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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297488
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : February 9, 2023
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV-infection/Aids Dietary Supplement: Bifidobacteria and Lactobacilli triple viable capsules Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect and Safety of Probiotic Supplementation in Immune Non-responders With HIV-1 Infection
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: INR(oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Immune recovery and activation [ Time Frame: Changes from baseline to 6 months ]
    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


Secondary Outcome Measures :
  1. Plasma levels of gut damage, microbial translocation and inflammation [ Time Frame: Changes from baseline to 6 months ]
    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

  2. Blood viral load [ Time Frame: Changes from baseline to 6 months ]
    HIV-RNA

  3. Metabolic measurements from blood plasma [ Time Frame: Changes from baseline to 6 months ]
    Vitamin D, glucose and insulin, and lipid profiling

  4. Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures [ Time Frame: Changes from baseline to 6 months ]
    Based on patients' description and intervention-related adverse events

  5. Gut bacterial community diversity and composition [ Time Frame: Changes from baseline to 6 months ]
    Bacterial community diversity and composition determined by 16S ribosomal ribonucleic acid(rRNA) gene sequencing of fecal samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297488


Contacts
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Contact: QING ZHANG 15001278131 ext +86 zhangqingpumch@163.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Wei LYU    010-69155081    lvweipumch@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: WEI Lyu Department of Infectious Diseases, PekingUMCH
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04297488    
Other Study ID Numbers: CACTGUT20
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases