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New treatment option for Ulcerative Colitis
Official title A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies
ClinicalTrials.gov ID: NCT06906445
What this study is testing
- What it's testing
- Ulcerative colitis (UC) is a chronic inflammatory disease of the colon characterized by superficial mucosal inflammation. Treatment aims to achieve and maintain remission, improve quality of life, and minimize complications.
- 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
- Adult (age 18 to 75 years) patients
- Patients with active UC (defined as mMS equal or greater than 3 with rectal bleed score equal or greater than 1 and Endoscopic Mayo score equal or...
- Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25 percent of the entire pool of patients.
- Patients with an inadequate response, loss of response, or intolerance to conventional therapies example, aminosalicylates, corticosteroids...
- Confirmed diagnosis of UC. The diagnosis must be confirmed by endoscopic and histologic evidence and corroborated by a histopathology report
You likely can't join if
- Hospitalization of exacerbation of UC requiring intravenous corticosteroids
- Patients already on biologics (anti-tumor necrosis factor inhibitors) or small molecules (tofacitinib) for equal or more than 2 weeks.
- Clinical signs of fulminant colitis or toxic megacolon
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin or CMV...
- Active or inadequately treated infections, including Mycobacterium tuberculosis.
- Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's Disease.
See the full eligibility criteria
- Adult (age 18 to 75 years) patients
- Patients with active UC (defined as mMS equal or greater than 3 with rectal bleed score equal or greater than 1 and Endoscopic Mayo score equal or greater than 2 documented within 3 months of randomization or mild...
- Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25 percent of the entire pool of patients.
- Patients with an inadequate response, loss of response, or intolerance to conventional therapies example, aminosalicylates, corticosteroids, immunosuppressants or advanced therapies including but not limited to anti TNF...
- Confirmed diagnosis of UC. The diagnosis must be confirmed by endoscopic and histologic evidence and corroborated by a histopathology report
- people who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call and other study procedures
- people who are willing to provide a written informed consent for FMT
- Agree to adhere to the diet schedule
- Infective colitis ruled out Biopsy showing crypt architecture distortion or basal plasmacytosis, OR two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity
- Hospitalization of exacerbation of UC requiring intravenous corticosteroids
- Patients already on biologics (anti-tumor necrosis factor inhibitors) or small molecules (tofacitinib) for equal or more than 2 weeks.
- Clinical signs of fulminant colitis or toxic megacolon
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin or CMV (histology or IHC and or tissue PCR) at screening. (The patients with...
- Active or inadequately treated infections, including Mycobacterium tuberculosis.
- Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's Disease.
- Patients infected with human immunodeficiency virus (HIV)
- Patients with current or past history of malignancy.
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, Hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- Pregnant females
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.