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Faecal Microbiota Transplantation in Irritable Bowel Syndrome

NCT04899869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-05-24

No results posted yet for this study

Summary

Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that modification of patients´colonic microbiota might ameliorate the condition. Here we test an intervention by faecal microbiota transplantation of artificially inflated microbiome diversity, versus autoclaved placebo.

Conditions

  • Irritable Bowel Syndrome With Diarrhea
  • Irritable Bowel Syndrome Mixed

Interventions

OTHER

Faecal microbiota transplantation with active study microbiota first

2x enema with active study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota

OTHER

Faecal microbiota transplantation with inactive autoclaved study microbiota first

2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with active study microbiota

OTHER

Faecal microbiota transplantation with inactive autoclaved study microbiota only

2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota

Sponsors & Collaborators

  • Charles University, Czech Republic

    collaborator OTHER

  • Thomayer University Hospital

    lead OTHER

Principal Investigators

  • Pavel Kohout · Thomayer University Hospital, Prague, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2024-03-27
Completion
2024-04-29

Countries

  • Czechia

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 NCT04899869 on ClinicalTrials.gov