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New treatment option for Ulcerative Colitis (UC)
Official title A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT06895252
What this study is testing
- What it's testing
- Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and rectum, characterized by mucosal inflammation and symptomslike diarrhea, abdominal pain, and rectal bleeding. It is a subtype of inflammatory bowel disease (IBD) and results from a combination of genetic predisposition, environmental factors, and immune dysregulation.
- 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 ulcerative colitis of any disease extent. Patients with proctitis will be limited to 25% of the entire pool of patients.
- Mild to moderate endoscopically active disease (modified Mayo clinic score (mMS) 3-6, with Mayo endoscopic score greater than or equal to 2).
- Aged between 18-75 years.
- Patients giving consent for FMT.
- Patients who agree to adhere to the diet schedule.
You likely can't join if
- Patients with severe disease (mMS equal to 7-9)
- Clinical signs of fulminant colitis or toxic megacolon
- Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns Disease.
- Patients who have been initiated on other therapies (biologicals or immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate)) for greater than...
- Patients requiring hospitalization
- Pregnant or lactating women
See the full eligibility criteria
- Patients with treatment-naive ulcerative colitis of any disease extent. Patients with proctitis will be limited to 25% of the entire pool of patients.
- Mild to moderate endoscopically active disease (modified Mayo clinic score (mMS) 3-6, with Mayo endoscopic score greater than or equal to 2).
- Aged between 18-75 years.
- Patients giving consent for FMT.
- Patients who agree to adhere to the diet schedule.
- Patients on oral or topical ASA for less than 4 weeks.
- Patients on oral steroids/ topical steroids for less than 1 week.
- Infective colitis should be ruled out by histologic appearance of crypt architecture distortion/basal plasmacytosis, or two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity.
- Patients with severe disease (mMS equal to 7-9)
- Clinical signs of fulminant colitis or toxic megacolon
- Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns Disease.
- Patients who have been initiated on other therapies (biologicals or immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate)) for greater than 2 weeks
- Patients requiring hospitalization
- Pregnant or lactating women
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, haematological, 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.
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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.