Adults With Ulcerative ColitisPhase 2NCT04373473
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 2 study testing PRIM-DJ2727 in people with Adults With Ulcerative Colitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adults With Ulcerative Colitis
- What is being tested?
- PRIM-DJ2727
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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 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.
Who cannot join
- 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 parasitic infections, diverticulitis etc.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Herbert L DuPont, MD, 713 500 9366, herbert.l.dupont@uth.tmc.edu
Zhi-Dong Jiang, Dr.PH, 713 500 9371, zhi-dong.jiang@uth.tmc.edu
About this study
Official title: 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
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.
- Conditions
- Adults With Ulcerative Colitis
- Being tested
- PRIM-DJ2727, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIM-DJ2727Drug
Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727 capsules consists of lyophilized microbiota suspension from well-screened donors. Microbiota from three donors will be combined to make the product.
PlacebosDrug
Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Patients with UC will receive FMT capsules | Experimental | Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors Receives: Drug: PRIM-DJ2727 |
| Patients with UC will receive placebo | Placebo comparator | Patients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3
Measured: 9 months
Secondary outcomes (2)
Quality of life will be characterized by health-related quality of life score.
Measured: 9 months
Subject-reported score in Hospital Anxiety and Depression Scale
After administering 12 weeks of PRIM-DJ2727
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start14 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herbert DuPont, MD, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373473
- Sponsor's protocol ID
- HSC-MS-20-0316
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2020
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04373473
- Acronym / sponsor ID
- HSC-MS-20-0316
- Conditions
- Adults With Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with UC will receive FMT capsules | Experimental | Drug: PRIM-DJ2727Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors |
| Patients with UC will receive placebo | Placebo comparator | Drug: PlacebosPatients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 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 HCG pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIM-DJ2727Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727 capsules consists of lyophilized microbiota suspension from well-screened donors. Microbiota from three donors will be combined to make the product. | Drug | Patients with UC will receive FMT capsules |
| PlacebosPlacebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. | Drug | Patients with UC will receive placebo |
Primary outcome
Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3
Time frame: 9 months
2 secondary outcomes
Quality of life will be characterized by health-related quality of life score.
Time frame: 9 months
Subject-reported score in Hospital Anxiety and Depression Scale
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRIM-DJ2727 in people with Adults With Ulcerative Colitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Herbert DuPont, md (713 500 6687, herbert.l.dupont@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3 (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.