Actively Recruiting
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease
Led by All India Institute of Medical Sciences · Updated on 2025-04-04
168
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
Sponsors
A
All India Institute of Medical Sciences
Lead Sponsor
P
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Among the measures of dietary manipulation, the use of exclusive enteral nutrition (EEN) has shown superior, or at least equivalent, efficacy compared with steroids in pediatric CD. Although the results in adults are not as encouraging, recent cohort studies in patients with complicated CD have shown good success rates. Definite exclusion diets that exclude pro-inflammatory dietary constituents have also been tested with good clinical efficacy in patients with CD, who even failed treatment with anti-TNF agents. Various dietary approaches, inclusive of exclusive enteral nutrition, partial enteral nutrition, and Crohn's disease exclusion diet have been reported to be of benefit and are associated with changes in gut microbiome. Fecal microbiota transplantation (FMT) defined as the infusion of fecal suspension from a healthy individual into the gastrointestinal tract of an individual with GI disease carries a diverse population of microbiota and their metabolites and has been tested with varying efficacy in IBD. In general, FMT has shown good success rates in randomized control trials in patients with UC who failed conventional agents. Although limited small RCTs exist in CD, cohort studies have also shown good success rates. Therefore, the use of FMT in addition to standard medical therapy, is a concept that has not been previously explored and forms the basis for the present study. Therefore, a well-powered RCT is required to resolve the role of FMT in CD. In this study, patients will be recruited in four arms. Group A includes FMT+CDED+SMT, in Group B FMT+SMT+SHAM DIET, in Group C Sham FMT+CDED+SMT, in Group D Sham FMT+ Sham Diet+ SMT given. 168 patients will be recruited across 6 centers for around 3 years. Follow-up of the patient will be done at 0,2,6 and 10 weeks and 8 weekly up to 48 weeks.
CONDITIONS
Official Title
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with treatment-naive Crohn's Disease accessible with ileocolonoscopy
- Symptom onset less than 12 months ago
- Mild to moderate disease activity with endoscopically active disease
- Crohn's Disease Activity Index (CDAI) greater than 150 and less than 450
- Simple Endoscopic Score for Crohn's Disease (SES-CD) of 6 or greater (or 4 or greater if isolated ileal disease)
- Age between 18 and 75 years
You will not qualify if you...
- Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization
- Corticosteroids or immunosuppressants treatment for more than 2 weeks
- Prior exposure to biologicals or small molecule drugs
- Presence of stricturing (non-passable stricture), fistulising phenotype, or perianal fistula/abscess
- L4 disease involvement
- Pregnancy or lactation
- Previous surgery for Crohn's Disease
- Declining consent
- Unwillingness to undergo fecal microbiota transplantation or dietary advice
- Current or recent severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease
- Positive stool tests for pathogens or Clostridioides difficile toxin at screening
- HIV infection
AI-Screening
AI-Powered Screening
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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 Gastroentrology, Postgraduate Institute of Medical Education and Research
Chandigarh, Punjab/Haryana, India
Not Yet Recruiting
6
Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University
Varanasi, Uttar Pradesh, India
Not Yet Recruiting
Research Team
P
Prof Vineet Ahuja, DM Gastroenterology
CONTACT
D
Dr Himanshu Narang, DM Gasteroentrology
CONTACT
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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