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

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

Interventions

OTHER

Fecal Microbial Transplantation

This will involve colonoscopic instillation of fecal transplant

OTHER

Sham transplantation

Sham FMT will involve saline infusion via colonoscopy

OTHER

Crohns disease exclusion diet

The modified diet plan will be given to each study participant

OTHER

Sham diet

Dietary counselling alone

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh

  collaborator OTHER

• Dayanand Medical College and Hospital

  collaborator OTHER

• Institute of Medical Sciences of the Banaras Hindu University, India

  collaborator OTHER

• Lokmanya Tilak Municipal Medical College and Hospital

  collaborator OTHER

• Lisie Hospital

  collaborator OTHER

• Indraprastha Institute of Information Technology Delhi

  collaborator OTHER

• Indian Council of Medical Research

  collaborator OTHER_GOV

• All India Institute of Medical Sciences

  lead OTHER

Principal Investigators

• Prof Vineet Ahuja, DM Gastroenterology · Department of Gastroenterology, AIIMS, New Delhi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-15

Primary Completion

2027-03-15

Completion

2028-03-15

Countries

• India

Study Locations