NCT07052409

Brief Summary

Research has shown that babies who are exposed to HIV, but are uninfected (negative HIV status), have a bigger risk of developing severe infections. There are naturally occurring organisms in the gut that may determine how the body protects itself against infections. These organisms may be different in babies who were exposed to the HIV virus in utero, compared to those who were not exposed. This study wants to see if the organisms in the gut of babies can be modified by supplementing the diet of the pregnant mother or of the baby at 6 months of age with Inkomasi (pasteurized fermented milk). The study will compare the type and amount of organisms in those who received supplementation and those who did not receive supplementation.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
37mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress28%
Apr 2025Jul 2029

Study Start

First participant enrolled

April 10, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

3.1 years

First QC Date

June 26, 2025

Last Update Submit

May 13, 2026

Conditions

Gut Microbiome

Keywords

Gut microbiomeHIV-exposed uninfected infant

Outcome Measures

Primary Outcomes (2)

  • Infant gut microbiome

    16s rRNA and metagenomic sequencing

    from enrollment to 4-10 weeks after enrollment

  • Maternal gut microbiome

    Shotgun metagenomics and 16s rRNA

    4-10 weeks after initiation of the intervention

Study Arms (2)

Inkomasi

ACTIVE COMPARATOR

Diet supplementation with pasteurized fermented milk

Dietary Supplement: Inkomazi

Control

NO INTERVENTION

No intervention

Interventions

InkomaziDIETARY_SUPPLEMENT

Pasteurized fermented milk

Inkomasi

Eligibility Criteria

Age6 Months - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women with HIV HIV-exposed uninfected infants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Witwatersrand

Johannesburg, South Africa

Location

Study Officials

  • Adriana Weinberg, MD

    AMC UCD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 4, 2025

Study Start

April 10, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

NICHD database

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
After study publication
Access Criteria
Demographic information will be deposited in the NICHD public database. Raw 16S rRNA gene sequences and shotgun metagenomic sequences, along with associated metadata, will be deposited in SRA following MIMARKS standard. External investigators will be able to access the data using standard search methods.

Locations

ZA(1)