RightFit
RecruitingPhase 2

Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether PRIM-DJ2727 capsules are safe and help prevent ulcerative colitis from coming back or causing bowel swelling. The capsules contain freeze-dried stool microbes and are compared with a placebo, which has no active treatment. The study is for adults whose ulcerative colitis is in remission, meaning symptoms are mostly gone.

The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You had active ulcerative colitis in the past 12 months, confirmed by symptoms or tests.
  • Your ulcerative colitis is now in remission based on the study’s symptom score, and your treatment to keep it under control is stable.
  • If you are sexually active and you or your partner could become pregnant, you agree to use effective birth control during the study.
  • If you could become pregnant, you must have negative urine pregnancy tests at enrollment and before your first treatment.
  • You are willing and able to sign a consent form and complete all study visits, tests, and follow-up calls.
  • You have a doctor who will provide your care outside the stool microbe treatment.

Who can't join

  • You cannot swallow several capsules, or you are pregnant, breastfeeding, or planning to become pregnant during the study.
  • You took antibiotics that work throughout the body within 14 days before the first treatment, or an experimental drug within 90 days before screening.
  • You test positive for active HIV, hepatitis B, or hepatitis C infection.
  • You have a history of repeated C. difficile bowel infections or had a stool microbe transplant in the past 6 months.
  • You have other active digestive conditions, certain bowel surgeries or problems, long-term parasite infections, or diarrhea caused by bile acids.
  • Your immune system is weakened by illness or medicine, such as more than 20 mg of oral prednisone daily or a similar dose of another steroid.
  • You have a history of active cancer or are receiving chemotherapy. Surface cancers that have not spread and maintenance chemotherapy are allowed.
  • You have a serious uncontrolled illness that could affect the study, are expected to live less than 1 year, or the study doctor believes you should not join for another reason.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Adult ≥18 years of age 2. History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria. 3. Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy. 4. Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study. 5. Female subjects 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. 6. Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls. 7. Subject has an attending physician who will provide the non-FMT care. Exclusion Criteria: 1. Unable to take multiple capsules orally. 2. Females who are pregnant, breastfeeding, or planning to become pregnant during the study. 3. Receipt of systemic non-topical antibiotics within 14 days of treatment day 1. 4. Positive results for active HIV, Hepatitis B, or Hepatitis C infections. 5. History of recurrent Clostridium difficile infection or FMT in the past 6-months. 6. 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 parasitic infections, diverticulitis etc. 7. Known history of bile acid diarrhea 8. 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) 9. History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted). 10. History of use of an investigational drug within 90 days prior to the screening visit. 11. History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives. 12. Life expectancy of \< 1 year. 13. In the opinion of investigator, subject for any reason, should be excluded from the study.

Study sites (1)

TX