Probiotic Supplementation for Those Immune Non-responders With HIV-1 Infection
- Conditions
- HIV-infection/Aids
- Interventions
- Dietary Supplement: Bifidobacteria and Lactobacilli triple viable capsules
- Registration Number
- NCT04297488
- Lead Sponsor
- Peking Union Medical College Hospital
- 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 after 6 months of receiving intervention will be analyzed.
- 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 non-responder" (INR) phenotype is associated with increased immune activation and with higher rates of AIDS and non-AIDS related conditions, and death. Poor gut integrity, increased microbial translocation, and reduced CD4 T-cell trafficking to the gut could be a source of ongoing inflammation in INR individuals. Researches have shown that the gut microbiota compositions are different in INRs and immunological responders (IRs). Probiotics, by modulation of gut microbiota, can help induce epithelial healing and prevent bacterial translocation. Probiotic supplementation, therefore, may be a nutritional target for INRs by boosting CD4 cell counts. We design a prospective, case-control, self-contrast study to explore the efficacy and safety of probiotic supplementation in INRs. Participants will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily. 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 after 6 months of receiving intervention will be analyzed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description INR(oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus) Bifidobacteria and Lactobacilli triple viable capsules Participants will receive oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily for 6 months.
- Primary Outcome Measures
Name Time Method Immune recovery and activation Changes from baseline to 6 months CD4+ T-cell and cluster of differentiation 8（CD8）+ T-cell counts, CD4/CD8 ratio, cluster of differentiation 38（CD38）+/ human leukocyte antigen(HLA）-HLA class II(DR)+ CD8+/CD4+ T cell ratio
- Secondary Outcome Measures
Name Time Method Plasma levels of gut damage, microbial translocation and inflammation Changes from baseline to 6 months interleukin(IL)-8, IL-1β, IL-6, tumor necrosis factor(TNF)-α, C reactive protein(CRP), D-dimer, Intestinal fatty aid binding protein(I-FABP), lipopolysaccharide(LPS) , lipopolysaccharide-binding protein(LBP), sCD14, sCD40L, and Kynurenine/Tryptophan ratio
Blood viral load Changes from baseline to 6 months HIV-RNA
Metabolic measurements from blood plasma Changes from baseline to 6 months Vitamin D, glucose and insulin, and lipid profiling
Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures Changes from baseline to 6 months Based on patients' description and intervention-related adverse events
Gut bacterial community diversity and composition Changes from baseline to 6 months Bacterial community diversity and composition determined by 16S ribosomal ribonucleic acid(rRNA) gene sequencing of fecal samples
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, China