Adults With Ulcerative Colitis study: PRIM-DJ2727
Official title Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis
ClinicalTrials.gov ID: NCT04373473
What this study is testing
What is PRIM-DJ2727?
An investigational oral capsule containing lyophilized fecal microbiota being studied for ulcerative colitis remission.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if the capsules are safe and if they help keep ulcerative colitis from coming back. It will also look at how the gut bacteria change over time.
- Who it's for
- Adults who have ulcerative colitis and are currently in remission.
- What's involved
- Participants will take capsules that contain dried stool material, either the real product or a placebo, and will have regular check‑ups and stool tests to monitor health and gut bacteria.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 each subscore ≤1), and on stable maintenance therapy.
- Sexually active male and female people of childbearing potential must agree to use an effective method of birth control during the study.
- Female people of childbearing potential must have a negative urine Qualitative HCG pregnancy test at enrolment and on the Week 1, Day 1 of the...
You likely can't join if
- Unable to take multiple capsules orally.
- Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
- 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 bowel syndrome, microscopic colitis, celiac disease, short gut syndrome...
See the full eligibility 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 each subscore ≤1), and on stable maintenance therapy.
- Sexually active male and female people of childbearing potential must agree to use an effective method of birth control during the study.
- Female people of childbearing potential must have a negative urine Qualitative HCG pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
- Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
- Subject has an attending physician who will provide the non-FMT care.
- Unable to take multiple capsules orally.
- Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
- 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 bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures, chronic...
- Known history of bile acid diarrhea
- Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone \>20 mg a day or prednisone-equivalent)
- History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).
- History of use of an investigational drug within 90 days prior to the screening visit.
- History of significant uncontrolled systemic disease that in the opinion of the study 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 the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.