Health Condition 1: K508- Crohns disease of both small andlarge intestine
Conditions
Interventions
Intervention1: Group A: Fecal microbiota transplantation, CDED and advanced therapy
Group B: FMT, sham diet and Advanced therapy
Group C: Advanced-therapy, Sham FMT and CDED
: Group A: Fecal microbio
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with active Crohn disease in whom FMT is feasible 2.Patients with an inadequate response, loss of response, or intolerance to conventional therapies (example, corticosteroids, immunomodulators, methotrexate) 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). The last administration of any such treatment must have occurred at least five half-lives prior to randomization 3.Aged between 18-75 years 4.CDAI greater than 150 and/or SES-CD equal or greater than 6 (or equal or greater than 4 if isolated ileal disease)
Exclusion criteria
Exclusion criteria: 1. Patients in remission (CDAI less than 150) 2. Stricturing disease (non-passable stricture) in whom FMT is not feasible 3. Fistulising phenotype or Perianal fistula or abscess 4. Isolated L4 disease 5. Active TB or Sepsis 6. Pregnant or lactating women 7.Patients with co-morbidities like CAD/CLD/CKD 8. Previous surgery for CD 9. Declining consent or not willing for FMT or diet advice 10. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease. 11.Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening# 12.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 |
|---|---|
| 1.Proportion of patients with clinical remission (CDAI less than 150) and endoscopic response (decline in SES-CD by greater than 50%) at 10 weeks 2.Proportion of patients with clinical remission (CDAI less than 150) and endoscopic remission (SES-CD less than 3) at 48 weeksTimepoint: 10 weeks and 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients with clinical response defined as either CDAI decrease from baseline of at least 70 points or CDAI less than 150 (10 weeks and 48 weeks) 2.Proportion of patients with PRO2 Remission: at 10 weeks and 48 weeks 3.Proportion of patients with endoscopic response defined as 50% reduction from baseline on SES-CD (10 weeks and 48 weeks) 4.Proportion of patients with Endoscopic remission: SES-CD of 2 or less (48 weeks) 5.Proportion of patients with corticosteroid-free clinical remission -those who are in clinical remission at 48 weeks with no exposure to steroids in past 8 weeks (48 weeks) 6.Fecal microbiome and metabolite signature between responders and non-responders at baseline, week 10 and week 48 7.Proportion of patients with biomarker remission 8.Proportion of patients with adverse events at week 6, 10, 26 and 48 Exploratory endpoints 1.Histologic response at 48 weeks Timepoint: 10 weeks and 48 weeks | — |
Countries
India
Contacts
Public ContactDr Vineet Ahuja
All India Institute of Medical Sciences New Delhi
Outcome results
None listed