FMT for Post-infectious IBS

NCT05461833 | Completed

• 1 other identifier: FMT-PI-IBS
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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

Keywords

Irritable Bowel Syndrome; fecal microbiota transplantation; postinfectious irritable bowel syndrome

Outcome Measures

Primary Outcomes (2)

• Change in Irritable bowel syndrome severity scoring system (IBS-SSS)

  This questionnaire contains five questions, each with a maximum score of 100 using a visual analog scale. Total scores between 75 and 175 were considered indicative of mild IBS severity, 175-300 were moderate, and \>300 were severe.

  at 0, 2, 4 and 12 weeks

• assesment of response rate

  response rate was assessed as decrease of ≥ 50 points on the IBS-SSS

  at 12 weeks

Secondary Outcomes (4)

• Change in BS Quality of Life Scale (IBS-QoL)

  at 0, 2, 4 and 12 weeks

• Change in Fatigue Assessment Scale (FAS)

  at 0, 2, 4 and 12 weeks

• Bacteriology measured in the stool flora by specialized non-culture techniques

  at 0 and 1 months

• Microbiome profile change

  at 0 and 1 months

Study Arms (2)

Fecal transplantation group

EXPERIMENTAL

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

Biological: Fecal transplantation

Standard-care group

ACTIVE COMPARATOR

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

Drug: OTILONII BROMIDUM; Dietary Supplement: multi-strain probiotic

Interventions

Fecal transplantation 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.

Also known as: Fecal microbial transplantation

Fecal transplantation group

OTILONII BROMIDUM DRUG

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

Also known as: Spasmomen®

Standard-care group

multi-strain probiotic DIETARY_SUPPLEMENT

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

Standard-care group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bogomolets National Medical University: lead
• Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine: collaborator

Study Sites (2)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

Location

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

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation; octylonium

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Endocrinology Department

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 18, 2022
• Study Start: September 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 15, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2)