Phase
Condition
Inflammatory Bowel Disease
Inflammation
Crohn's Disease
Treatment
PRIM-DJ2727
Placebos
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult ≥18 years of age
History of active UC in the past 12 months based on standard clinical, endoscopic,or histologic criteria.
Remission of UC based on clinical grounds (partial Mayo score of ≤2 with eachsubscore ≤1), and on stable maintenance therapy.
Sexually active male and female subjects of childbearing potential must agree to usean effective method of birth control during the study.
Female subjects of childbearing potential must have a negative urine Qualitative HCGpregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior toadministration of study drug.
Willing and able to sign an informed consent form and attend all study-relatedclinic visits, assessments, and follow-up phone calls.
Subject has an attending physician who will provide the non-FMT care.
Exclusion
Exclusion Criteria:
Unable to take multiple capsules orally.
Females who are pregnant, breastfeeding, or planning to become pregnant during thestudy.
Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
History of recurrent Clostridium difficile infection or FMT in the past 6-months.
History of other active gastrointestinal conditions such as irritable bowelsyndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy,colectomy, gastrointestinal fistulae or strictures, chronic parasitic infections,diverticulitis etc.
Known history of bile acid diarrhea
Compromised immune system (e.g. primary immune disorders or clinicalimmunosuppression due to a medical condition or medication e.g. taking oralprednisone >20 mg a day or prednisone-equivalent)
History of active cancer and/or ongoing chemotherapy (superficial non-metastaticcancers and maintenance chemotherapy are permitted).
History of use of an investigational drug within 90 days prior to the screeningvisit.
History of significant uncontrolled systemic disease that in the opinion of thestudy investigator could interfere with study participation and/or objectives.
Life expectancy of < 1 year.
In the opinion of investigator, subject for any reason, should be excluded from thestudy.
Study Design
Connect with a study center
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesActive - Recruiting

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