Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides (MIGH-T MO)

June 30, 2026 updated by: Rupak Shivakoti, Columbia University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Children who are HIV-exposed uninfected (CHEU), i.e., children born to mothers with HIV but who do not acquire HIV infection, have a higher risk of mortality, infectious morbidity, and growth deficits than children who are HIV-unexposed uninfected (CHUU), i.e., children whose mothers do not have HIV. Prior research has focused on breastfeeding and has pointed to changes in human milk oligosaccharides (HMOs) associated with maternal HIV infection that appear to influence the infant microbiome and thereby lead to these adverse outcomes. A randomized trial of an intervention which combines HMOs and probiotics in breastfed CHEU will be conducted in South Africa to evaluate whether this intervention has the potential to reduce excess infectious morbidity and growth faltering risks observed in CHEU. CHEU will be randomized 1:1 to either a) intervention (synbiotic: 2'-FL HMO + B. infantis probiotic) or b) placebo (Maltodextrin). The study intervention or placebo will be given from 4-24 weeks of age (total 20 weeks), followed by another 48 weeks of observation off study treatment. Both arms will be followed to 72 weeks of age for assessment of infant outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Africa
    • Western Cape
      • Stellenbosch, Western Cape, South Africa, 7599
        • Worcester Campus of Stellenbosch University (SU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 weeks to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Mothers:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Greater than 18 years of age
  • For HIV-exposed uninfected children (CHEU): Mothers living with HIV documented based on medical record and with viral suppression (i.e., <400 copies/mL viral load) documented at delivery
  • For HIV-unexposed uninfected children (CHUU): Mothers without HIV (document HIV-negative test result at delivery or screening)

  • Women who initiated breastfeeding of their infant including:

    • Women who currently exclusively breastfeed their infants, or
    • Women who breastfed their infants for a period but are no longer breastfeeding, or
    • Women who are currently breastfeeding their infants in addition to feeding them formula milk or solids
  • For women with HIV: Those currently on first-line standard of care antiretroviral therapy that was initiated a minimum of 12 weeks prior to delivery of the infant included in this study
  • Participant has a cell phone that can be used for calls and messages
  • Agreement to adhere to Lifestyle Considerations throughout study duration

Inclusion Criteria for Children:

  • 3-6 weeks of age
  • Delivered from a singleton pregnancy
  • For children of mothers with HIV: At least one HIV diagnostic nucleic acid amplification test prior to enrollment which is negative and no positive test
  • Child is well enough to have established full breastfeeding by the time of enrollment

Exclusion Criteria:

