressure. CONCLUSION: Given the overarching benefits and lack of reported side effects, particularly for hypertensive patients, health care providers and clinicians should consider the use of psyllium supplementation for the treatment or abatement of hypertension, or hypertensive symptoms.

[Plantago psyllium-secondary anaphylaxis. Case report]. / Anafilaxia secundaria a plantago psyllium. Reporte de caso.

BACKGROUND: Psyllium is a derivative of Plantago ovata ground seed and husk that is used as bulk-forming laxatives owing to its hydrocolloid properties. CASE REPORT: 43-year-old female nurse with previous diagnosis of drug allergy and allergic rhinitis who, after the preparation and administration of a laxative, developed rhinoconjunctivitis symptoms, urticarial syndrome, angioedema and bronchospasm, which led to conclude that she had an anaphylactic reaction. She was treated with adrenaline, corticosteroids and antihistamines. After symptom resolution, with in vivo tests by means of the skin prick technique and by in vitro assay (specific IgE), hypersensitivity to plantago psyllium was determined. DISCUSSION: Most cases of anaphylaxis have been reported with psyllium ingestion, since, through that route, antigenic burden is higher. It should be noted that, even when exposure in the described patient was only by inhalation, manifestations were life-threatening.

Antecedentes: El psyllium es un derivado de la semilla y cáscara pulverizada de Plantago ovata, que se usa como laxante de volumen debido a sus propiedades hidrocoloides. Reporte de caso: Mujer de 43 años, de profesión enfermera, con diagnóstico de alergia a fármacos y rinitis alérgica, quien posterior a la preparación y administración de un laxante presentó síntomas rinoconjuntivales, síndrome urticariforme, angioedema y broncoespasmo, por lo que se concluyó que presentaba anafilaxia. Fue tratada con adrenalina, corticoides y antihistamínicos. Después de la resolución del cuadro, por pruebas in vivo mediante técnica de punción cutánea y por estudio in vitro (IgE específica) se determinó hipersensibilidad a plantago psyllium. Discusión: La mayoría de los casos de anafilaxia se ha reportado por ingestión de psyllium debido a que por esa vía es mayor la carga antigénica. Llama la atención la paciente descrita, en quien la exposición fue únicamente por inhalación, sin embargo, las manifestaciones que presentó fueron potencialmente letales.

Catastrophic gastric rupture in a horse secondary to psyllium pharmacobezoars.

A mare was euthanized because of gastric rupture secondary to complete duodenal obstruction by 2 bezoars located in the pylorus and proximal duodenum. Infrared spectroscopy showed that the bezoars were composed of psyllium. The mare had been receiving treatment with a pelleted psyllium product at 4 times the recommended dosage. Veterinarians should be aware that treatment of colic in horses with pelleted psyllium products could be associated with gastric impaction.

Rupture gastrique catastrophique secondaire à des pharmacobézoards de psyllium en boulettes chez un cheval. Une jument a été euthanasiée en raison d'une rupture gastrique secondaire à une obstruction duodénale complète par deux bézoards situés dans le pylore et le duodénum proximal. La spectroscopie infrarouge a montré que les bézoards se composaient de psyllium. La jument avait reçu un traitement composé d'un produit de psyllium en boulettes à quatre fois la dose recommandée. Les vétérinaires devraient être au courant que le traitement des coliques chez les chevaux avec des produits de psyllium en boulettes pourrait être associé à une impaction gastrique.(Traduit par Isabelle Vallières).

Satiety effects of psyllium in healthy volunteers.

Controlling hunger between meals is a challenge for many individuals. This manuscript comprises 2 sequential clinical trials investigating the effects of psyllium (Metamucil) on satiety, both using a randomized, double-blind, placebo-controlled cross-over design. The first study determined the effects of 3.4 g, 6.8 g, and 10.2 g of psyllium taken before breakfast and lunch for 3 days. The second study determined the effects of 6.8 g (taken before breakfast and lunch on Days 1 and 2 and before breakfast on Day 3) on the satiety of participants receiving an energy restricted meal in the morning (breakfast) for 3 days. Efficacy endpoints were mean inter-meal hunger, desire to eat, and Satiety Labeled Intensity Magnitude Visual Analog Scale scores. In Study 1, all 3 psyllium doses resulted in directional or statistically significant mean reductions in hunger and desire to eat, and increased fullness between meals compared to placebo, with both higher doses better than placebo or 3.4 g. The 6.8 g dose provided more consistent (p ≤ 0.013) satiety benefits versus placebo. In Study 2, satiety was assessed similarly to Study 1. A significant (p ≤ 0.004) decrease in the 3-day mean hunger and desire to eat, as well as an increase in fullness for psyllium relative to placebo was observed. Most adverse events were mild gastrointestinal symptoms and were similar for psyllium compared to placebo. These results indicate that psyllium supplementation contributes to greater fullness and less hunger between meals.

