Health Condition 1: K508- Crohns disease of both small andlarge intestine
Conditions
Interventions
Intervention1: Group A:Fecal Microbiota Transplantation(FMT)+ Crohns disease exclusion diet(CDED)
Group B: Fecal microbiota transplantation and diet counselling
Group C: Crohns Disease Exclusion Diet
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with treatment-naive Crohns disease accessible with ileocolonoscopy 2. Symptom onset of less than 12 months 3. Mild to moderate disease activity with endoscopically active disease a. CDAI of greater than 150 and less than 450 b. SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease) 4. Aged between 18-75 years
Exclusion criteria
Exclusion criteria: 1.Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization 2. Patients who have been received on corticosteroids, immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate) for greater than 2 weeks 3. Biologicals or small molecule exposure 4. Stricturing (non-passable stricture), fistulising phenotype or perianal fistula/abscess 5. L4 disease 6. Pregnant or lactating women 7. Previous surgery for CD 8. Declining consent 9. Not willing for FMT/Dietary advise 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 gretaer 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 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.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