Status:
RECRUITING
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Ulcerative colitis (UC) is a chronic inflammatory disease of the colon characterized by superficial mucosal inflammation. Treatment aims to achieve and maintain remission, improve quality of life, and...
Detailed Description
This study is a multicenter, randomized, factorial-design, double-blind, controlled trial investigating the effects of fecal microbiota transplantation (FMT) and dietary interventions in patients with...
Eligibility Criteria
Inclusion
- Adult (age 18 to 75 years) patients
- Patients with active UC (defined as mMS equal or greater than 3 with rectal bleed score equal or greater than 1 and Endoscopic Mayo score equal or greater than 2 documented within 3 months of randomization or mild symptoms with high inflammatory burden or poor prognostic features).
- Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25 percent of the entire pool of patients.
- Patients with an inadequate response, loss of response, or intolerance to conventional therapies example, aminosalicylates, corticosteroids, immunosuppressants or advanced therapies including but not limited to anti TNF alpha agents, anti-integrins, anti IL 12 or IL 23 agents, anti IL 23 agents, JAK inhibitors, or S1P receptor modulators. The last administration of any such treatment must have occurred at least five half-lives prior to randomization.
- Confirmed diagnosis of UC. The diagnosis must be confirmed by endoscopic and histologic evidence and corroborated by a histopathology report
- Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call and other study procedures
- Subjects who are willing to provide a written informed consent for FMT
- Agree to adhere to the diet schedule
- Infective colitis ruled out Biopsy showing crypt architecture distortion or basal plasmacytosis, OR two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity
Exclusion
- Hospitalization of exacerbation of UC requiring intravenous corticosteroids
- Patients already on biologics (anti-tumor necrosis factor inhibitors) or small molecules (tofacitinib) for equal or more than 2 weeks.
- Clinical signs of fulminant colitis or toxic megacolon
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin or CMV (histology or IHC and or tissue PCR) at screening. (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.)
- Active or inadequately treated infections, including Mycobacterium tuberculosis.
- Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's Disease.
- Patients infected with human immunodeficiency virus (HIV)
- Patients with current or past history of malignancy.
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, Hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- Pregnant females
Key Trial Info
Start Date :
March 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2028
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06906445
Start Date
March 15 2025
End Date
March 15 2028
Last Update
April 2 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, VINEET AHUJA
4
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, India, DR AJIT SOOD