Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03008941
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2016-12-28
Brief Title:
Microbiota Restoration Therapy in HIV With Repeated Low-Dose Interventions
Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Organization:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo Controlled Study of Repeated Low-Dose Fecal Microbiota Restoration in HIV-Infected Subjects The REFRESH Study
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFRESH
Brief Summary:
Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to contribute to chronic immune dysfunction Manipulation of the intestinal microbiota with nutritional interventions exert limited immunologic effects but a deep understanding of how these interventions could ameliorate gut dysbiosis and influence health among HIV-infected individuals remain unexplored In this Phase I clinical trial 30 HIV-infected subjects on effective ART with evidence of persistent immune dysfunction indicated by a CD4CD8 ratio1 will be included and randomized to either repeated low-dose oral fecal microbiota transplantation or placebo during 8 weeks The primary outcome will be safety Secondary outcomes will include changes in CD4 T cell counts CD8 T cell counts CD4CD8 ratio inflammatory markers T cell activation and markers of enterocyte barrier function through week 48 Engraftment on host microbiota will be examined using Illumina sequencing of the V3-V4 16S RNA and changes in bacterial metabolism and in the plasma metabolite fingerprint will be studied by combination of untargeted mass spectrometry and two different and complementary separation techniques in bacterial and plasma samples
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GESIDA 9116 | OTHER | GESIDA Study group | None |