Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human … (NCT05282485) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides
South Africa140 participantsStarted 2022-06-02
Plain-language 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.
Who can participate
Age range
3 Weeks – 6 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 breas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of infants with infectious morbidity from 4-24 weeks
Timeframe: 4-24 weeks of age
2
Infant length for age Z scores (LAZ) from 4-24 weeks
Timeframe: 4-24 weeks of age
3
Proportion of infants with infectious morbidity from 4-48 weeks
Timeframe: 4-48 weeks of age
4
Infant length for age Z scores (LAZ) from 4-48 weeks