NCT04297488

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2018

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

5.1 years

First QC Date

June 8, 2018

Last Update Submit

February 7, 2023

Conditions

HIV-infection/Aids

Outcome Measures

Primary Outcomes (1)

  • 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

    Changes from baseline to 6 months

Secondary Outcomes (5)

  • Plasma levels of gut damage, microbial translocation and inflammation

    Changes from baseline to 6 months

  • Blood viral load

    Changes from baseline to 6 months

  • Metabolic measurements from blood plasma

    Changes from baseline to 6 months

  • Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures

    Changes from baseline to 6 months

  • Gut bacterial community diversity and composition

    Changes from baseline to 6 months

Study Arms (1)

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.

Dietary Supplement: Bifidobacteria and Lactobacilli triple viable capsules

Interventions

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.

INR(oral probiotic capsules containing 3 billion Bifidobacterium and 1 billion Lactobacillus)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented HIV-1 infection
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • WEI Lyu

    Department of Infectious Diseases, PekingUMCH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

QING ZHANG

CONTACT

15001278131zhangqingpumch@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2018

First Posted

March 5, 2020

Study Start

May 1, 2020

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)