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Could a simple supplement protect HIV-Exposed babies from infections?

NCT ID NCT05282485

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study tests whether a synbiotic supplement (a mix of a prebiotic called 2'-FL HMO and a probiotic called B. infantis) can reduce infections and improve growth in infants who were exposed to HIV but are not infected themselves. About 140 infants will receive either the supplement or a placebo from 4 to 24 weeks of age. Researchers will track infections, growth, and development up to 72 weeks old.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Synbiotic (2'-FL human milk oligosaccharide + Bifidobacterium infantis probiotic)
What this could lead to
If it works, this could offer a simple dietary supplement to help HIV-exposed infants fight infections and grow better, reducing health gaps compared to unexposed babies.
What could go wrong
This is a small, early-stage trial with 140 infants, so results may not apply broadly. The supplement may cause digestive discomfort or show no benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

140 people

The number who actually took part.

Started

Jun 2022

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 6 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Worcester Campus of Stellenbosch University (SU)

    Stellenbosch, Western Cape, 7599, South Africa

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Other studies related to the condition(s) this trial covers.