CompletedNot Applicable

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Czechia61 participantsStarted 2021-06-17

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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)

Trial details

NCT IDNCT04899869

SponsorThomayer University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-27

View on ClinicalTrials.gov More Irritable Bowel Syndrome With Diarrhea trials