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

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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

Tracking Information
First Submitted Date  ICMJE June 8, 2018
First Posted Date  ICMJE March 5, 2020
Last Update Posted Date March 5, 2020
Estimated Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
  • 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)
  • Blood viral load [ Time Frame: Changes from baseline to 6 months ]
    HIV-RNA
  • Metabolic measurements from blood plasma [ Time Frame: Changes from baseline to 6 months ]
    Vitamin D, glucose and insulin, and lipid profiling
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotic Supplementation for Those Immune Non-responders With HIV-1 Infection
Official Title  ICMJE Effect and Safety of Probiotic Supplementation in Immune Non-responders With HIV-1 Infection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE HIV-infection/Aids
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: INR
Participants will receive oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily for 6 months.
Intervention: Dietary Supplement: Bifidobacteria and Lactobacilli triple viable capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qing Zhang +86-13207572893 1214345667@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04297488
Other Study ID Numbers  ICMJE CACTGUT20
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei LYU Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP