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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538026
• Other study ID #: FMT-UC
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: January 10, 2022

Study information

• Verified date: September 2022
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 10, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis Chronic Mild

Intervention

Drug:
• Mesalazine
daily dose of 3 g (2 g orally + 1 g rectally)

Biological:
• Fecal transplantation
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.

Locations

Country	Name	City	State
Ukraine	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

Sponsors (2)

Lead Sponsor	Collaborator
Bogomolets National Medical University	Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in fecal calprotectin	expressed in µg/g	8 weeks
Secondary	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	4 weeks