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

Phase

N/A

Condition

Aids And Aids Related Infections

Hiv Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT04297488

CACTGUT20

Ages 18-65
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Administration of antibiotics, probiotics, or prebiotics or experience of diarrheawithin 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

May 01, 2020

July 01, 2025

Study 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.

Connect with a study center

Peking Union Medical College Hospital
Beijing, 100730
China
Active - Recruiting

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