Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides

Summary

Primary Objective:

* To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age.
* To evaluate the effects of synbiotics on infectious morbidity and growth from 4 to 48 weeks of age.

Secondary Objectives:

* To evaluate the effects of synbiotics on growth from 4 to 72 weeks of age.
* To evaluate the effects of synbiotics on infant neurodevelopment at 48 and 72 weeks of age.
* To evaluate the effects of synbiotics on biological measurements while it is in place from 4 to 24 weeks of age.
* To evaluate the effects of synbiotics on biological measurements from 4 to 48 weeks of age.
* To evaluate the effects of synbiotics on gut microbiome and fecal short chain fatty acids from 4 to 72 weeks of age.
* To investigate feasibility, acceptance, tolerability, and behavioral adherence with the intervention.
* To investigate whether the synbiotics reduces infectious morbidity and improves growth in CHEU relative to CHUU.
* To investigate whether infant gut microbiota composition, maturity and function, and markers of inflammation and HMOs at baseline and over time are associated with morbidity and poor growth in CHEU and CHUU.

Conditions

• HIV
• Infant Morbidity
• Breast Feeding

Interventions

DIETARY_SUPPLEMENT

Synbiotic

Synbiotic (2'-FL HMO + B. infantis probiotics)

DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin

Sponsors & Collaborators

• University of Stellenbosch

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

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

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Rupak Shivakoti, PhD · Columbia University Assistant Professor

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Weeks

Max Age

6 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-02

Primary Completion

2026-09-15

Completion

2026-09-15

Countries

• South Africa

Study Locations