Phase
Condition
Ulcerative Colitis
Crohn's Disease
Bowel Dysfunction
Treatment
Sham transplantation
Advanced Therapy
Fecal Microbial Transplantation
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult (age 18 to 75 years) patients
Patients with active UC (defined as mMS equal or greater than 3 with rectal bleedscore equal or greater than 1 and Endoscopic Mayo score equal or greater than 2documented within 3 months of randomization or mild symptoms with high inflammatoryburden or poor prognostic features).
Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25percent of the entire pool of patients.
Patients with an inadequate response, loss of response, or intolerance toconventional therapies example, aminosalicylates, corticosteroids,immunosuppressants or advanced therapies including but not limited to anti TNF alphaagents, anti-integrins, anti IL 12 or IL 23 agents, anti IL 23 agents, JAKinhibitors, or S1P receptor modulators. The last administration of any suchtreatment must have occurred at least five half-lives prior to randomization.
Confirmed diagnosis of UC. The diagnosis must be confirmed by endoscopic andhistologic evidence and corroborated by a histopathology report
Subjects who are willing and able to comply with treatment plan, laboratory tests,daily bowel movement diary call and other study procedures
Subjects 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 basalplasmacytosis, OR two sigmoidoscopies, at least 7 days apart showing evidence ofendoscopic activity
Exclusion
Exclusion Criteria:
Hospitalization of exacerbation of UC requiring intravenous corticosteroids
Patients already on biologics (anti-tumor necrosis factor inhibitors) or smallmolecules (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 orIHC and or tissue PCR) at screening. (The patients with positive assay will betreated appropriately and tests will be repeated. Those with negative assay andpersistent activity will be included in the study.)
Active or inadequately treated infections, including Mycobacterium tuberculosis.
Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectiouscolitis, 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, oruncontrolled renal, hepatic, Hematological, gastrointestinal, metabolic, endocrine,pulmonary, cardiac, or neurological disease.
Pregnant females
Study Design
Study Description
Connect with a study center
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, Delhi VINEET AHUJA
IndiaActive - Recruiting
Department of Gastroenterology, Lisie Hospital
Kochi, Kerala
IndiaSite Not Available
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra
IndiaSite Not Available
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab DR AJIT SOOD
IndiaSite Not Available
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research,
Chandigarh, Punjab/Haryana
IndiaSite Not Available
Department of Gastroenterology, Institute of Medical Sciences
Varanasi, Uttar Pradesh
IndiaSite Not Available
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