FMT for Post-infectious IBS

Irritable Bowel Syndrome Clinical Trial

Official title:

Fecal Microbiota Transplantation in Patients With Post-infection Irritable Bowel Syndrome: a Randomized, Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461833
• Other study ID #: FMT-PI-IBS
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: January 15, 2022

Study information

• Verified date: July 2022
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 15, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Biological:
• 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.

Drug:
• OTILONII BROMIDUM
OTILONII BROMIDUM , oral, 40 mg TID, 1 months of treatment

Dietary Supplement:
• multi-strain probiotic
multi-strain probiotic, oral, 1 capsule BID for 1 month

Locations

Country	Name	City	State
Ukraine	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

Sponsors (2)

Lead Sponsor	Collaborator
Bogomolets National Medical University	Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	assesment of response rate	response rate was assessed as decrease of = 50 points on the IBS-SSS	at 12 weeks
Secondary	Change in BS Quality of Life Scale (IBS-QoL)	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.	at 0, 2, 4 and 12 weeks
Secondary	Change in Fatigue Assessment Scale (FAS)	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.	at 0, 2, 4 and 12 weeks
Secondary	Bacteriology measured in the stool flora by specialized non-culture techniques	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)	at 0 and 1 months
Secondary	Microbiome profile change	Characterization of fecal microbiome by metagenomic analysis before and after intervention Characterization of fecal microbiome by metagenomic analysis before and after intervention	at 0 and 1 months