Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1)

Phase

N/A

Condition

Colic

Hyponatremia

Fecal Incontinence

Treatment

Placebo

ButirBioma + PeaBioma

Clinical Study ID

NCT06432569

5475-AO-22

Ages 18-70
All Genders
Accepts Healthy Volunteers

Study Summary

Evaluation of the effects of butyrate ( BitirBioma) and palmitoylethanolamide( PEA=PeaBioma) on intestinal permeability and gut microbiota composition in patients with irritable bowel syndrome.

Study B/P 3_1 is an interventional study involving the use of food supplements on the market (BitirBioma Plus and PeaBioma Plus), single-center, double-blind, placebo-controlled, crossover, randomized, in n=50 patients with bowel syndrome irritable, diarrheal and mixed variant (IBS-D and IBS-M), lasting for one year.

The study has two arms: Group 1: n=25 Treatment A e Group 2: n=25 Treatment B (with - Treatment A: 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 - Treatment B: Placebo (3+3/day capsules of starch).

Eligible subjects with IBS will be randomized in a 1:1 ratio to treatment A or treatment B for six weeks. After the first treatment period, there is a 14-day washout period.

Hence, individuals will be treated with B/A treatment for additional six weeks, according to the crossover design.

In the two treatment periods, subjects will be required to complete a visual analogue score VAS questionnaire to assess gastrointestinal symptoms and Stool Bristol Scales. During the visit, the subjects will have to record Questionnaire Rome IV to evaluate their quality of life. At the same time, it will be theirs required to provide:

fecal sample for the evaluation of the composition of fecal microbiota (Biomaplan Kit)
a urine sample for the evaluation of intestinal permeability (Gastropack) a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG )
a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG )

Eligibility Criteria

Inclusion

Inclusion Criteria:

● IBS patients (both males and females) with positive diagnosis based on Rome IVcriteria (IBS-D and IBS-M)
Age in the range 18-70 years
Subjects capable of conforming to the study protocol
Subjects who have given their free and informed consent

Exclusion

Exclusion Criteria:

-Any relevant organic, systemic or metabolic disease, including celiac disease, IDDM (Insulin- Dependant Diabetes Mellitus), Insulin-Independent Diabetes Mellitus, metabolic syndrome, pelvic organ prolapses, urinary incontinence, ulcerative colitis, Crohn's disease, microscopic colitis, infectious colitis, ischemic colitis, complicated diverticular disease.

Subjects with untreated food intolerance, i.e. remaining symptomatic despite thewithdrawal of the suspected food
Prior major gastrointestinal surgeries
Females of childbearing potential, in the absence of effective contraceptive methods
Subjects who become unable to conform to protocol
Subjects who are continuously taking contact laxatives
Subjects who are treated continuously with glucocorticoids, anti-histaminergic andmast cell stabilizer drugs
Subjects who are treated continuously with trimebutine
Recent history or suspicion of alcohol abuse or drug addiction
Subjects who are treated with antibiotics or probiotics

Study Design

Placebo

March 08, 2024

July 07, 2025

Study Description

Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon, characterized by relapsing and remitting mucosal inflammation. It presents with symptoms like bloody diarrhea, rectal urgency, fatigue, and abdominal pain. While various therapies are available for managing UC, including medications like amino salicylates, corticosteroids, immunomodulators, and biologics, there's ongoing research into supportive treatments like probiotics.

Probiotics are beneficial microorganisms that can positively influence gut health by modifying the gut microbiota, improving intestinal barrier function, and balancing immune response. Several studies have investigated their efficacy in UC management. Notably, the probiotic mixture VSL#3, containing strains of Lactobacillus and Bifidobacteria, has shown promising results in inducing remission in UC patients.

Other probiotic products like E. coli Nissle 1917, L. rhamnosus GG, and L. casei DG have also demonstrated effectiveness in maintaining disease remission or prolonging relapse-free periods in UC patients. The product Prolife 10 FORTE, containing multiple strains of Lactobacillus, Bifidobacteria, and Bacillus coagulans, along with prebiotic components and vitamins, has shown potential in positively influencing gut microbiota composition and metabolic activity in healthy individuals.

Based on these promising findings, further investigation is warranted to evaluate the potential of Prolife 10 FORTE in improving the gut microbiota composition of UC patients during the remission phase.

Connect with a study center

Edoardo Vinvenzo Savarino
Padua, 35128
Italy
Site Not Available

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