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The Efficacy of Sodium Butyrate and Probiotics in Patients With Irritable Bowel Syndrome

NCT05013060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-02-28

No results posted yet for this study

Summary

According to current IBS management guidelines, probiotic administration reduces IBS-associated symptoms and improves the quality of life. The purpose of this study is to assess the effects of the combined formulation comprising microencapsulated sodium butyrate and a probiotic mixture of two Lactobacillus strains (L. rhamnosus and L. acidophilus) and three Bifidobacterium strains (B. longum, B. bifidum, and B. lactis) on the incidence and severity of clinical symptoms in patients diagnosed with irritable bowel syndrome (IBS) based on the Rome IV criteria.

Microencapsulated sodium butyrate is a short-chain fatty acid (SCFA) with biological effects on the gastrointestinal mucosa; it constitutes a key source of energy for enterocytes. Butyrate was shown to have a trophic effect on the colon epithelium and to help restore the disrupted structural and functional integrity of the gastrointestinal tract. These unique properties of sodium butyrate result in its beneficial effects on the abdominal symptoms (such as diarrhea, constipation, abdominal pain) in patients with IBS. This study will assess the effects of the mixture of sodium butyrate and multi-strain probiotic on the rate and severity of clinical symptoms in IBS patients, by taking into account their nutritional status and body composition.

Conditions

  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Probiotics and microcapsulated sodium butyrate

The patients who give their consent to take part in this study, will receive an oral microencapsulated sodium butyrate and a mixture of probiotics formulation 2 times a day for a period of 12 weeks.

DIETARY_SUPPLEMENT

Maltodextrin

The patients who give their consent to take part in this study will receive an oral maltodextrin as placebo 2 times a day for a period of 12 weeks.

Sponsors & Collaborators

  • Medical University of Lodz

    collaborator OTHER

  • Nordic Biotic Sp. z o.o.

    lead INDUSTRY

Principal Investigators

  • Anita Gąsiorowska, MD, PhD · Medical University of Lodz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2023-09-30
Completion
2024-01-31

Countries

  • Poland

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 NCT05013060 on ClinicalTrials.gov