Ulcerative Colitis Chronic Mild, Inflammatory Bowel Diseases
Conditions
Keywords
Ulcerative Colitis, fecal microbiota transplantation, gut microbiota, dysbiosis, inflammatory bowel disease
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.
Interventions
DRUGMesalazine
daily dose of 3 g (2 g orally + 1 g rectally)
BIOLOGICALFecal 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.
Sponsors
Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine
Bogomolets National Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in partial Mayo score > 2 points | 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 |
| Changes in fecal calprotectin | 8 weeks | expressed in µg/g |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome profile change | 4 weeks | Characterization of fecal microbiome by metagenomic analysis before and after intervention Characterization of fecal microbiome by metagenomic analysis before and after intervention |
Countries
Ukraine
Outcome results
None listed