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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 : Not yet recruiting
First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
Up to 25% of HIV-infected individuals receiving antiretroviral treatment demonstrate suboptimal blood 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: INR
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 Wanhe Pharmaceutical Co., Ltd., China) are bilayer minipellets 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.




Primary Outcome Measures :
  1. Immune recovery and activation [ Time Frame: Changes from baseline to 6 months ]
    CD4+ T-cell and CD8+ T-cell counts, CD4/CD8 ratio, CD38+/HLA-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 ]
    IL-8, IL-1β, IL-6, TNF-α, CRP, D-dimer, I-FABP, LPS, LBP, sCD14, sCD40L, and IDO (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 by16S rRNA gene sequencing of fecal samples



Information from the National Library of Medicine

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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

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 +86-13207572893 1214345667@qq.com

Locations
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China
Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Wei LYU Peking Union Medical College Hospital

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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: March 5, 2020
Last Verified: February 2020
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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Infection
Communicable Diseases