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

February 7, 2023 updated by: Peking Union Medical College Hospital

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Changes from baseline to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Changes from baseline to 6 months
Blood viral load
Time Frame: Changes from baseline to 6 months
HIV-RNA
Changes from baseline to 6 months
Metabolic measurements from blood plasma
Time Frame: Changes from baseline to 6 months
Vitamin D, glucose and insulin, and lipid profiling
Changes from baseline to 6 months
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
Changes from baseline to 6 months
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
Changes from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CACTGUT20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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