A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies
Not applicable · Testing Fecal Microbial Transplantation, Crohns Disease Exclusion Diet and Advanced therapy · 6 sites · All India Institute of Medical Sciences
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal Microbial Transplantation, Crohns Disease Exclusion Diet and Advanced therapy as a possible treatment. Condition(s) listed: Crohns Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
- Aged between 18-75 years
Plus 1 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 168 participants are expected to take part.
- Start date: 2025-03-15.
- Main results expected around 2027-03-15 (estimate from the record).
- 6 study sites listed (1 marked recruiting) in India.
Main thing being measured
- Proportion of patients with clinical remission and endoscopic response at week 10 (10 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohns Disease |
| Lead sponsor | All India Institute of Medical Sciences |
| Enrollment | 168 (estimated) |
| Start date | 2025-03-15 |
| Primary completion (est.) | 2027-03-15 |
| First posted | 2025-03-24 |
| Last updated | 2025-04-04 |
| Official title | Efficacy of Microbiome Manipulation Strategies (Fecal Microbial Transplant or Crohns Disease Exclusion Diet or Both) With Advanced Therapies (BiOlOgics and Small Molecules) to Break the Therapeutic Ceiling in Active Crohns Disease (BOOST-CD): A Multicenter Double Blind Factorial Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT06890637 |
Interventions
- Fecal Microbial Transplantation (Other)
This will involve colonoscopic instillation of fecal transplant - Crohns Disease Exclusion Diet (Other)
The modified diet plan will be given to each study participant - Sham transplantation (Other)
Sham transplantation will involve saline infusion via colonoscopy - Sham Diet (Other)
Dietary counselling alone - Advanced therapy (Other)
Advanced therapy as standard dose and schedule
Full eligibility criteria (from the record)
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
Locations (6)
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastroentrology, Postgraduate Institute of Medical Education and Research | Chandigarh | India | Not yet recruiting |
| Department of Gastroenterology, Lisie Hospital | Kochi, Kerala | India | Not yet recruiting |
| Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion | Mumbai, Maharashtra | India | Not yet recruiting |
| Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences | New Delhi, National Capital Territory of Delhi | India | Recruiting |
| Department of Gastroenterology, Dayanand Medical College | Ludhiana, Punjab | India | Not yet recruiting |
| Department of Gastroenterology, Institute of Medical Sciences | Varanasi, Uttar Pradesh | India | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.