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Study of Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis

This study is looking at two ways to deliver Fecal Microbiota Transplantation (FMT) for people with active Ulcerative Colitis (UC), a type of inflammatory bowel disease. You would receive either PRIM-DJ2727-FROZEN, given as an enema, or PRIM-DJ2727-CAPSULES, taken by mouth. Both contain healthy gut bacteria from screened donors. Researchers want to see how safe and effective these treatments are, and how they change the bacteria in your gut. To join, you must be at least 18 years old and have active UC. The study will measure changes in your disease severity (using the Partial Mayo Score) at week 5, and changes in your gut bacteria at baseline and after 4 weeks of treatment. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This interventional study plans to enroll 20 participants. It is evaluating two different ways to deliver Fecal Microbiota Transplantation (FMT).
What's involved
You would receive an induction dose of 100 grams of stool either as a frozen retention enema in clinic or as orally administered capsules. Your disease severity will be assessed at week 5, and gut bacteria changes will be measured at the start and after 4 weeks of treatment.
Compensation
Not stated in the trial record.
Follow-up
Your disease severity will be measured at week 5. Changes in your gut bacteria will be assessed at the start of the study and after 4 weeks of treatment.

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NCT05786404

Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

Recruiting
PHASE1Ages 18+InterventionalTreatment
The University of Texas Health Science Center, Houston
~20 participants
Updated 2024-05-10 on ClinicalTrials.gov
What's tested:PRIM-DJ2727 - FROZENPRIM-DJ2727 - CAPSULES

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)
Measured over week 5
+4 more outcomes measured

Conditions

Active Ulcerative Colitis (UC)

Explore related trials

Ulcerative Colitis

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Herbert L DuPont, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Herbert L DuPont, MD
[email protected]
713 500 6687
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore \>1)
Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
Female subjects of childbearing potential must have a negative urine Qualitative Human Chorionic Gonadotropin(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.

Exclusion

Subjects with sever UC (Mayo score of \>7)
Unable to take retention enema or 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 parasitic infections, diverticulitis etc.
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.
Absolute neutrophil count (ANC) \< 500IU/mL

What this trial measures

  • Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)week 5

    This is a 3 item questionnaire and each is measured from 0-3, for a maximum score of 9 a higher number indicating worse outcome

  • Change in fecal microbiota diversity and genera as assessed by sequencingBaseline,end of treatment (4 weeks after baseline)
  • Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility testBaseline,end of treatment (4 weeks after baseline)
  • Safety as assessed by the adverse events3 months after last dose

    Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)

  • Safety as assessed by the adverse events6 months after last dose

    Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)