Faecal Microbiota Transplantation in Irritable Bowel Syndrome

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Thomayer University Hospital
Updated on 23 June 2021

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 patientscolonic microbiota might ameliorate the condition. Here we test an intervention by faecal microbiota transplantation of artificially inflated microbiome diversity, versus autoclaved placebo.

Description

Three-groups, double-blind, placebo-controlled, randomised, cross-over study in adult patients diagnosed with IBS (diarrhoeal or mixed form) according to Rome IV criteria. Each study subject will undergo two pairs of faecal microbiota transplantation (a total of four enemas for each patient), with the pairs of transfers being eight weeks apart. The active intervention substance is a mixed stool microbiota derived from healthy individuals, screened for infectious diseases according to European consensus conference on faecal microbiota transplantation guidelines, and who were preselected for high alpha diversity of their microbiome and distance in community ordination from IBS patients microbiota. Placebo is the same mixture, inactivated by autoclaving.

Details
Condition Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome Mixed
Treatment Faecal microbiota transplantation with active study microbiota first, Faecal microbiota transplantation with inactive autoclaved study microbiota first, Faecal microbiota transplantation with inactive autoclaved study microbiota only
Clinical Study IdentifierNCT04899869
SponsorThomayer University Hospital
Last Modified on23 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) or Irritable Bowel Syndrome with mixed bowel habits (IBS-M) according to the Rome IV criteria

Exclusion Criteria

The use of antibiotics within one month prior to faecal microbiota transplantation
History of inflammatory bowel disease or gastrointestinal malignancy, systemic autoimmune diseases (ongoing or in history)
The use of probiotics within one month prior to faecal microbiota transplantation
HIV infection or other active infection
Previous abdominal surgery (other than appendectomy or cholecystectomy or hernioplasty or cesarean section)
Renal or hepatic disease (both defined by biochemistry workup)
Diabetes mellitus, abnormal thyroid functions not controlled by thyroid medications
Bipolar disorder or schizophrenia (ongoing or history thereof), moderately severe depression defined by Patient Health Questionnaire-9 (PHQ-9) score > 15
Anxiety defined by a Generalised Anxiety Disorder 7 (GAD7) score > 10
Current pregnancy and lactation
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