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

NCT05923333 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-22

No results posted yet for this study

Summary

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

Conditions

  • Hiv
  • Vaccine Reaction
  • Microbial Colonization
  • Infant Development

Interventions

DIETARY_SUPPLEMENT

B. infantis Rosell®-33

B. infantis Rosell®-33 + maltodextrin

DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Sponsors & Collaborators

  • Seattle Children's Hospital

    collaborator OTHER

  • University of Stellenbosch

    collaborator OTHER

  • Institute for Systems Biology

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Washington

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Heather Jaspan, MD PHD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-11
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05923333 on ClinicalTrials.gov