| Trial ID: | L0031 |
| Source ID: | NCT04371653
|
| Associated Drug: |
PRIM-DJ2727
|
| Title: |
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 Nonalc
|
| Acronym: |
--
|
| Status: |
Not yet recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
|
| Interventions: |
Drug: PRIM-DJ2727|Drug: Placebo
|
| Outcome Measures: |
Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index|Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant|Number of Participants With an Increase in Flora Diversity in Fecal Samples|Changes in gut motility|Monitor subjects' health information
|
| Sponsor/Collaborators: |
The University of Texas Health Science Center, Houston
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
12
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
December 1, 2021
|
| Completion Date: |
June 1, 2023
|
| Results First Posted: |
--
|
| Last Update Posted: |
January 22, 2021
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT04371653
|
