Actively Recruiting
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis
Led by All India Institute of Medical Sciences · Updated on 2025-04-04
220
Participants Needed
6
Research Sites
156 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 condition affecting the colon and rectum, characterized by mucosal inflammation and symptomslike diarrhea, abdominal pain, and rectal bleeding. It is a subtype of inflammatory bowel disease (IBD) and results from a combination of genetic predisposition, environmental factors, and immune dysregulation. UC is associated with significant gut microbiota dysbiosis, marked by reduced beneficial bacteria and increased harmful taxa. With rising prevalence in developing countries like India, effective and accessible treatments remain a critical need. This multi-center randomized factorial double blind placebo controlled treat through trial will utilize a 2x 2 factorial design to randomize patients of mild to moderate (modified Mayo score 3-6) endoscopically active (Mayo endoscopic score: \>1) treatment naÃive UC in 1:1:1:1 ratio to fecal microbiota transplantation (FMT) + anti-inflammatory diet (AID) +5-aminisalicylic acid (5-ASA) (Intervention, Group A) vs fecal microbiota transplantation + sham diet +5-aminisalicylic acid(Intervention, Group B) vs sham transplantation + anti-inflammatory diet +5-aminisalicylic acid(Intervention, Group C) vs sham transplantation \+ sham diet +5-aminisalicylic acid(Control, Group D). In the induction phase patients will receive FMT/sham transplantation at 0, 2 and 6 weeks along with AID/Sham diet and 5-ASA for 10 weeks. Outcome will be assessed at 10 weeks, Treatment failure will be out of trial. Patients with clinical response at 10 weeks will continue in the maintenance phase and will receive FMT/sham transplantation at 10, 18, 26, 34, and 42 weeks along with AID/Sham diet and 5-ASA till48 weeks. Outcome will be assessed at 48 weeks. Treatment failure will be out of trial. The primary efficacy outcome will evaluate fecal microbial transplantation or anti- inflammatory diet or combination of both vs placebo. The primary outcomes are proportion of patients having clinical remission and endoscopic response at week 10 and proportion of patients having clinical remission and endoscopic remission at week 48. Modified intention to treat analysis will be done and patients who receive at least 1 dose of intervention will be included for outcome assessment.
CONDITIONS
Official 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; proctitis cases limited to 25% of participants
- Mild to moderate active disease with modified Mayo score 3-6 and Mayo endoscopic score 2
- Age between 18 and 75 years
- Consent given for fecal microbiota transplantation (FMT)
- Willingness to follow the assigned diet schedule
- Use of oral or topical 5-aminosalicylic acid (ASA) for less than 4 weeks
- Use of oral or topical steroids for less than 1 week
- Infective colitis ruled out by biopsy or two sigmoidoscopies at least 7 days apart showing active disease
You will not qualify if you...
- Severe disease with modified Mayo score 7-9
- Signs of fulminant colitis or toxic megacolon
- Diagnosis of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or suspected Crohn's disease
- Use of biologicals or immunosuppressants for more than 2 weeks
- Requirement for hospitalization
- Pregnant or lactating women
- Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological diseases
- Positive stool tests for pathogens or Clostridioides difficile toxin at screening
- Infection with human immunodeficiency virus (HIV)
AI-Screening
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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
CONTACT
D
Dr Himanshu Narang, DM Gastroenterology
CONTACT
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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