FMT for Post-infectious IBS

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: OTILONII BROMIDUM; Biological: Fecal transplantation; Dietary Supplement: multi-strain probiotic

• Registration Number: NCT05461833
• Lead Sponsor: Bogomolets National Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-15
• Status Verified: 2022-07
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-18
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-care group	OTILONII BROMIDUM	FODMAP diet, Otilonium Bromide, oral, (40mg, 1 tablet TID) and a multi-strain probiotic, oral, (1 capsule BID)
Standard-care group	multi-strain probiotic	FODMAP diet, Otilonium Bromide, oral, (40mg, 1 tablet TID) and a multi-strain probiotic, oral, (1 capsule BID)
Fecal transplantation group	Fecal transplantation	Fecal transplantation of frozen prepared feces from healthy donor. Application by colonoscope in proximal half of colon.

Primary Outcome Measures

Name	Time	Method
Change in Irritable bowel syndrome severity scoring system (IBS-SSS)	at 0, 2, 4 and 12 weeks	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.
assesment of response rate	at 12 weeks	response rate was assessed as decrease of ≥ 50 points on the IBS-SSS

Secondary Outcome Measures

Name	Time	Method
Change in BS Quality of Life Scale (IBS-QoL)	at 0, 2, 4 and 12 weeks	This questionnaire contains 34 items concerning the physical and psychological functioning of IBS patients in 8 domains: dysphoria, activity interference, body image, health concerns, food avoidance, social reactions, sexual function and impact on relationships.
Bacteriology measured in the stool flora by specialized non-culture techniques	at 0 and 1 months	The percentage of patients in each group were evaluated and characterized by a decrease below the normal content of symbiotic bacteria Bifidobacterium (less than 107 CFU / g), lactobacilli (less than 107 CFU / d), E.coli with normal properties (less than 106 CFU / d) and increase in content E.coli with altered properties (more than 106 CFU / g), pathogenic enterobacteria (not normally detected) and fungi of the genus Candida (more than 104 CFU / d)
Microbiome profile change	at 0 and 1 months	Characterization of fecal microbiome by metagenomic analysis before and after intervention Characterization of fecal microbiome by metagenomic analysis before and after intervention
Change in Fatigue Assessment Scale (FAS)	at 0, 2, 4 and 12 weeks	The questionnaire comprises 10 questions with 5-point-scale answers varying from never to always. Five of these questions measured physical fatigue and the other five measured mental fatigue.

Trial Locations

Locations (2)

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