Evaluating fecal transplant and diet changes for Crohn's disease

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

This study is testing whether a fecal transplant and a special diet can help people with newly diagnosed mild to moderate Crohn's disease feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: All India Institute of Medical Sciences (other)
• Drugs / interventions: methotrexate
• Locations: 6 sites (Kochi, Kerala and 5 other locations)
• Trial ID: NCT06890650 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, double-blind, factorial randomized controlled trial aimed at assessing the effectiveness of fecal microbiota transplantation (FMT) and a Crohn's Disease Exclusion Diet (CDED) in patients with newly diagnosed, mild to moderate active Crohn's Disease. Participants will receive either FMT, CDED, both, or sham treatments, with the goal of manipulating the gut microbiome to improve disease activity. The trial involves a structured intervention schedule, including a 3-day course of oral vancomycin prior to FMT and multiple FMT sessions over several weeks. The study is conducted across six centers in India, focusing on treatment-naïve patients with specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are treatment-naïve adults aged 18-75 with mild to moderate active Crohn's disease diagnosed within the last 12 months.

Not a fit: Patients with severe Crohn's disease, those requiring hospitalization, or those who have previously received certain immunosuppressive treatments will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel treatment approach for patients with Crohn's disease, potentially leading to improved disease management and quality of life.

How similar studies have performed: While there have been promising results in similar approaches, this specific combination of FMT and dietary intervention is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Kochi, Kerala and 5 other locations

• 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)

Study contacts

• Principal investigator: Prof Vineet Ahuja, DM Gastroenterology — Department of Gastroenterology, AIIMS, New Delhi
• Study coordinator: Prof Vineet Ahuja, DM Gastroenterology

Conditions: Crohn Disease, Randomized controlled trial, factorial design, Fecal microbiota transplantation, Crohn disease, Crohn disease exclusion diet