A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease

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

Keywords

ClinConnect Summary

This clinical trial is looking at how fecal transplants, combined with specific dietary changes, can help people with newly diagnosed active Crohn's disease, which is a type of inflammatory bowel disease (IBD). The study will involve 168 participants who have had symptoms for less than a year and have mild to moderate disease activity. Eligible participants must be between 18 and 75 years old and should not have received certain medications like steroids or immunosuppressants for more than two weeks.

Participants in the study will be divided into different groups to receive various treatments, including fecal transplants and special diets, over about three years. They will have regular check-ups at 0, 2, 6, and 10 weeks, and then every eight weeks for up to 48 weeks to monitor their progress. This trial is important because it aims to explore a new treatment approach for Crohn's disease that hasn't been thoroughly studied before, which could offer hope for better management of this challenging condition.

Gender

ALL

Eligibility 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
• • 1. CDAI of greater than 150 and less than 450
• • 2. 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:
• • 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.