Skip to main content
OpenTrials
Completed

NCT Number: NCT05538026

Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis

Ulcerative colitis (UC) is a chronic immune-mediated inflammatory bowel disease (IBD) that almost always affects the rectum and often extends to the more proximal colon. UC usually begins at a young age (15-30 years), most patients (~ 85%) have a mild or moderate activity, characterized by periods of exacerbation and remission. Considering the important pathogenetic role of gut dysbiosis, recently, as an additional method of treating UC, it is considered a modification of altered gut microbiota using various drug and non-drug methods. One such method is fecal microbiota transplantation (FMT), consisting of the simultaneous replacement of the gut microbiota of a sick recipient with fecal material from a healthy donor. Even though so far the only officially approved indication for FMT is recurrent Clostridium difficile infection, however, the effectiveness of FMT is currently being studied in the treatment of other gastrointestinal and non-gastrointestinal pathologies, including UC. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT in UC, showing encouraging results. This study aimed to assess the clinical and microbiological efficacy, tolerability, and safety of FMT as add-on therapy to basic therapy, in patients with mild-to-moderate UC.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ulcerative Colitis Chronic Mild Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Dysbiosis Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 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 18-60;
  • Endoscopically and morphologically confirmed UC;
  • Negative results of stool culture for the presence of pathogenic bacteria (Shigella spp., Salmonella spp., Campylobacter spp., Yersinia spp.) and toxin-producing Clostridioides difficile;
  • partial Mayo score of 4-6;
  • Mayo endoscopic subscore ≥1;
  • Fecal calprotectin > 150 mcg/g
  • Treatment with mesalazine at a daily dose of 3 g during the last 4 weeks

Exclusion criteria

  • Pregnancy, planning pregnancy or breastfeeding;
  • Postponed operations on the abdominal cavity;
  • Severe mental disorders, alcohol or drug abuse;
  • Use of systemic corticosteroids, biological agents, and probiotics within 8 weeks before study
  • 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

Mesalazine

Drug

daily dose of 3 g (2 g orally + 1 g rectally)

Other names: Pentasa

Fecal transplantation

Biological

Preparation of fresh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of UC patient by colonoscopy after standard bowel preparation.

Primary outcomes

  1. Change in partial Mayo score > 2 points

    Time frame: 8 weeks

    Partial Mayo score composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance. Each part is rated from 0 to 3, giving a total score of 0 to 12. Partial Mayo score (eliminates endoscopy) and of 2 to 4 points indicates mildly active disease, a score of 5 to 6 points indicates moderately active disease, and a score of 7 to 9 points indicates severely active disease

  2. Changes in fecal calprotectin

    Time frame: 8 weeks

    expressed in µg/g

Secondary outcomes

  1. Microbiome profile change

    Time frame: 4 weeks

    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

Efficacy and Safety of Fecal Microbiota Transplantation as add-on Therapy in Patients With Mild-To-Moderate Ulcerative Colitis: A Randomized, Clinical Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2022
Registry last updated
Sep 13, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.