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.
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
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
Factorial
Fecal Microbial Transplantation
Other interventionThis will involve colonoscopic instillation of fecal transplant
Sham transplantation
Other interventionSham FMT will involve saline infusion via colonoscopy
Crohns disease exclusion diet
Other interventionThe modified diet plan will be given to each study participant
Sham diet
Other interventionDietary counselling alone
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%).
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)
Proportion of patients with clinical response at Week 10
Proportion of patients with clinical response is defined as either CDAI decrease from baseline of at least 70 points or CDAI less than 150
Proportion of patients with PRO2 Remission at Week 10
Proportion of patients with PRO2 Remission which is defined as Abdominal pain subscore of not more than 1 (on a scale of 0-3) and liquid or very soft stool (Bristol stool scale type 6 or 7) frequency subscore of not more than 3 calculated as a mean of 7 day count
Proportion of patients with endoscopic response at Week 10
Proportion of patients with endoscopic response which is defined as 50% reduction from baseline on SES-CD
Fecal microbiome and metabolite signature between responders and non-responders at week 10
It involves combined analysis of the microorganisms (bacteria, viruses, fungi, etc.) and the small molecules (metabolites) present in a person's stool sample
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All India Institute of Medical Sciences
Lead sponsor
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
