Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes MelitusPhase 2NCT04371653
A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally in Subjects With Nonalcoholic Fatty Liver Disease
A Phase 2 study testing PRIM-DJ2727 in people with Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus, run by The University of Texas Health Science Center, Houston.
Trial summary
Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- ≥ 18 years of age
- For sexually active male and female subjects of childbearing potential, agree to use an effective method of birth control during the study.
- For female subjects of childbearing potential, a negative urine Qualitative HCG pregnancy test at enrollment 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 study assessments and follow up visits.
- A documented diagnosis of NAFLD without cirrhosis based on imaging or clinical judgment of a gastroenterologist or hepatologist.
- History of diabetes mellitus
- Has an attending physician who will provide non-transplant care for the subject.
- Agrees to maintain a stable regimen including weight loss, exercise, medications to control lipids and glucose, and vitamin E therapy if already prescribed, during participation in the study
Who cannot join
- Unable to take multiple capsules orally.
- Alcohol consumption of greater than an average of one drink per day for women and two drinks per day for men.
- Hemochromatosis.
- Hepatic encephalopathy.
- 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)
- Receipt of systemic non-topical antibiotic therapy within 14 days of treatment day 1.
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- History of use of an investigational drug within 90 days prior to the screening visit.
- Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
- Current history for active states of Inflammatory bowel disease, Irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures.
- 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.
About this study
Official title: A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Nonalcoholic Fatty Liver Disease (NAFLD)
Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .
- Being tested
- PRIM-DJ2727, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIM-DJ2727Drug
administration orally
PlaceboDrug
administration orally placebo
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Patients with NAFLD will receive orally fecal microbiota capsules from healthy donors Receives: Drug: PRIM-DJ2727 |
| Placebo group | Placebo comparator | Placebo capsules will be identical to the active capsules, but not contain intestinal bacteria Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.
Measured: 10 months
Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
Measured: 10 months
Number of Participants With an Increase in Flora Diversity in Fecal Samples
Measured: 10 months
Secondary outcomes (2)
Changes in gut motility
Changes in gut motility will be determined using Smart Pill (if completed successfully pre and post treatment) measuring gut motility
Measured: 6 months
Monitor subjects' health information
The SF-36 will be administered at enrollment, follow-up clinic visits at Week 13 and 9 month, and early termination visit. Rapid Eating Assessment for Patients (REAP) is to help quickly assess diet and physical activity of individuals. In addition, subjects will be asked to maintain a paper diary recording number of BM per day and type of each BM after enrollment. Information such as hospitalizations or mortality from any cause will be collected as part of the health outcomes assessment throughout this study.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes MelitusStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- 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
- NCT04371653
- Sponsor's protocol ID
- HSC-SPH-19-1126
- Status last verified
- May 2024
- First submitted
- 22 Apr 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Nonalcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT04371653
- Acronym / sponsor ID
- HSC-SPH-19-1126
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 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.
Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .
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 |
|---|---|---|
| Active group | Experimental | Drug: PRIM-DJ2727Patients with NAFLD will receive orally fecal microbiota capsules from healthy donors |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo capsules will be identical to the active capsules, but 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 (8 listed)
- ≥ 18 years of age
- For sexually active male and female subjects of childbearing potential, agree to use an effective method of birth control during the study.
- For female subjects of childbearing potential, a negative urine Qualitative HCG pregnancy test at enrollment 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 study assessments and follow up visits.
- A documented diagnosis of NAFLD without cirrhosis based on imaging or clinical judgment of a gastroenterologist or hepatologist.
Key exclusion criteria (12 listed)
- Unable to take multiple capsules orally.
- Alcohol consumption of greater than an average of one drink per day for women and two drinks per day for men.
- Hemochromatosis.
- Hepatic encephalopathy.
- 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)
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-DJ2727administration orally | Drug | Active group |
| Placeboadministration orally placebo | Drug | Placebo group |
Primary outcome
Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
Time frame: 10 months
The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.
Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
Time frame: 10 months
Number of Participants With an Increase in Flora Diversity in Fecal Samples
Time frame: 10 months
2 secondary outcomes
Changes in gut motility
Time frame: 6 months
Monitor subjects' health information
Time frame: 10 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRIM-DJ2727 in people with Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus, run by The University of Texas Health Science Center, Houston.
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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index (time frame: 10 months). The study lists 3 primary outcomes in all. 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 14 May 2024.