Crohn'sRecruiting
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease
Not applicable · Testing Fecal Microbial Transplantation and Crohns disease exclusion diet · 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 and Crohns disease exclusion diet as a possible treatment. Condition(s) listed: Crohn 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 treatment-naive Crohns disease accessible with ileocolonoscopy
- Symptom onset of less than 12 months
- Mild to moderate disease activity with endoscopically active disease
Plus 3 more requirement(s). There are also 12 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
Dysbiosis can be rectified by several methods: antibiotics, prebiotics, probiotics, dietary modulation, and fecal microbiota transplantation. There has been limited success with the isolated use of antibiotics and pre/probiotics in the treatment of IBD.
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 | Crohn Disease |
| Lead sponsor | All India Institute of Medical Sciences |
| Collaborators | Post Graduate Institute of Medical Education and Research, Chandigarh; Dayanand Medical College and Hospital; Institute of Medical Sciences of the Banaras Hindu University, India; Lokmanya Tilak Municipal Medical College and Hospital; Lisie Hospital; Indraprastha Institute of Information Technology Delhi; Indian Council of Medical Research |
| 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 Transplantation OR CDED OR Both) in Combination Standard Medical Therapy for Induction and Maintenance of Remission in Mild to Moderate tReatment naÃive Active Crohns Disease (ALTER-CD): a Multicentre Double-blind Factorial Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT06890650 |
Interventions
- Fecal Microbial Transplantation (Other)
This will involve colonoscopic instillation of fecal transplant - Sham transplantation (Other)
Sham FMT will involve saline infusion via colonoscopy - Crohns disease exclusion diet (Other)
The modified diet plan will be given to each study participant - Sham diet (Other)
Dietary counselling alone
Full eligibility criteria (from the record)
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.
Locations (6)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 Gastroentrology, Postgraduate Institute of Medical Education and Research | Chandigarh, Punjab/Haryana | India | Not yet recruiting |
| Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University | 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.