Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis
Efficacy and Safety of Fecal Microbiota Transplantation as add-on Therapy in Patients With Mild-To-Moderate Ulcerative Colitis: A Randomized, Clinical Trial
1 other identifier
interventional
53
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2022
CompletedFirst Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedSeptember 13, 2022
September 1, 2022
1.3 years
September 9, 2022
September 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in partial Mayo score > 2 points
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
8 weeks
Changes in fecal calprotectin
expressed in µg/g
8 weeks
Secondary Outcomes (1)
Microbiome profile change
4 weeks
Study Arms (2)
standard care group
ACTIVE COMPARATORmesalazine (Pentasa) at a daily dose of 3 g (2 g orally + 1 g rectally)
Fecal transplantation
EXPERIMENTALFecal transplantation of fresh prepared feces from healthy donor. Application by colonoscope in proximal half of colon.
Interventions
daily dose of 3 g (2 g orally + 1 g rectally)
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Bogomolets National Medical University
Kyiv, 01601, Ukraine
Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine
Kyiv, Ukraine
Related Publications (1)
Tkach S, Dorofeyev A, Kuzenko I, Falalyeyeva T, Tsyryuk O, Kovalchuk O, Kobyliak N, Abenavoli L, Boccuto L. Efficacy and safety of fecal microbiota transplantation via colonoscopy as add-on therapy in patients with mild-to-moderate ulcerative colitis: A randomized clinical trial. Front Med (Lausanne). 2023 Jan 12;9:1049849. doi: 10.3389/fmed.2022.1049849. eCollection 2022.
PMID: 36714101DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Endocrinology Department
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 13, 2022
Study Start
September 1, 2020
Primary Completion
January 1, 2022
Study Completion
January 10, 2022
Last Updated
September 13, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share