HIV InfectionsNCT04297501
Gut Microbiota Changes of HIV Patients Before and After One Year of ART
An observational study of HIV Infections, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
HIV infection leads to destruction of CD4+T cells in the gut-associated lymphoid tissue (GALT) and promotes a decline in mechanical barrier functions of the gut mucosa, and the subsequent translocation of microbial products from the gastrointestinal tract to systemic circulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Antiretroviral Therapy
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were recruited from the Department of Infectious Diseases, Peking Union Medical College Hospital, Beijing, China. All participants are Chinese and meet eligibility criteria.
Who may be able to join
- 18-65 years old;
- Documented HIV infection;
- No history of gastrointestinal diseases;
- Good adherence and promise to follow-up;
- Ability to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 1-year Antiretroviral Treatment on Gut Microbiota Diversity and Composition in Treatment-naïve HIV-infected Chinese Individuals
HIV infection leads to destruction of CD4+T cells in the gut-associated lymphoid tissue (GALT) and promotes a decline in mechanical barrier functions of the gut mucosa, and the subsequent translocation of microbial products from the gastrointestinal tract to systemic circulation. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Many studies have revealed strong and characteristic compositional differences in gut microbiota between individuals with HIV infection and seronegative controls. So far, several probiotic organisms have shown the ability to enhance intestinal epithelial barrier functions, reduce inflammation, and support effective Th-1 responses. Probiotics mainly stimulates polymeric IgA secretion, avoid bacterial overgrowth and their translocation, and produce a self-limited inflammatory response through development of regulatory T (Treg) cells by anti-inflammatory cytokine production. Therefore, we design a prospective, randomized, double-blind, placebo-controlled study to determine whether the use of a probiotic can expand beneficial microbiota that aid in decreasing bacterial translocation and pro-inflammatory cytokine production, thereby improving immune functions in HIV-infected subjects. Participants in the intervention group will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily, while those in the placebo group will take placebo which contains no probiotic but has the same flavor and characteristics as the probiotic product.. Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 12 months of receiving intervention will be analyzed.
- Conditions
- HIV Infections
- Being tested
- Antiretroviral Therapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiretroviral TherapyDrug
All participants receive antiretroviral therapy to control virus replication and restore CD4+ T-cell count.
| Study group | Role | What they receive |
|---|---|---|
| All participants | All enrolled participants in this study Receives: Drug: Antiretroviral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut bacterial community diversity and composition
Microbiota profiling are performed on fecal samples from each subjects, and 8-10 participants receive gastrointestinal endoscope according to their willingness
Measured: Change from baseline to 1 year after antiretroviral therapy
Secondary outcomes (7)
Absolute CD4+ T-cell and CD8+ T-cell counts in peripheral plasma
CD4+ and CD8+ T cells are analyzed by flow cytometry
Measured: Change from baseline to 1 year after antiretroviral therapy
The level of T cell activation and different immunophenotype in peripheral plasma
CD38+HLA-DR+, CD8+CD28+ T cell subsets are analyzed by flow cytometry
Measured: Change from baseline to 1 year after antiretroviral therapy
Plasma levels of inflammation and coagulation markers
Levels of IL-8, IL-1β, IL-6, CRP, TNF-α and D-dimer
Measured: Change from baseline to 1 year after antiretroviral therapy
Plasma levels of microbial translocation and monocyte activation markers
Levels of I-FABP, LPS, LBP, sCD14, sCD40L, and IDO
Measured: Change from baseline to 1 year after antiretroviral therapy
Metabolic measurements from blood plasma
Levels of vitamin D, glucose and insulin, and lipid profiling
Measured: Change from baseline to 1 year after antiretroviral therapy
Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures
Based on patients' description and intervention-related adverse events
Measured: Change from baseline to 1 year after antiretroviral therapy
HIV RNA
HIV-RNA is detected by Roche assay with the limit of 20 copies/mL
Measured: Change from baseline to 1 year after antiretroviral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Mar 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei LYU, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297501
- Sponsor's protocol ID
- CACTGUT18A
- Status last verified
- Feb 2018
- First submitted
- 8 Jun 2018
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 1-year Antiretroviral Treatment on Gut Microbiota Diversity and Composition in Treatment-naïve HIV-infected Chinese Individuals
- ClinicalTrials.gov ID
- NCT04297501
- Acronym / sponsor ID
- CACTGUT18A
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HIV infection leads to destruction of CD4+T cells in the gut-associated lymphoid tissue (GALT) and promotes a decline in mechanical barrier functions of the gut mucosa, and the subsequent translocation of microbial products from the gastrointestinal tract to systemic circulation. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Many studies have revealed strong and characteristic compositional differences in gut microbiota between individuals with HIV infection and seronegative controls. So far, several probiotic organisms have shown the ability to enhance intestinal epithelial barrier functions, reduce inflammation, and support effective Th-1 responses. Probiotics mainly stimulates polymeric IgA secretion, avoid bacterial overgrowth and their translocation, and produce a self-limited inflammatory response through development of regulatory T (Treg) cells by anti-inflammatory cytokine production. Therefore, we design a prospective, randomized, double-blind, placebo-controlled study to determine whether the use of a probiotic can expand beneficial microbiota that aid in decreasing bacterial translocation and pro-inflammatory cytokine production, thereby improving immune functions in HIV-infected subjects. Participants in the intervention group will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily, while those in the placebo group will take placebo which contains no probiotic but has the same flavor and characteristics as the probiotic product.. Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 12 months of receiving intervention will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Drug: Antiretroviral TherapyAll enrolled participants in this study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from the Department of Infectious Diseases, Peking Union Medical College Hospital, Beijing, China. All participants are Chinese and meet eligibility criteria.
Key inclusion criteria (5 listed)
- 18-65 years old;
- Documented HIV infection;
- No history of gastrointestinal diseases;
- Good adherence and promise to follow-up;
- Ability to provide informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiretroviral TherapyAll participants receive antiretroviral therapy to control virus replication and restore CD4+ T-cell count. | Drug | All participants |
Primary outcome
Gut bacterial community diversity and composition
Time frame: Change from baseline to 1 year after antiretroviral therapy
Microbiota profiling are performed on fecal samples from each subjects, and 8-10 participants receive gastrointestinal endoscope according to their willingness
7 secondary outcomes
Absolute CD4+ T-cell and CD8+ T-cell counts in peripheral plasma
Time frame: Change from baseline to 1 year after antiretroviral therapy
The level of T cell activation and different immunophenotype in peripheral plasma
Time frame: Change from baseline to 1 year after antiretroviral therapy
Plasma levels of inflammation and coagulation markers
Time frame: Change from baseline to 1 year after antiretroviral therapy
Plasma levels of microbial translocation and monocyte activation markers
Time frame: Change from baseline to 1 year after antiretroviral therapy
Metabolic measurements from blood plasma
Time frame: Change from baseline to 1 year after antiretroviral therapy
Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures
Time frame: Change from baseline to 1 year after antiretroviral therapy
HIV RNA
Time frame: Change from baseline to 1 year after antiretroviral therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei LYU principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut bacterial community diversity and composition (time frame: Change from baseline to 1 year after antiretroviral therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.