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New treatment option for Crohns Disease
Official title A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies
ClinicalTrials.gov ID: NCT06890637
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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)
You likely can't join if
- Patients in remission (CDAI less than 150)
- Stricturing disease (non-passable stricture) in whom FMT is not feasible
- Fistulising phenotype or Perianal fistula or abscess
- Isolated L4 disease
- Active TB or Sepsis
- Pregnant or lactating women
See the full eligibility criteria
- 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...
- 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)
- Patients in remission (CDAI less than 150)
- Stricturing disease (non-passable stricture) in whom FMT is not feasible
- Fistulising phenotype or Perianal fistula or abscess
- Isolated L4 disease
- Active TB or Sepsis
- Pregnant or lactating women
- Patients with co-morbidities like CAD/CLD/CKD
- Previous surgery for CD
- Declining consent or not willing for FMT or diet advice
- 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 team makes the final eligibility decision.
Where it's taking place
- Kochi, Kerala, India
- Mumbai, Maharashtra, India
- New Delhi, National Capital Territory of Delhi, India
- Ludhiana, Punjab, India
- Varanasi, Uttar Pradesh, India
- Chandigarh, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kochi, Kerala, India; Mumbai, Maharashtra, India; New Delhi, National Capital Territory of Delhi, India; Ludhiana, Punjab, India; Varanasi, Uttar Pradesh, India; Chandigarh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.