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

NCT ID: NCT05538026

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-01-10

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.

Conditions

Ulcerative Colitis Chronic Mild; Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard care group

mesalazine (Pentasa) at a daily dose of 3 g (2 g orally + 1 g rectally)

Group Type: ACTIVE_COMPARATOR

Mesalazine

Intervention Type: DRUG

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

Fecal transplantation

Fecal transplantation of fresh prepared feces from healthy donor. Application by colonoscope in proximal half of colon.

Group Type: EXPERIMENTAL

Fecal transplantation

Intervention Type: 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.

Interventions

Mesalazine

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

Intervention Type: DRUG

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Pentasa

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Bogomolets National Medical University

OTHER

Sponsor Role: lead

Responsible Party

Nazarii Kobyliak

Associate Professor, Endocrinology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

Ukraine

References

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.

Reference Type: DERIVED

PMID: 36714101 (View on PubMed)

Other Identifiers

FMT-UC

Identifier Type: -

Identifier Source: org_study_id