Status:
UNKNOWN
Probiotic Supplementation for Those Immune Non-responders With HIV-1 Infection
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
HIV-infection/Aids
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma/mucosa, plasma levels of gut damage, microbial translocation and inflammation at baseline and aft...
Detailed Description
Up to 25% of HIV-infected individuals receiving antiretroviral treatment demonstrate suboptimal blood cluster of differentiation 4（CD4） recovery despite effective viral suppression; this "immunologic ...
Eligibility Criteria
Inclusion
- Documented HIV-1 infection
- 18-65 years old
- On antiretroviral therapy (\>2 years)
- Ability to provide informed consent
- Undetectable plasma HIV-1 viral load for the past 2 years
- CD4 T-cell count \<350/mm3 for the last 2 years
- No history of gastrointestinal diseases
Exclusion
- Administration of antibiotics, probiotics, or prebiotics or experience of diarrhea within the previous 3 months;
- Administration of anti-inflammatory drugs, corticosteroids, immunosuppressive drugs, immunomodulator within the previous 3 months;
- Severe organ dysfunction
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04297488
Start Date
May 1 2020
End Date
July 1 2025
Last Update
February 9 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730