FMT for Post-infectious IBS

NCT ID: NCT05461833

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-01-15

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fecal transplantation group

Fecal transplantation of frozen prepared feces from healthy donor. Application by colonoscope in proximal half of colon.

Group Type: EXPERIMENTAL

Fecal transplantation

Intervention Type: BIOLOGICAL

Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.

Standard-care group

FODMAP diet, Otilonium Bromide, oral, (40mg, 1 tablet TID) and a multi-strain probiotic, oral, (1 capsule BID)

Group Type: ACTIVE_COMPARATOR

OTILONII BROMIDUM

Intervention Type: DRUG

OTILONII BROMIDUM , oral, 40 mg TID, 1 months of treatment

multi-strain probiotic

Intervention Type: DIETARY_SUPPLEMENT

multi-strain probiotic, oral, 1 capsule BID for 1 month

Interventions

Fecal transplantation

Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.

Intervention Type: BIOLOGICAL

OTILONII BROMIDUM

OTILONII BROMIDUM , oral, 40 mg TID, 1 months of treatment

Intervention Type: DRUG

multi-strain probiotic

multi-strain probiotic, oral, 1 capsule BID for 1 month

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Fecal microbial transplantation; Spasmomen®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine

UNKNOWN

Sponsor Role: collaborator

Bogomolets National Medical University

OTHER

Sponsor Role: lead

Responsible Party

Nazarii Kobyliak

Associate Professor, Endocrinology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bogomolets National Medical University

Kyiv, , Ukraine

Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine

Kyiv, , Ukraine

Countries

Ukraine

Other Identifiers

FMT-PI-IBS

Identifier Type: -

Identifier Source: org_study_id