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

RecruitingNAAges 18 Years - 75 YearsAllAll India Institute of Medical Sciences
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Fecal Microbial Transplantation
  • Crohns Disease Exclusion Diet
  • Sham transplantation
  • Sham Diet
  • Advanced therapy
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Where

6 sites
Department of Gastroenterology, Lisie Hospital
Kochi, India
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, India
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, India
Department of Gastroenterology, Dayanand Medical College
Ludhiana, India
Department of Gastroenterology, Institute of Medical Sciences
Varanasi, India
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research
Chandigarh, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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