Probiotic Supplementation for Those Immune Non-responders With HIV-1 Infection

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Enrolling

Conditions

HIV-infection/Aids

Treatments

Dietary Supplement: Bifidobacteria and Lactobacilli triple viable capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT04297488

CACTGUT20

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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