Status:
RECRUITING
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease
Lead Sponsor:
All India Institute of Medical Sciences
Collaborating Sponsors:
Post Graduate Institute of Medical Education and Research, Chandigarh
Dayanand Medical College and Hospital
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Dysbiosis can be rectified by several methods: antibiotics, prebiotics, probiotics, dietary modulation, and fecal microbiota transplantation. There has been limited success with the isolated use of an...
Detailed Description
This study is a multi-center, double-blind, factorial randomized controlled trial designed to evaluate the efficacy of microbiome manipulation strategies using fecal microbiota transplantation (FMT), ...
Eligibility Criteria
Inclusion
- Patients with treatment-naive Crohns disease accessible with ileocolonoscopy
- Symptom onset of less than 12 months
- Mild to moderate disease activity with endoscopically active disease
- CDAI of greater than 150 and less than 450
- SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease)
- Aged between 18-75 years
Exclusion
- Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization
- Patients who have been received on corticosteroids, immunosuppressants (azathioprine/ 6- mercaptoprine/methotrexate) for greater than 2 weeks
- Biologicals or small molecule exposure
- Stricturing (non-passable stricture), fistulising phenotype or perianal fistula/abscess
- L4 disease
- Pregnant or lactating women
- Previous surgery for CD
- Declining consent
- Not willing for FMT/Dietary advise
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
- Patients infected with human immunodeficiency virus (HIV) # The patients with positive assay will be treated appropriately and tests will be repeated. Those with negative assay and persistent activity will be included in the study.
Key Trial Info
Start Date :
March 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2028
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06890650
Start Date
March 15 2025
End Date
March 15 2028
Last Update
April 4 2025
Active Locations (6)
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1
Department of Gastroenterology, Lisie Hospital
Kochi, Kerala, India
2
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra, India
3
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
4
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, India