An interventional study of Bifidobacteria and Lactobacilli triple viable capsules in HIV-infection/Aids, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Supportive care
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 20 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Participants will receive oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily for 6 months.
Dietary Supplement: Bifidobacteria and Lactobacilli triple viable capsules
Bifidobacteria and Lactobacilli triple viable capsules (provided by Shenzhen Wan he Pharmaceutical Co., Ltd., China) are bilayer mini pellets and are resistant to gastric acid. So Bifidobacterium billion Lactobacillus can only be released in intestine. Participants will take 1.27g (contain 3 billion Bifidobacterium and 1 billion Lactobacillus) once daily.
Immune recovery and activation
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
Time frame: Changes from baseline to 6 months
Plasma levels of gut damage, microbial translocation and inflammation
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
Time frame: Changes from baseline to 6 months
Blood viral load
HIV-RNA
Time frame: Changes from baseline to 6 months
Metabolic measurements from blood plasma
Vitamin D, glucose and insulin, and lipid profiling
Time frame: Changes from baseline to 6 months
Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures
Based on patients' description and intervention-related adverse events
Time frame: Changes from baseline to 6 months
Gut bacterial community diversity and composition
Bacterial community diversity and composition determined by 16S ribosomal ribonucleic acid(rRNA) gene sequencing of fecal samples
Time frame: Changes from baseline to 6 months
Plan to share: No
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Peking Union Medical College Hospital