Clinical trial NCT04297488: Probiotic Supplementation for Those Immune Non-responders With HIV-1 Infection
Official title: Effect and Safety of Probiotic Supplementation in Immune Non-responders With HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV-infection/Aids
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Immune recovery and activation
timeFrame: Changes from baseline to 6 months
Secondary outcomes:
measure: Plasma levels of gut damage, microbial translocation and inflammation
timeFrame: Changes from baseline to 6 months
measure: Blood viral load
timeFrame: Changes from baseline to 6 months
measure: Metabolic measurements from blood plasma
timeFrame: Changes from baseline to 6 months
measure: Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures
timeFrame: Changes from baseline to 6 months
measure: Gut bacterial community diversity and composition
timeFrame: Changes from baseline to 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Department of Infectious Diseases, PekingUMCH
name: WEI Lyu
role: PRINCIPAL_INVESTIGATOR
References: