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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
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.
OTILONII BROMIDUM , oral, 40 mg TID, 1 months of treatment
multi-strain probiotic, oral, 1 capsule BID for 1 month
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
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
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