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

HIV-infection/Aids Clinical Trial

Official title:

Effect and Safety of Probiotic Supplementation in Immune Non-responders With HIV-1 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297488
• Other study ID #: CACTGUT20
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2023
• Source: Peking Union Medical College Hospital
• Contact: QING ZHANG
• Phone: 15001278131
• Email: zhangqingpumch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• HIV-infection/Aids
• Infections

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes from baseline to 6 months
Secondary	Plasma levels of gut damage, microbial translocation and inflammation	interleukin(IL)-8, IL-1ß, IL-6, tumor necrosis factor(TNF)-a, 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	Changes from baseline to 6 months
Secondary	Blood viral load	HIV-RNA	Changes from baseline to 6 months
Secondary	Metabolic measurements from blood plasma	Vitamin D, glucose and insulin, and lipid profiling	Changes from baseline to 6 months
Secondary	Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures	Based on patients' description and intervention-related adverse events	Changes from baseline to 6 months
Secondary	Gut bacterial community diversity and composition	Bacterial community diversity and composition determined by 16S ribosomal ribonucleic acid(rRNA) gene sequencing of fecal samples	Changes from baseline to 6 months