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New treatment option for Crohn Disease
Official title A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease
ClinicalTrials.gov ID: NCT06890650
What this study is testing
- What it's testing
- 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.
- 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 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
- SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease)
You likely can't join if
- 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
- L4 disease
- Pregnant or lactating women
See the full eligibility criteria
- 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
- SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease)
- Aged between 18-75 years
- 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
- L4 disease
- Pregnant or lactating women
- Previous surgery for CD
- Declining consent
- Not willing for FMT/Dietary advise
- 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...
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
- Chandigarh, Punjab/Haryana, India
- Varanasi, Uttar Pradesh, 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; Chandigarh, Punjab/Haryana, India; Varanasi, Uttar Pradesh, 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.