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

NCT06432569 | Completed

• 1 other identifier: 5475-AO-22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Evaluation of the variation of gut microbiota composition (Microbiota test )

  Collection of faecal sample for the assessment of the faecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit which is used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq , in order to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.

  9 months

Secondary Outcomes (3)

• Evaluation of intestinal permeability(4 sugar test: Gastropack)

  12 months

• Evaluation of Gastrointestinal symptoms( questionary)

  4 months

• Evaluation of Quality of Life (IBS-SSS score) (questionary)

  4 months

Study Arms (2)

ButirBioma+PeaBioma

ACTIVE COMPARATOR

Treatment : 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1

Dietary Supplement: ButirBioma + PeaBioma

Placebo

PLACEBO COMPARATOR

Treatment Placebo :(3+3/day capsules of starch).

Dietary Supplement: Placebo

Interventions

ButirBioma + PeaBioma DIETARY_SUPPLEMENT

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.

ButirBioma+PeaBioma

Placebo DIETARY_SUPPLEMENT

Placebo( 3+3 cps/die)

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● IBS patients (both males and females) with positive diagnosis based on Rome IV criteria (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

You may not qualify if:

• 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 the withdrawal 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 and mast 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Edoardo Vinvenzo Savarino

Padua, Padua, 35128, Italy

Location

Study Officials

• Edoardo Savarino, Prof,MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 the 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.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: May 29, 2024
• Study Start: March 8, 2024
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)