B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-11

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on:

* gut microbiome composition and diversity at 4 weeks of life
* markers of intestinal inflammation and microbial translocation at 4 weeks of life
* Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life

The secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on:

* longitudinal succession of the gut microbiota composition, diversity and function
* relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life
* stool metabolome
* T cell subset ontogeny during the first 9 months of life.

Exploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves:

* infant growth
* all-cause morbidity
* neurodevelopment during the first 9 months of life
* antibody responses to early childhood vaccines

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Developing Interventions for Protecting HIV-Exposed Uninfected Infants Against Severe Infections

NCT07052409

Gut Microbiome

ENROLLING_BY_INVITATION NA

A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children

NCT00000952

HIV Infections

COMPLETED PHASE1

A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection

NCT00000663

HIV Infections

COMPLETED PHASE1

Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies

NCT00000888

HIV Infections Pregnancy

COMPLETED PHASE1

Immune Function of Infants With HIV

NCT00073229

HIV Infections

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Infants who are born to mothers with HIV (exposed but uninfected; iHEU) are at higher risk of morbidity and display multiple immune alterations compared to infants who are HIV-unexposed (iHU). Easily implementable strategies to improve immunity of iHEU, and possibly subsequent health outcomes, are needed. iHEU have altered gut microbiome composition and bifidobacterial depletion, and relative abundance of Bifidobacterium infantis has been associated with immune ontogeny, including humoral and cellular vaccine responses. Therefore, a randomized trial of B. infantis Rosell®-33 versus placebo given during the first month of life in South African iHEU will be conducted.

This is a parallel, randomised, controlled study. Two-hundred breastfed iHEU will be enrolled from the Khayelitsha Site B Midwife Obstetric Unit in Cape Town, South Africa and 1:1 randomised to receive 8 x109 CFU B. infantis Rosell®-33 daily or placebo for the first 4 weeks of life, starting on day 1-3 of life. Infants will be followed over 36 weeks with extensive collection of meta-data and samples.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hiv Vaccine Reaction Microbial Colonization Infant Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

B. infantis Rosell®-33

Participants will receive 8 x 109 CFU B. infantis Rosell®-33 per dose (single microbial active ingredient) and carrier material (maltodextrin) for 28 days from day 1-3 of life.

Group Type ACTIVE_COMPARATOR

B. infantis Rosell®-33

Intervention Type DIETARY_SUPPLEMENT

B. infantis Rosell®-33 + maltodextrin

Placebo

Participants will receive placebo (containing all materials besides B. infantis Rosell®-33) for 28 days from day 1-3 of life.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

B. infantis Rosell®-33

B. infantis Rosell®-33 + maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing and able to provide signed and dated informed consent form
* 18 years of age or older
* Documented HIV seropositive
* Antiretroviral therapy initiated before the third trimester of pregnancy
* Planning on exclusively breastfeeding the infant for the first 6 months of life

* Documented HIV seronegative at birth
* Born at term (completed at least 37 weeks of gestation)
* Birth weight \>2.4kgs

Exclusion Criteria

* Severe illnesses, e.g. Sepsis
* current TB or known household TB contact
* Chronic disorder or medications (other than antiretrovirals and cotrimoxazole prophylaxis) that in the opinion of the investigator would alter immunity
* Pregnancy or delivery complications including birth asphyxia, seizures, sepsis, major congenital anomalies or congenital infections
* Known contraindications to components of the interventional products
* Taking additional probiotics or prebiotics
* Any condition that in the opinion of the investigator would make participation in the trial unsafe

Minimum Eligible Age

0 Days

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes