Clinical trial NCT05461833: FMT for Post-infectious IBS
Official title: Fecal Microbiota Transplantation in Patients With Post-infection Irritable Bowel Syndrome: a Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
fecal microbiota transplantation
postinfectious irritable bowel syndrome
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
Collaborators: name: Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine
First posted: 2022-07-18
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Considering that PI-IBS is brought on by infection and gut microbiota may be associated with the onset of symptoms, the modification of altered gut microbiota with nonabsorbable antibiotics such as rifaximin-α or probiotics is often employed as first-stage treatment. Research in recent years has also shown the potential benefits of fecal microbiota transplantation (FMT) for IBS, which is the replacement of a sick recipient's gut microbiota with fecal material from a healthy donor. Even though the only officially approved indication for FMT at this time is recurrent Clostridium difficile infection, the effectiveness of FMT is nevertheless being studied for the treatment of other gastrointestinal and non-gastrointestinal pathologies including IBS. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT for IBS, and most of them have demonstrated positive results. The investigators have not come across studies devoted to the study of the effectiveness of FMT in patients with PI-IBS in the available literature. So, the aim of the current study was to conduct single-centre, randomized clinical trial to assess the safety, clinical and microbiological efficacy of FMT in patients with PI-IBS.


Eligibility criteria: Inclusion Criteria

* age 18-65 years
* PI-IBS diagnosis in accordance with the Rome IV criteria
* moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)
* normal appearing colon on colonoscopy with biopsy that did not reveal pathology
* signed inform consent.

Exclusion Criteria:

* systemic disease, immunodeficiency, or previous treatment with immunomodulators;
* pregnant or breastfeeding;
* previous surgery on the abdominal cavity, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
* severe current disease (hepatic, renal, respiratory, or cardiovascular);
* probiotic or antibiotic use within 8 weeks prior to study initiation;
* any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results.

Primary outcomes:
measure: Change in Irritable bowel syndrome severity scoring system (IBS-SSS)
timeFrame: at 0, 2, 4 and 12 weeks
measure: assesment of response rate
timeFrame: at 12 weeks
Secondary outcomes:
measure: Change in BS Quality of Life Scale (IBS-QoL)
timeFrame: at 0, 2, 4 and 12 weeks
measure: Change in Fatigue Assessment Scale (FAS)
timeFrame: at 0, 2, 4 and 12 weeks
measure: Bacteriology measured in the stool flora by specialized non-culture techniques
timeFrame: at 0 and 1 months
measure: Microbiome profile change
timeFrame: at 0 and 1 months
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets National Medical University
city: Kyiv
country: Ukraine
facility: Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine
Study officials:
References: