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NCT Number: NCT06432569

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

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 )

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Key information

Conditions

Irritable Bowel Syndrome With Diarrhea

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edoardo Vinvenzo Savarino

Padua, 35128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ● 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

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 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

Treatment and study plan

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.

Placebo

Dietary Supplement

Placebo( 3+3 cps/die)

Primary outcomes

  1. Evaluation of the variation of gut microbiota composition (Microbiota test )

    Time frame: 9 months

    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.

Secondary outcomes

  1. Evaluation of intestinal permeability(4 sugar test: Gastropack)

    Time frame: 12 months

    • Analysis of mannitol( normal range 15-25%), lactulose( n.r. 0,45%-0,75%), sucrose(normal < 0,15%) and sucralose( normal<1,5%); L/M (normal <0.03%; borderline 0,03%-0,09%; >0.09 severe):
    • a capillary blood sample for the detection of Zonulin (Healthy gut Kit) )/Immundiagnostik AG )( normal cut-off 6-10 ng/mL)

  2. Evaluation of Gastrointestinal symptoms( questionary)

    Time frame: 4 months

    Every evening during the two treatment periods, subjects must record a VAS(Visual Analogue Scale : 1-10; 1= non pain; 10= worst pain possible) questionnaire to assess gastrointestinal symptoms and the Stool Bristol Scale.( 1-7; normal 3-4)

  3. Evaluation of Quality of Life (IBS-SSS score) (questionary)

    Time frame: 4 months

    At the visit time points, subjects will have to record the IBS-SSS score( points 75-174 mild, 175-300 moderate; >300 severe)

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Evaluation of Butyrate and Palmitoylethanolamide Effects on Intestinal Permeability and Microbiota Gut Composition in Patients With Irritable Bowel Syndrome - A Double-blind, Placebo-controlled Crossover Randomized Study

Acronym: B/P3_1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 29, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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