Probiotic supplementation for HIV-infected individuals with poor immune response
Effect and Safety of Probiotic Supplementation in Immune Non-responders With HIV-1 Infection
This study tests whether taking daily probiotics can help people with HIV who have weak immune systems improve their gut health and boost their immune response.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04297488 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of probiotic supplementation on individuals with HIV-1 infection who are classified as immunologic non-responders (INRs). Participants will receive a daily oral probiotic containing Bifidobacterium and Lactobacillus for six months. The study aims to analyze changes in gut bacterial diversity, immune recovery, and inflammation levels before and after the intervention. By understanding the impact of probiotics on gut health and immune function, the research seeks to improve CD4 T-cell counts in INRs.
Who should consider this trial
Good fit: Ideal candidates are HIV-1 infected individuals aged 18-65 who have been on antiretroviral therapy for over two years and have a CD4 T-cell count below 350/mm3.
Not a fit: Patients with a history of gastrointestinal diseases or those who have recently taken antibiotics or anti-inflammatory medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance immune recovery and overall health in HIV-infected individuals who struggle with inadequate immune response.
How similar studies have performed: While the approach of using probiotics in this context is novel, previous studies have indicated potential benefits of probiotics in modulating gut health and immune function.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: WEI Lyu — Department of Infectious Diseases, PekingUMCH
- Study coordinator: Qing Zhang
- Email: zhangqingpumch@163.com
- Phone: 15001278131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.