  • Severe maternal or infant illness (e.g., maternal: tuberculosis, major psychiatric or neurological conditions; infant: any congenitally-acquired infections, major congenital anomalies)
  • Use of immunomodulatory or immunosuppressive drugs in either mother or child prior to enrollment in the study
  • For mothers with HIV: Mothers who are not currently receiving antiretroviral therapy or who are on regimens other than the currently recommended first-line standard of care in South Africa i.e., first-line dolutegravir- or efavirenz-based regimens.
  • Children infected with HIV
  • Mother or infant currently taking probiotics, prebiotics, or fiber supplements; or on any nutritional supplements (e.g., FM85) that impact the outcomes of interest
  • Mother or infant currently taking antibiotics for more than 14 days, excluding preventative therapies
  • Known allergic reactions to components of the treatment or placebo
  • Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the aims of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Synbiotic Group
A synbiotic combining 2'-Fucosyllactose (2'-FL) human milk oligosaccharides (HMO) with B.infantis (probiotic) will be administered to infants from 4 to 24 weeks of age.
Dietary supplement: Synbiotic
Synbiotic (2'-FL HMO + B. infantis probiotics)
Placebo Comparator: Placebo Group
Maltodextrin will be administered to infants from 4 to 24 weeks of age.
Dietary supplement: Maltodextrin
Maltodextrin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of infants with infectious morbidity from 4-24 weeks
Time Frame: 4-24 weeks of age
Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms
4-24 weeks of age
Infant length for age Z scores (LAZ) from 4-24 weeks
Time Frame: 4-24 weeks of age
Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms
4-24 weeks of age
Proportion of infants with infectious morbidity from 4-48 weeks
Time Frame: 4-48 weeks of age
Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms
4-48 weeks of age
Infant length for age Z scores (LAZ) from 4-48 weeks
Time Frame: 4-48 weeks of age
Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms
4-48 weeks of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infant plasma metabolite levels
Time Frame: 4-24 weeks of age
Unbiased metabolomics will be used to investigate whether metabolite levels and major metabolic pathways are different between the two arms
4-24 weeks of age
Infant plasma inflammatory markers and growth hormone levels
Time Frame: 4-48 weeks of age
Levels of protein inflammatory markers and growth hormones will be measured using immunoassays and will be compared between the two arms
4-48 weeks of age
Infant plasma HMO levels
Time Frame: 4-24 weeks of age
Infant HMO levels will be measured and compared between the two arms
4-24 weeks of age
Proportion of infants with Adverse Events (AEs)/Serious Adverse Event (SAEs)
Time Frame: Through 24 weeks of age
Proportion of AE/SAEs will be recorded and compared between the two arms to assess the safety of the intervention
Through 24 weeks of age
Proportion of infants with tolerability symptoms
Time Frame: Through 8 weeks of age
Digestive tolerability will be assessed and compared between the two arms to assess the safety of the intervention
Through 8 weeks of age
Proportion of infants with severe infectious morbidity
Time Frame: 4-48 weeks of age
Severe infectious morbidity (i.e., those requiring hospitalizations) data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms
4-48 weeks of age
Infant weight for age (WAZ) and weight for length (WLZ) Z scores from 4-24 weeks
Time Frame: 4-24 weeks of age
Infant anthropometry will be recorded at each visit to calculate infant weight for age (WAZ) and weight for length (WLZ) Z scores and will be compared between the two arms
4-24 weeks of age
Infant weight for age (WAZ) and weight for length (WLZ) Z scores from 4-48 weeks
Time Frame: 4-48 weeks of age
Infant anthropometry will be recorded at each visit to calculate infant weight for age (WAZ) and weight for length (WLZ) Z scores and will be compared between the two arms
4-48 weeks of age
Infant length for age (LAZ), weight for age (WAZ) and weight for length (WLZ) Z scores from 4-72 weeks
Time Frame: 4-72 weeks of age
Infant anthropometry will be recorded at each visit to calculate infant length for age (LAZ), weight for age (WAZ) and weight for length (WLZ) Z scores and will be compared between the two arms
4-72 weeks of age
Infant microbiota-for-age Z scores (MAZ)
Time Frame: 4-72 weeks of age
Infant microbiota-for-age Z scores (MAZ), a measure of infant microbiome maturity, will be compared between the two arms
4-72 weeks of age
Infant microbiota diversity
Time Frame: 4-72 weeks of age
Microbiota diversity of taxa will be compared between the two arms
4-72 weeks of age
Infant microbiota relative abundance
Time Frame: 4-72 weeks of age
Microbiota relative abundance of taxa will be compared between the two arms
4-72 weeks of age
Infant fecal short-chain fatty acid levels
Time Frame: 4-72 weeks of age
Short-chain fatty acid (SCFA) levels in stool samples from infants will be compared between the two arms
4-72 weeks of age
Infant neurodevelopment milestones
Time Frame: 48-72 weeks
A comprehensive neurodevelopment assessment, i.e., Griffiths III scale, will be conducted on infants at weeks 48 and 72 and the proportion passing each milestone will be compared between the two arms
48-72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Diego
University of California, Los Angeles
University of Stellenbosch

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rupak Shivakoti, PhD, Columbia University Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAT8393
  • R01HD105492 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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