Faecal Microbiota Transplantation in Irritable Bowel Syndrome (MISCEAT)

Thomayer University Hospital

Status: Completed

Conditions: Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome Mixed

Treatments: Other: Faecal microbiota transplantation with active study microbiota first; Other: Faecal microbiota transplantation with inactive autoclaved study microbiota only; Other: Faecal microbiota transplantation with inactive autoclaved study microbiota first

Study type: Interventional

Funder types: Other

Identifiers

NCT04899869

INT_TN_001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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61 participants in 3 patient groups

Group A (active microbiota first)

Other group

Description:

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.

Treatment:

Other: Faecal microbiota transplantation with active study microbiota first

Group B (inactive microbiota first)

Other group

Description:

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

Treatment:

Other: Faecal microbiota transplantation with inactive autoclaved study microbiota first

Group C (inactive microbiota only)

Other group

Description:

Patients will receive similarly timed enemas with placebos only.

Treatment:

Other: Faecal microbiota transplantation with inactive autoclaved study microbiota only