An interventional study of Fecal transplantation and OTILONII BROMIDUM in Irritable Bowel Syndrome, sponsored by Bogomolets National Medical University. Completed at 2 sites in Ukraine. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Bogomolets National Medical University · Not applicable, Interventional, and Treatment
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 59 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Bogomolets National Medical University is the lead sponsor of 37 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Fecal transplantation of frozen prepared feces from healthy donor. Application by colonoscope in proximal half of colon.
Biological: Fecal transplantation
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
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
OTILONII BROMIDUM , oral, 40 mg TID, 1 months of treatment
Also known as: Spasmomen®
multi-strain probiotic, oral, 1 capsule BID for 1 month
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.
Time frame: at 0, 2, 4 and 12 weeks
assesment of response rate
response rate was assessed as decrease of ≥ 50 points on the IBS-SSS
Time frame: at 12 weeks
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.
Time frame: at 0, 2, 4 and 12 weeks
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.
Time frame: at 0, 2, 4 and 12 weeks
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)
Time frame: at 0 and 1 months
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
Time frame: at 0 and 1 months
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Bogomolets National Medical University