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Study identifier: NCT06890637 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies

Condition: Crohns Disease  ·  Sponsor: All India Institute of Medical Sciences

PhaseNA
Planned participants168
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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 pro…

This description comes directly from the study's public registry record.

Talk to the study team

Prof Vineet Ahuja, DM Gastroenterology  ·  +91-9810707170  ·  vineet.aiims@gmail.com

Dr Himanshu Narang, DM Gasteroentrology  ·  +91-8800316504  ·  h92narang@gmail.com

Always discuss trial participation with your own doctor first.

Locations (6)

Department of Gastroenterology, Lisie HospitalKochi, Kerala, IndiaNot Yet Recruiting
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, SionMumbai, Maharashtra, IndiaNot Yet Recruiting
Department of Gastroenterology and Human Nutrition, All India Institute of Medical SciencesNew Delhi, National Capital Territory of Delhi, IndiaRecruiting
Department of Gastroenterology, Dayanand Medical CollegeLudhiana, Punjab, IndiaNot Yet Recruiting
Department of Gastroenterology, Institute of Medical SciencesVaranasi, Uttar Pradesh, IndiaNot Yet Recruiting
Department of Gastroentrology, Postgraduate Institute of Medical Education and ResearchChandigarh, IndiaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06890637