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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. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Experimental | Patients with NAFLD will receive orally fecal microbiota capsules from healthy donors |
|
| Placebo group | Placebo Comparator | Placebo capsules will be identical to the active capsules, but not contain intestinal bacteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRIM-DJ2727 | Drug | administration orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 months |
| Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant | 10 months | |
| Number of Participants With an Increase in Flora Diversity in Fecal Samples | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gut motility | Changes in gut motility will be determined using Smart Pill (if completed successfully pre and post treatment) measuring gut motility | 6 months |
| Monitor subjects' health information |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
administration orally placebo |
|
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.
| 10 months |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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