A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease

NCT06890650 | Recruiting DMC

• 2 other identifiers: AIIMSA2989/03.01.2025EMDR/CARE/12/2023-0000572
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 6

Brief Summary

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

Crohn Disease

Keywords

Randomized controlled trial; factorial design; Fecal microbiota transplantation; Crohn disease; Crohn disease exclusion diet

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with clinical remission and endoscopic response at week 10

  Proportion of patients with clinical remission (defined as CDAI less than 150) and endoscopic response( defined decline in SES-CD by gretaer than 50%).

  10 weeks

• Proportion of patients with clinical remission and endoscopic remission at week 48

  Proportion of patients with clinical remission (defined as Crohn's disease activity index less than 150) and endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease patients less than 3)

  48 weeks

Secondary Outcomes (16)

• Proportion of patients with clinical response at Week 10

  10 weeks

• Proportion of patients with PRO2 Remission at Week 10

  10 weeks

• Proportion of patients with endoscopic response at Week 10

  10 weeks

• Fecal microbiome and metabolite signature between responders and non-responders at week 10

  10 weeks

• Proportion of patients with biomarker remission at Week 10

  10 weeks

Study Arms (4)

Fecal Microbiota Transplantation(FMT) with Crohns disease exclusion diet(CDED)

EXPERIMENTAL

1\. Oral vancomycin 500 mg BD for 3 days before first FMT 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 48 weeks

Other: Fecal Microbial Transplantation; Other: Crohns disease exclusion diet

Fecal microbiota transplantation(FMT) and sham diet

EXPERIMENTAL

1\. Oral vancomycin 500 mg BD for 3 days before first FMT 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 10 weeks and then 8 weekly during maintenance between 10 to 42 weeks 3. Diet counselling for 48 weeks

Other: Fecal Microbial Transplantation; Other: Sham diet

Crohns Disease Exclusion Diet(CDED) and sham transplantation

EXPERIMENTAL

1\. Oral placebo 1 BD for 3 days before first FMT 2. Sham transplantation (clean water) via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 48 weeks 3.Crohns Disease Exclusion Diet for 48 weeks

Other: Sham transplantation; Other: Crohns disease exclusion diet

Sham transplantation with Sham diet

SHAM COMPARATOR

1.Oral placebo 1 BD for 3 days before first sham transplantation 2. Sham colonoscopy with instillation of saline at 0, 2, and 6 weeks followed by (if treatment responder) - 8-weekly during maintenance between 10 to 48 weeks

Other: Sham transplantation; Other: Sham diet

Interventions

Fecal Microbial Transplantation OTHER

This will involve colonoscopic instillation of fecal transplant

Fecal Microbiota Transplantation(FMT) with Crohns disease exclusion diet(CDED); Fecal microbiota transplantation(FMT) and sham diet

Sham transplantation OTHER

Sham FMT will involve saline infusion via colonoscopy

Crohns Disease Exclusion Diet(CDED) and sham transplantation; Sham transplantation with Sham diet

Crohns disease exclusion diet OTHER

The modified diet plan will be given to each study participant

Crohns Disease Exclusion Diet(CDED) and sham transplantation; Fecal Microbiota Transplantation(FMT) with Crohns disease exclusion diet(CDED)

Sham diet OTHER

Dietary counselling alone

Fecal microbiota transplantation(FMT) and sham diet; Sham transplantation with Sham diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• CDAI of greater than 150 and less than 450
• SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease)
• Aged between 18-75 years

You may not qualify if:

• Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization
• Patients who have been received on corticosteroids, immunosuppressants (azathioprine/ 6- mercaptoprine/methotrexate) for greater than 2 weeks
• Biologicals or small molecule exposure
• Stricturing (non-passable stricture), fistulising phenotype or perianal fistula/abscess
• L4 disease
• Pregnant or lactating women
• Previous surgery for CD
• Declining consent
• Not willing for FMT/Dietary advise
• Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
• Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator
• Dayanand Medical College and Hospital: collaborator
• Institute of Medical Sciences of the Banaras Hindu University, India: collaborator
• Lokmanya Tilak Municipal Medical College and Hospital: collaborator
• Lisie Hospital: collaborator
• Indraprastha Institute of Information Technology Delhi: collaborator
• Indian Council of Medical Research: collaborator

Study Sites (6)

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

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Prof Vineet Ahuja, DM Gastroenterology

  Department of Gastroenterology, AIIMS, New Delhi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Vineet Ahuja, DM Gastroenterology

CONTACT

+91-9810707170; vineet.aiims@gmail.com

Dr Himanshu Narang, DM Gasteroentrology

CONTACT

+91-8800316504; h92narang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 24, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2028
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)