Faecal Microbiota Transplantation in Irritable Bowel Syndrome

NCT04899869 | Completed

• 1 other identifier: INT_TN_001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IBS - D, IBS - M

Outcome Measures

Primary Outcomes (1)

• Change in the IBS severity symptom score (IBS-SSS)

  Change in the IBS severity symptom score (IBS-SSS) in the active microbiota group relative to the placebo group.

  The difference between the score at four weeks after the intervention (study weeks 5 or 13, respectively) and the baseline score (week -1 in 'Active microbiota first' group or week 8 in 'Inactive microbiota first' group)

Secondary Outcomes (14)

• The acute change in the IBS severity symptom score (IBS-SSS)

  study weeks 3 and 11, respectively

• The long-term change in the IBS severity symptom score (IBS-SSS)

  baseline and study week 32

• Change in number of loose stools per day

  baseline and study week 32

• Change in stool consistency

  baseline and study week 32

• Change in abdominal pain

  baseline and study week 32

Study Arms (3)

Group A (active microbiota first)

OTHER

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.

Other: Faecal microbiota transplantation with active study microbiota first

Group B (inactive microbiota first)

OTHER

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

Other: Faecal microbiota transplantation with inactive autoclaved study microbiota first

Group C (inactive microbiota only)

OTHER

Patients will receive similarly timed enemas with placebos only.

Other: Faecal microbiota transplantation with inactive autoclaved study microbiota only

Interventions

Faecal microbiota transplantation with active study microbiota first OTHER

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

Group A (active microbiota first)

Faecal microbiota transplantation with inactive autoclaved study microbiota first OTHER

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

Group B (inactive microbiota first)

Faecal microbiota transplantation with inactive autoclaved study microbiota only OTHER

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

Group C (inactive microbiota only)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomayer University Hospital: lead
• Charles University, Czech Republic: collaborator

Study Sites (1)

Thomayer University Hospital

Prague, 14059, Czechia

Location

Related Publications (1)

• Hurych J, Vejmelka J, Hlinakova L, Kramna L, Larionov V, Kulich M, Cinek O, Kohout P. Protocol for faecal microbiota transplantation in irritable bowel syndrome: the MISCEAT study - a randomised, double-blind cross-over study using mixed microbiota from healthy donors. BMJ Open. 2022 Jun 27;12(6):e056594. doi: 10.1136/bmjopen-2021-056594.

  PMID: 35760542 DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Pavel Kohout

  Thomayer University Hospital, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pavel Kohout, Assoc. Prof., MD, PhD.

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: June 17, 2021
• Primary Completion: March 27, 2024
• Study Completion: April 29, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

CZ (1)