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Completed

NCT Number: NCT05461833

FMT for Post-infectious IBS

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bogomolets National Medical University, Kyiv, Ukraine

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Fecal microbial transplantation

OTILONII BROMIDUM

Drug

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

Other names: Spasmomen®

Multi-strain probiotic

Dietary Supplement

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

Primary outcomes

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

    Time frame: 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.

  2. assesment of response rate

    Time frame: at 12 weeks

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

Secondary outcomes

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

    Time frame: 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.

  2. Change in Fatigue Assessment Scale (FAS)

    Time frame: 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.

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

    Time frame: 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)

  4. Microbiome profile change

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bogomolets National Medical University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 18, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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