A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a treatment called fecal microbiota transplantation (FMT) and a special diet can help patients with Crohn's disease when combined with advanced therapies. Crohn's disease is a condition that causes inflammation in the digestive tract, and while current treatments help, some patients still experience symptoms. The researchers want to see if adding FMT, which involves transferring healthy gut bacteria from a donor to help restore balance in the intestines, along with a specific diet, can improve treatment outcomes for those who are not responding well to existing therapies.

To participate in this study, patients need to be between 18 and 75 years old and have active Crohn's disease that has not improved with other treatments. They should also meet certain health criteria, like having a specific level of disease activity. Participants will be randomly assigned to different treatment groups, and neither the patients nor the researchers will know which treatment they receive to ensure fair results. Throughout the study, participants can expect regular check-ins and assessments to monitor their health and the effectiveness of the treatments. This research aims to provide new insights and potentially better options for managing Crohn's disease in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with active Crohn disease in whom FMT is feasible
• • 2. Active Crohn's disease who are candidates for advanced therapy (steroid refractory, Immunomodulator intolerant or refractory and moderately severe disease at the time of inclusion) or patients who have an intolerance to or have lost response to advanced therapies must have had their last treatment at least five half-lives prior 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:
• • 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

Trial Officials