Actively Recruiting
Efficacy of Microbiome Manipulation Strategies (Fecal Microbial Transplantation or Anti-inflammatory Diet or Both) with 5-aminosalicylic Acid for Induction and Maintenance of Remission in Mild to Moderate Treatment-Naive Active Ulcerative Colitis: A Multicentre Double-blind Factorial Randomized Controlled Trial
Led by All India Institute of Medical Sciences · Updated on 2025-04-04
220
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
All India Institute of Medical Sciences
Lead Sponsor
P
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborating Sponsor
AI-Summary
What this Trial Is About
Ulcerative colitis (UC) is a chronic inflammatory disease affecting the colon and rectum, causing symptoms like diarrhea, abdominal pain, and rectal bleeding. It involves immune system problems and changes in gut bacteria. This research aims to study how fecal microbiota transplantation (FMT) and an anti-inflammatory diet, alone or combined, affect disease activity in patients with mild to moderate active UC who have not received treatment before. The trial is designed as a multi-center, double-blind, randomized study with a 2x2 factorial design to test different treatment combinations alongside standard medication. Participants are randomly assigned to one of four groups: FMT with anti-inflammatory diet plus 5-aminosalicylic acid (5-ASA); FMT with sham diet plus 5-ASA; sham transplantation with anti-inflammatory diet plus 5-ASA; or sham transplantation with sham diet plus 5-ASA. FMT is given via colonoscopy at weeks 0, 2, and 6 during the induction phase, with maintenance doses every 8 weeks up to 48 weeks for responders. The anti-inflammatory diet excludes certain foods and promotes others to support gut health. Sham treatments include sterile water infusions and dietary counseling without changes. During the study, participants undergo clinical evaluations, endoscopy, histology, and laboratory tests at baseline, 10 weeks, and 48 weeks. Researchers assess clinical remission, endoscopic response, and other outcomes to understand treatment effects. Safety is monitored through adverse event reporting. The trial lasts about 48 weeks for each participant, with ongoing assessments of disease activity, gut microbiome changes, and treatment response.
CONDITIONS
Brief Title
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with treatment-naive ulcerative colitis of any disease extent, with proctitis limited to 25% of patients
- Mild to moderate endoscopically active disease (modified Mayo clinic score 3-6, Mayo endoscopic score ≥ 2)
- Aged between 18 and 75 years
- Patients who consent to fecal microbiota transplantation
- Patients willing to adhere to the diet schedule
- Patients on oral or topical 5-aminosalicylic acid for less than 4 weeks
- Patients on oral or topical steroids for less than 1 week
- Infective colitis ruled out by histology or repeat sigmoidoscopies showing endoscopic activity
You will not qualify if you...
- Severe disease (modified Mayo clinic score 7-9)
- Clinical signs of fulminant colitis or toxic megacolon
- Diagnosis of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or Crohn's disease
- Use of biologicals or immunosuppressants for more than 2 weeks
- Requirement for hospitalization
- Pregnant or lactating women
- Severe, progressive, or uncontrolled systemic diseases affecting major organs
- Positive stool tests for pathogens or Clostridioides difficile toxin
- HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive fecal microbiota transplantation or sham transplantation via colonoscopy at weeks 0, 2, and 6, combined with either an anti-inflammatory diet or sham diet. All participants take 5-aminosalicylic acid for 48 weeks.
3 colonoscopy visits during induction (weeks 0, 2, 6) and maintenance sessions every 8 weeks up to week 42 for responders; dietary counseling and monitoring throughout treatment
Duration - Up to 48 weeks
Participants are monitored with clinical evaluations, endoscopy, histology, laboratory tests, and microbiome analysis at weeks 10 and 48 to assess treatment response and safety.
Assessments at week 10 and week 48 including endoscopy and lab tests
Trial Site Locations
Total: 6 locations
1
Department of Gastroenterology, Lisie Hospital
Kochi, Kerala, India
Not Yet Recruiting
2
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra, India
Not Yet Recruiting
3
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
4
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, India
Not Yet Recruiting
5
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research
Chandigarh, Punjab/Haryana, India
Not Yet Recruiting
6
Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University
Varanasi, Uttar Pradesh, India
Not Yet Recruiting
Research Team
P
Prof Vineet Ahuja, DM Gastroenterology
D
Dr Himanshu Narang, DM Gastroenterology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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