Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-17

Study Completion Date

2024-04-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome With Diarrhea Irritable Bowel Syndrome Mixed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each study subject will undergo two pairs of faecal microbiota transplantation eight weeks apart (a total of four enemas for each patient). Our study design has several specific features: (a) Two consecutive transfers were designed to improve study microbiota engraftment. Before the first of every transfer pairs, the subjects will receive a reduced dose of oral polyethylene glycol for partial bowel preparation. (b) To help discern potential carry-over effects, a placebo-only group was included; this also enables us to assess long-term effects of the intervention. (c) The transferred microbiota is identical throughout the study, having been mixed beforehand, aliquoted and deep frozen. Its alpha diversity was artificially increased by mixing stools from several donors. (d) Placebo is made of the same mixture by careful autoclaving.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

double-blind

Study Groups

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Group A (active microbiota first)

Patients will first receive two enemas of active study microbiota mixture (deep-frozen stored stool microbiota mixed from eight donors in order to increase its diversity), then after eight weeks they will receive two enemas with placebo.

Group Type OTHER

Faecal microbiota transplantation with active study microbiota first

Intervention Type OTHER

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

Group B (inactive microbiota first)

Patients will first receive placebo, then the active study microbiota mixture.

Group Type OTHER

Faecal microbiota transplantation with inactive autoclaved study microbiota first

Intervention Type OTHER

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

Group C (inactive microbiota only)

Patients will receive similarly timed enemas with placebos only.

Group Type OTHER

Faecal microbiota transplantation with inactive autoclaved study microbiota only

Intervention Type OTHER

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

Interventions

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Faecal microbiota transplantation with active study microbiota first

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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
* The use of probiotics within one month prior to faecal microbiota transplantation
* History of inflammatory bowel disease or gastrointestinal malignancy, systemic autoimmune diseases (ongoing or in history)
* Previous abdominal surgery (other than appendectomy or cholecystectomy or hernioplasty or cesarean section)
* HIV infection or other active infection
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No