Psyllium fiber improves glycemic control proportional to loss of glycemic control: a meta-analysis of data in euglycemic subjects, patients at risk of type 2 diabetes mellitus, and patients being treated for type 2 diabetes mellitus.

BACKGROUND: A number of health benefits are associated with intake of soluble, viscous, gel-forming fibers, including reduced serum cholesterol and the attenuation of postprandial glucose excursions. OBJECTIVE: We assess the effects of psyllium, which is a soluble, gel-forming, nonfermented fiber supplement, on glycemic control in patients who were being treated for type 2 diabetes mellitus (T2DM) and in patients who were at risk of developing T2DM. DESIGN: A comprehensive search was performed of available published literature (Scopus scientific database) and clinical records stored by Procter & Gamble with the use of key search terms to identify clinical studies that assessed the glycemic effects of psyllium in nondiabetic, pre-T2DM, and T2DM patients. RESULTS: We identified 35 randomized, controlled, clinical studies that spanned 3 decades and 3 continents. These data were assessed in 8 meta-analyses. In patients with T2DM, multiweek studies (psyllium dosed before meals) showed significant improvement in both the fasting blood glucose (FBG) concentration (-37.0 mg/dL; P < 0.001) and glycated hemoglobin (HbA1c) [-0.97% (-10.6 mmol/mol); P = 0.048]. Glycemic effects were proportional to baseline FBG; no significant glucose lowering was observed in euglycemic subjects, a modest improvement was observed in subjects with pre-T2DM, and the greatest improvement was observed in subjects who were being treated for T2DM. CONCLUSIONS: These data indicate that psyllium would be an effective addition to a lifestyle-intervention program. The degree of psyllium's glycemic benefit was commensurate with the loss of glycemic control. Because the greatest effect was seen in patients who were being treated for T2DM, additional studies are needed to determine how best to incorporate psyllium into existing prevention and treatment algorithms with concomitant hypoglycemic medications.

Loperamide Versus Psyllium Fiber for Treatment of Fecal Incontinence: The Fecal Incontinence Prescription (Rx) Management (FIRM) Randomized Clinical Trial.

BACKGROUND: Fecal incontinence is a devastating condition with few US Food and Drug Administration-approved pharmacologic treatment options. Loperamide and psyllium, both first-line treatments, have different mechanisms of action without any comparative data. OBJECTIVE: The purpose of this study was to examine the effectiveness and tolerability of loperamide compared with psyllium for reducing fecal incontinence. We hypothesized that psyllium fiber supplementation would be more effective than loperamide for reducing fecal incontinence episodes and have fewer adverse effects. DESIGN: We conducted a randomized, double-blind, placebo-controlled crossover trial comparing loperamide (followed by psyllium) with psyllium (followed by loperamide). SETTINGS: Our sites included outpatient clinics within a Veterans Affairs medical center and university affiliate. PATIENTS: Participants included community-dwelling adults (n = 80) with at least 1 fecal incontinent episode on a 7-day bowel diary. INTERVENTION: Participants received either daily loperamide (plus placebo psyllium powder) or psyllium powder (plus loperamide placebo) for 4 weeks. After a 2-week washout, participants crossed over to 4 weeks of alternate treatment. MAIN OUTCOME MEASURES: The primary outcome was the number of fecal incontinence episodes from 7-day bowel diaries. Secondary outcomes included symptom severity, quality of life, and tolerability. RESULTS: Mean age was 60.7 ± 10.1 years; 68% were men. After determining nonsignificant carryover effects, combined analyses showed no differences between the loperamide and psyllium groups for reducing fecal incontinent episodes, symptom severity, or quality of life. Within each group, both loperamide and psyllium reduced fecal incontinent episodes and improved symptom severity and quality of life. Constipation occurred in 29% of participants for loperamide vs 10% for psyllium. LIMITATIONS: Limitations include the washout period length and dropout rate after crossing over to the second intervention. CONCLUSIONS: Both loperamide and psyllium improve fecal incontinence. Loperamide was associated with more adverse effects, especially constipation.

