Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Group A:Fecal Microbiota
Transplantation (FMT) +anti-
inflammatory diet (AID) + 5-
aminosalicylic acid (ASA)
Group B:Fecal microbiota transplantation with 5-ASA and Sham diet
Group C: A
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with treatment-naive ulcerative colitis of any disease extent. Patients with proctitis will be limited to 25% of the entire pool of patients. 2. Mild to moderate endoscopically active disease (modified Mayo clinic score (mMS) 3-6, with Mayo endoscopic score greater than or equal to 2). 3. Aged between 18-75 years. 4. Patients giving consent for FMT. 5. Patients who agree to adhere to the diet schedule. 6. Patients on oral or topical ASA for less than 4 weeks. 7. Patients on oral steroids/ topical steroids for less than 1 week. 8. Infective colitis should be ruled out by histologic appearance of crypt architecture distortion/basal plasmacytosis, or two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity.
Exclusion criteria
Exclusion criteria: 1. Patients with severe disease (mMS equal to 7-9) 2. Clinical signs of fulminant colitis or toxic megacolon 3. Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns Disease. 4. Patients who have been initiated on other therapies (biologicals or immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate)) for greater than 2 weeks 5. Patients requiring hospitalization 6. Pregnant or lactating women 7. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease. 8. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening# 9. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome will evaluate fecal microbial transplantation or anti-inflammatory diet or combination of both vs placebo for following time points 1. Proportion of patients having clinical remission and endoscopic response at week 10 2. Proportion of patients having clinical remission and endoscopic remission at week 48Timepoint: 10 weeks and 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients having clinical response/ remission; symptomatic response/ remission; endoscopic response/ remission; histologic remission; biomarker remission at week 10 2.Proportion of patients having clinical response/ remission; symptomatic response/ remission; endoscopic response/ remission; histologic remission; biomarker remission at week 48 3.Proportion of patients having adverse events at week 6, 10, 26 and 48 4.Fecal microbiome and metabolite signature between responders and non-responders at baseline, week 10 and week 48 5.Dynamics of microbiome engraftment at week 10 and 48Timepoint: 10 weeks and 48 weeks | — |
Countries
India
Contacts
Public ContactDr Vineet Ahuja
All India Institute of Medical Sciences New Delhi
Outcome results
None listed