Actively Recruiting
Efficacy of Microbiome Manipulation Strategies (Fecal Microbial Transplant or Crohn's Disease Exclusion Diet or Both) with Advanced Therapies (Biologics and Small Molecules) to Break the Therapeutic Ceiling in Active Crohn's Disease: A Multicenter Double-Blind Factorial Randomized Controlled Trial
Led by All India Institute of Medical Sciences · Updated on 2025-04-04
168
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new ways to improve treatment for active Crohn's Disease (CD), a complex inflammatory bowel condition. This study focuses on whether combining advanced therapies like biologics and small molecules with microbiome-based treatments—fecal microbiota transplantation (FMT) and a special diet called Crohn's Disease Exclusion Diet (CDED)—can overcome the limits of current treatments. The trial is a multicenter, double-blind, randomized controlled study designed to provide strong scientific evidence on these combined approaches. Participants in the study will be assigned to one of four groups receiving different combinations of treatments: FMT via colonoscopy at specified weeks, CDED diet, sham FMT (using sterile water), or sham diet counseling, all alongside standard advanced therapies. FMT is given during an induction phase (weeks 0, 2, and 6) and, for responders, every eight weeks during maintenance up to week 42. The CDED involves eliminating certain pro-inflammatory foods initially, then gradually reintroducing some foods during maintenance. Sham treatments mimic the procedures without the active components, ensuring the study remains double-blinded. Throughout the study, participants will undergo regular assessments including clinical activity scores, symptom tracking, blood and stool tests, endoscopic evaluations, and microbiome analysis. Visits occur frequently during induction and maintenance phases, with safety monitoring before and after FMT sessions. The main outcomes measured are the rates of clinical remission and endoscopic response at weeks 10 and 48. This comprehensive approach aims to understand how these combined therapies affect disease activity and patient health over nearly a year of follow-up.
CONDITIONS
Brief Title
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with active Crohn's Disease suitable for fecal microbiota transplantation
- Candidates for advanced therapy (steroid refractory, immunomodulator intolerant or refractory, or moderately severe disease)
- Patients intolerant to or who have lost response to advanced therapies, with last treatment at least five half-lives before randomization
- Aged between 18 and 75 years
- Crohn's Disease Activity Index (CDAI) greater than 150 and/or Simple Endoscopic Score for Crohn's Disease (SES-CD) equal to or greater than 6, or equal to or greater than 4 if isolated ileal disease
You will not qualify if you...
- Patients in remission (CDAI less than 150)
- Stricturing disease with non-passable stricture where fecal microbiota transplantation is not feasible
- Fistulizing phenotype, perianal fistula, or abscess
- Isolated L4 disease
- Active tuberculosis or sepsis
- Pregnant or lactating women
- Patients with co-morbidities such as coronary artery disease, chronic liver disease, or chronic kidney disease
- Previous surgery for Crohn's Disease
- Declining consent or unwillingness to undergo fecal microbiota transplantation or dietary advice
- Patients with severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological diseases
- Positive tests for pathogens or Clostridioides difficile toxin at screening
- Patients infected with human immunodeficiency virus (HIV)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 42 weeks
Participants receive fecal microbiota transplantation or sham transplantation via colonoscopy at weeks 0, 2, and 6, along with either the Crohn's Disease Exclusion Diet or sham diet, and continue advanced therapy. Responders continue maintenance FMT or sham every 8 weeks up to week 42, alongside ongoing dietary intervention and advanced therapy.
Visits at weeks 0, 2, 4, 6, 10, then every 8 weeks until week 48
Duration - Up to 48 weeks
Participants are monitored with clinical assessments, endoscopy, diet adherence checks, stool microbiome sampling, and safety evaluations up to week 48 after completion of treatment interventions.
Clinical and diet adherence assessments at weeks 10, 18, 26, 34, 42, and 48; endoscopy and stool sample collection at weeks 10 and 48
Trial Site Locations
Total: 6 locations
1
Department of Gastroenterology, Lisie Hospital
Kochi, Kerala, India
Not Yet Recruiting
2
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra, India
Not Yet Recruiting
3
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Actively Recruiting
4
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, India
Not Yet Recruiting
5
Department of Gastroenterology, Institute of Medical Sciences
Varanasi, Uttar Pradesh, India
Not Yet Recruiting
6
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research
Chandigarh, India
Not Yet Recruiting
Research Team
P
Prof Vineet Ahuja, DM Gastroenterology
D
Dr Himanshu Narang, DM Gasteroentrology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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