Small bowel obstruction following computed tomography and magnetic resonance enterography using psyllium seed husk as an oral contrast agent.

The authors report a case series describing four patients who developed small bowel obstruction following the use of psyllium seed husk as an oral contrast agent for computed tomography or magnetic resonance enterography. Radiologists who oversee computed tomography and magnetic resonance enterography should be aware of this potential complication when using psyllium seed husk and other bulking agents, particularly when imaging patients with known or suspected small bowel strictures or active inflammation.

A bulking agent may lead to adrenal insufficiency crisis: a case report.

Adrenal insufficiency is a life-threatening disorder which must be treated with glucocorticoid replacement and needs permanent dose adjustment during patient's different somatic situations. Insufficient glucocorticoid doses result in adrenal crisis and must be treated with intravenous hydrocortisone. The patient was known with Adrenal insufficiency and was treated optimally with fludrocortisone and prednisolone since seven years with no history of adrenal crisis. The patient was admitted with abdominal pain, weakness, fatigue and nausea developed 3-4 days after taking psyllium, a bulking agent, prescribed by a surgeon to diagnose anal fissure. Detailed medical history, physical examinations, laboratory and imaging examinations did not approve any other cause of adrenal crisis. Psyllium may interfere with gastrointestinal absorption of prednisolone and/or fludrocortisone and trigger acute adrenal crisis in patients with adrenal insufficiency.

Beneficial health properties of psyllium and approaches to improve its functionalities.

Psyllium is an excellent dietary source for both soluble and insoluble fibers and has been used in supplemental and food products for its beneficial health effects. The strong water-absorbing and gelling capacities have made it a great challenge to incorporate psyllium in foods at the level needed to claim health benefits on the label. This review is focused on the approaches to improve the functionality, sensory property, and bioactivity of psyllium. Also included is a brief summary of the health beneficial effects of psyllium, along with its possible adverse effects. The information may be useful for those in psyllium research and functional food development.

Cholesterol reduction using psyllium husks - do gastrointestinal adverse effects limit compliance? Results of a specific observational study.

PURPOSE: Despite known cholesterol lowering effects the use of psyllium husk (Plantaginis ovatae testa) in Germany for hypercholesterolemia is limited compared to their use as a laxative. To investigate whether use in hypercholesterolemia is limited due to adverse effects on the gastrointestinal system, a prospective observational study was conducted. METHODS: Sixty-two outpatients with documented hypercholesterolemia and complaints of constipation were identified from an academic clinical center. Treatment with 3.5g psyllium husk preparation administered three times daily was initiated and patients were monitored at weekly intervals. Gastrointestinal symptoms were quantified using a validated Nepean Dyspepsia Index modified to identify both upper and lower abdominal symptoms. Diaries and study medication records were used to evaluate compliance. RESULTS: Fifty-four of 62 patients enrolled in the study completed the study protocol with 4 subjects discontinuing due to adverse reactions associated with psyllium husks. Total cholesterol was significantly decreased from 252+/-39mg/dl before treatment to 239+/-37mg/dl after 3 weeks of treatment. Similarly, low density lipoprotein (LDL)-cholesterol decreased from 174+/-34 to 162+/-31mg/dl during the study. Triglycerides and high density lipoprotein (HDL) were unchanged. Gastrointestinal symptoms were rated lower at the end than at the beginning of the study. In week 1 most of the patients reported gastrointestinal symptoms and also gastrointestinal adverse reactions, which however, showed a decrease from week 1 to weeks 2 and 3 in the diaries. Patient response to study medication was positive for patients completing the study. CONCLUSIONS: Psyllium husk preparations may be a therapeutic option for patients with mild to moderately elevated cholesterol levels. Adverse gastrointestinal symptoms associated with the preparation appear to be transient in some of the patients. Compliance may be optimized with adequate patient counseling.

Randomised study to compare the efficacy and safety of isapgol plus atorvastatin versus atorvastatin alone in subjects with hypercholesterolaemia.

