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

NCT06432569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-10

No results posted yet for this 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 )

Conditions

  • Irritable Bowel Syndrome With Diarrhea

Interventions

DIETARY_SUPPLEMENT

ButirBioma + PeaBioma

randomized in a 1:1 ratio to treatment Butir+Pea or treatment with Placebo for six weeks. After the first treatment period, there is a 14-day washout period.

DIETARY_SUPPLEMENT

Placebo

Placebo( 3+3 cps/die)

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Edoardo Savarino, Prof,MD · University of Padova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-08
Primary Completion
2025-07-07
Completion
2025-07-07

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06432569 on ClinicalTrials.gov