A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies
Recruiting · NCT06890637 · Interventional (participants receive a specific treatment) · Lead sponsor: All India Institute of Medical Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Advanced therapies including biologics and small molecules target specific inflammatory pathways. IBD's multifactorial etiology means that blocking a single pathway may not be sufficient for all patients. Even when combination of advanced therapies are used, the incremental benefits often diminish, reflecting the therapeutic ceiling. Furthermore, safety concerns also limit the potential to push beyond this ceiling. Increasing the dose or adding more immunosuppressive agents can lead to a higher risk of infections, malignancies, and other adverse effects, making it impractical to continually intensify treatment. Understanding the therapeutic ceiling in IBD highlights the need for innovative approaches that go beyond current strategies. Given the diverse microbial and immunological landscapes in IBD combining fecal microbiota transplantation (FMT) and Crohn's Disease Exclusion Diet (CDED) with advanced therapies represents a promising approach to break the therapeutic ceiling in CD. This strategy leverages the complementary mechanisms of action of FMT/CDED and advance therapies, potentially offering a more comprehensive treatment modality that addresses the complex and multifactorial nature of IBD. FMT involves the transfer of gut microbiota from a healthy donor to a patient, aiming to restore a balanced microbial community in the intestines. This can help modulate the immune system and reduce inflammation, which are central to Crohn's disease pathology. This study seeks to provide evidence on whether addition of microbiota manipulation by FMT and CDED offers additional benefits when used alongside advance therapies in active CD. The findings from this RCT are expected to significantly enhance treatment strategies, ensuring that patients receive the most effective and appropriate care based on robust scientific evidence. This multi-center double blind placebo-controlled RCT will randomize patients in 1:1:1:1 ratio to FMT, CDED and advance therapy vs sham FMT with advance therapy and CDED vs FMT, Advance therapy and sham diet vs Advance therapy with sham FMT and sham diet for induction and maintenance of remission in patients of active Crohn's disease. Randomization will be held centrally to ensure concealment of allocation. Random numbers will be generated by computerized random number schedule (The RAND), and the randomization list and numbered packing of the intervention will be prepared by a person not involved in the study. Randomization will be performed using permuted blocks of 8. Both the patient and the investigator will be blinded to the intervention
Who can take part
Inclusion criteria
- Patients with active Crohn disease in whom FMT is feasible
- 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.
- Aged between 18-75 years
- 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
- Patients in remission (CDAI less than 150)
- Stricturing disease (non-passable stricture) in whom FMT is not feasible
- Fistulising phenotype or Perianal fistula or abscess
- Isolated L4 disease
- Active TB or Sepsis
- Pregnant or lactating women
- Patients with co-morbidities like CAD/CLD/CKD
- Previous surgery for CD
- Declining consent or not willing for FMT or diet advice
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
- 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
Where it is running
6 locations listed.
- Department of Gastroentrology, Postgraduate Institute of Medical Education and Research - Chandigarh, India
- Department of Gastroenterology, Lisie Hospital - Kochi, Kerala, India
- Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion - Mumbai, Maharashtra, India
- Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences - New Delhi, National Capital Territory of Delhi, India
- Department of Gastroenterology, Dayanand Medical College - Ludhiana, Punjab, India
- Department of Gastroenterology, Institute of Medical Sciences - Varanasi, Uttar Pradesh, India