Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Group A: Fecal microbiota transplantation and Anti inflammatory diet
Group B: Fecal microbiota transplantation and sham Anti inflammatory diet or standard dietary counselling
Group C: S
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult (age 18 to 75 years) patients 2.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). 3. Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25 percent of the entire pool of patients. 4. 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. 5.Confirmed diagnosis of UC. The diagnosis must be confirmed by endoscopic and histologic evidence and corroborated by a histopathology report 6.Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call and other study procedures 7.Subjects who are willing to provide a written informed consent for FMT 8.Agree to adhere to the diet schedule 9.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 criteria
Exclusion criteria: 1.Hospitalization of exacerbation of UC requiring intravenous corticosteroids 2.Patients already on biologics (anti-tumor necrosis factor inhibitors) or small molecules (tofacitinib) for equal or more than 2 weeks. 3.Clinical signs of fulminant colitis or toxic megacolon 4.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.) 5.Active or inadequately treated infections, including Mycobacterium tuberculosis. 6.Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn s Disease. 7.Patients infected with human immunodeficiency virus (HIV) 8.Patients with current or past history of malignancy. 9.Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, Hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease. 10.Pregnant females
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 & 48 4. Fecal microbiome & metabolite signature at baseline, week 10 & week 48 5. Dynamics of microbiome engraftment at week 10 & 48Timepoint: 10 weeks & 48 weeks | — |
Countries
India
Contacts
Public ContactDr Vineet Ahuja
All India Institute of Medical Sciences
Outcome results
None listed