HIV-infection/AidsNCT04297488
Probiotic Supplementation for Those Immune Non-responders With HIV-1 Infection
A study testing Bifidobacteria and Lactobacilli triple viable capsules in people with HIV-infection/Aids, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-infection/Aids
- What is being tested?
- Bifidobacteria and Lactobacilli triple viable capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 1 Jul 2025
- Phase
- Interventional
- 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
Who may be able to join
- 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
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.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Wei LYU, 010-69155081, lvweipumch@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV-infection/Aids
- Being tested
- Bifidobacteria and Lactobacilli triple viable capsules
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacteria and Lactobacilli triple viable capsulesDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| INR(oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus) | Experimental | Participants will receive oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily for 6 months. Receives: Dietary Supplement: Bifidobacteria and Lactobacilli triple viable capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune recovery and activation
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
Measured: Changes from baseline to 6 months
Secondary outcomes (5)
Plasma levels of gut damage, microbial translocation and inflammation
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
Measured: Changes from baseline to 6 months
Blood viral load
HIV-RNA
Measured: Changes from baseline to 6 months
Metabolic measurements from blood plasma
Vitamin D, glucose and insulin, and lipid profiling
Measured: Changes from baseline to 6 months
Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures
Based on patients' description and intervention-related adverse events
Measured: Changes from baseline to 6 months
Gut bacterial community diversity and composition
Bacterial community diversity and composition determined by 16S ribosomal ribonucleic acid(rRNA) gene sequencing of fecal samples
Measured: Changes from baseline to 6 months
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 May 2020
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infection/AidsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WEI Lyu, Principal investigator, Department of Infectious Diseases, PekingUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297488
- Sponsor's protocol ID
- CACTGUT20
- Status last verified
- Feb 2023
- First submitted
- 8 Jun 2018
- Last updated
- 9 Feb 2023
- Results posted
- 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 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Probiotic Supplementation in Immune Non-responders With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT04297488
- Acronym / sponsor ID
- CACTGUT20
- Conditions
- HIV-infection/Aids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- 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.
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
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INR(oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus) | Experimental | Dietary Supplement: Bifidobacteria and Lactobacilli triple viable capsulesParticipants will receive oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily for 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Bifidobacteria and Lactobacilli triple viable capsulesBifidobacteria 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. | Dietary supplement | INR(oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus) |
Primary outcome
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
5 secondary outcomes
Plasma levels of gut damage, microbial translocation and inflammation
Time frame: Changes from baseline to 6 months
Blood viral load
Time frame: Changes from baseline to 6 months
Metabolic measurements from blood plasma
Time frame: 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
Gut bacterial community diversity and composition
Time frame: Changes from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- 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
Department of Infectious Diseases, PekingUMCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacteria and Lactobacilli triple viable capsules in people with HIV-infection/Aids, 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 7 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact QING ZHANG (15001278131 ext. +86, zhangqingpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune recovery and activation (time frame: Changes from baseline to 6 months). 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 9 Feb 2023.