Efficacy of Microbiome Manipulation Strategies (Fecal Microbial Transplant or Crohns Disease Exclusion Diet or Both) With Advanced Therapies (BiOlOgics and Small Molecules) to Break the Therapeutic Ceiling in Active Crohns Disease (BOOST-CD): A Multicenter Double Blind Factorial Randomized Controlled Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Advanced therapies including biologics and small molecules target specific inflammatory pathways. IBD's multifactorial etiology means that blocking a single pathway may not be sufficient for all patients. Even when combination of advanced therapies are used, the incremental benefits often diminish, reflecting the therapeutic ceiling. Furthermore, safety concerns also limit the potential to push beyond this ceiling. Increasing the dose or adding more immunosuppressive agents can lead to a higher risk of infections, malignancies, and other adverse effects, making it impractical to continually intensify treatment. Understanding the therapeutic ceiling in IBD highlights the need for innovative approaches that go beyond current strategies. Given the diverse microbial and immunological landscapes in IBD combining fecal microbiota transplantation (FMT) and Crohn's Disease Exclusion Diet (CDED) with advanced therapies represents a promising approach to break the therapeutic ceiling in CD. This strategy leverages the complementary mechanisms of action of FMT/CDED and advance therapies, potentially offering a more comprehensive treatment modality that addresses the complex and multifactorial nature of IBD. FMT involves the transfer of gut microbiota from a healthy donor to a patient, aiming to restore a balanced microbial community in the intestines. This can help modulate the immune system and reduce inflammation, which are central to Crohn's disease pathology. This study seeks to provide evidence on whether addition of microbiota manipulation by FMT and CDED offers additional benefits when used alongside advance therapies in active CD. The findings from this RCT are expected to significantly enhance treatment strategies, ensuring that patients receive the most effective and appropriate care based on robust scientific evidence. This multi-center double blind placebo-controlled RCT will randomize patients in 1:1:1:1 ratio to FMT, CDED and advance therapy vs sham FMT with advance therapy and CDED vs FMT, Advance therapy and sham diet vs Advance therapy with sham FMT and sham diet for induction and maintenance of remission in patients of active Crohn's disease. Randomization will be held centrally to ensure concealment of allocation. Random numbers will be generated by computerized random number schedule (The RAND), and the randomization list and numbered packing of the intervention will be prepared by a person not involved in the study. Randomization will be performed using permuted blocks of 8. Both the patient and the investigator will be blinded to the intervention

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients with active Crohn disease in whom FMT is feasible

• Active Crohn's disease who are candidates for advanced therapy (steroid refractory, Immunomodulator intolerant or refractory and moderately severe disease at the time of inclusion) or patients who have an intolerance to or have lost response to advanced therapies must have had their last treatment at least five half-lives prior randomization.

• Aged between 18-75 years

• CDAI greater than 150 and/or SES-CD equal or greater than 6 (or equal or greater than 4 if isolated ileal disease)

Locations
Other Locations
India
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research
NOT_YET_RECRUITING
Chandigarh
Department of Gastroenterology, Lisie Hospital
NOT_YET_RECRUITING
Kochi
Department of Gastroenterology, Dayanand Medical College
NOT_YET_RECRUITING
Ludhiana
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
NOT_YET_RECRUITING
Mumbai
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
RECRUITING
New Delhi
Department of Gastroenterology, Institute of Medical Sciences
NOT_YET_RECRUITING
Varanasi
Contact Information
Primary
Prof Vineet Ahuja, DM Gastroenterology
vineet.aiims@gmail.com
+91-9810707170
Backup
Dr Himanshu Narang, DM Gasteroentrology
h92narang@gmail.com
+91-8800316504
Time Frame
Start Date: 2025-03-15
Estimated Completion Date: 2028-03-15
Participants
Target number of participants: 168
Treatments
Experimental: Fecal microbiota transplantation(FMT) with Crohns disease exclusion diet (CDED) and advanced therapy
1\. FMT via colonoscopy at 0, 2 and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) 8 weekly during maintenance till 42 weeks 2. Crohn disease exclusion diet(CDED) throughout the study 3. Advanced therapy as standard dose and schedule
Experimental: Fecal microbiota transplantation (FMT) with sham diet and Advanced therapy
1\. FMT via colonoscopy at 0, 2 and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) 8 weekly during maintenance till 42 weeks 2. Dietary counselling throughout the study 3. Advanced therapy as standard dose and schedule
Experimental: Sham FMT with Crohns disease exclusion diet (CDED) and advanced therapy
1\. Sham FMT with instillation of clean water at 0, 2 and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) - 8- weekly during maintenance till 42 weeks 2. CDED throughout the study 3. Advanced therapy as standard dose and schedule
Sham_comparator: Sham Diet with Sham FMT with advance therapy
1.Sham FMT with instillation of clean water at 0, 2 and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) - 8- weekly during maintenance till 42 weeks 2. Dietary counselling throughout the study 3. Advanced therapy as standard dose and schedule.
Sponsors
Leads: All India Institute of Medical Sciences

This content was sourced from clinicaltrials.gov

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