Soluble fibre has been shown to augment the cholesterol-lowering effects of low-fat diets in individuals with mild to moderate hypercholesterolaemia. Combination therapy with a statin poses advantages in certain settings and may allow use of lower doses of multiple drugs rather than maximum doses of a single drug. The primary objective of the study was to compare the efficacy of combination of isapgol and atorvastatin versus atorvastatin alone, in the same dose, in reduction of low-density lipoprotein cholesterol (LDL-C), total-cholesterol levels in hypercholesterolaemic patients after 12 weeks of therapy. In a 12-week study, 100 subjects from both sexes and of > 20 years having hyperlipidaemia, with LDL-C level > 130 mg/dl and total cholesterol > 220 mg/dl were included, and were randomised to receive either a combination of isapgol powder (Naturolax) 5.6 g twice daily and atorvastatin 10 mg once daily or atorvastatin 10 mg once daily alone orally. Serum levels of total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglyceride were assessed at 8 and 12 weeks. Ninety-seven patients completed the study. At the end of the 8th week, both the groups had a significant reduction in mean LDL-C (20.5% in isapgol + atorvastatin group and 16.0% among atorvastatin alone group) as compared to baseline. But between the groups, however, the difference was not significant. At the end of the 12th week fall in LDL-C at 31.4% for isapgol + atorvastatin was significantly greater than 22.8% among the atorvastatin group (p < 0.05). Serum total cholesterol, HDL-C and triglyceride were significantly lowered within the groups at 8th and 12th weeks but between groups, the difference was not significant. Comparison of adverse events profile in both the groups shows that more number of patients from atorvastatin alone group (n = 14, 28%) had adverse reactions than the number of patients from the combination group (n = 4, 8%; p < 005).

Different effect of psyllium and guar dietary supplementation on blood pressure control in hypertensive overweight patients: a six-month, randomized clinical trial.

In the setting of a six-month, open-label clinical trial, 141 consecutively enrolled, hypertensive, overweight patients were randomized to the oral ingestion of psyllium powder or guar gum 3.5 gr t.i.d., to be taken 20 min before the main two meals, or to standard diet. Both fibers improved significantly BMI, FPG, FPI, HOMA Index, HbA1c, LDL-C, and ApoB. Psyllium supplementation only exerted a significant improvement in plasma TG concentration, in SBP and DBP. In our study, six-month supplementation with psyllium fiber, but not with guar fiber nor standard diet, appears to significantly reduce both SBP and DBP in hypertensive overweight subjects.

Nutriceuticals in cardiovascular disease: psyllium.

In recent years, there has been a growing interest in the use of dietary fiber in health maintenance and disease prevention. A deficiency of fiber in the Western diet may be contributing to the current epidemics of diabetes mellitus, coronary artery disease (CAD), and colonic cancer. The awareness of fiber as a dietary supplement may have contributed to the reported 30% decline in death rate from CAD observed over the past 15 years. Psyllium is a soluble gel-forming fiber that has been shown to bind to the bile acids in the gut and prevent their normal reabsorption, similar to the bile acid sequestrant drugs. Psyllium is useful as an adjunct to dietary therapy (step 1 or step 2 American Heart Association [AHA] diet) in the treatment of patients with mild-to-moderate hypercholesterolemia. In combination with other cholesterol-lowering drugs, such as statins, psyllium provides an added benefit on cholesterol lowering, and is well tolerated and cost-effective.

Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized as safe and effective (GRASE) and are misbranded. This final rule includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; dispersed, suspended, or partially dissolved in liquid prior to swallowing; chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; or sprinkled over food. FDA is issuing this final rule after considering reports of esophageal obstruction associated with the use of psyllium laxatives in granular dosage form. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products.

Psyllium as therapeutic and drug delivery agent.

There is no doubt that fibers, in particular viscous dietary fibers, have positive effects on human health, both in the prevention and in treatment of chronic diseases. Dietary fibers from psyllium have been used extensively both as pharmacological supplements, food ingredients, in processed food to aid weight control, to regulation of glucose control for diabetic patients and reducing serum lipid levels in hyperlipidemics. Keeping in view, the pharmacological importance of psyllium polysaccharide and its gel-forming nature, this article discusses the therapeutic value of psyllium for the treatment of constipation, diarrhea, irritable bowel syndrome, inflammatory bowel disease-ulcerative colitis, colon cancer, diabetes and hypercholesterolemia and exploitation of psyllium for developing drug delivery systems.