NCT05923333Recruiting
B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial
Source: ClinicalTrials.gov · Last updated 22 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on: * gut microbiome composition and diversity at 4 weeks of life * markers of intestinal inflammation and microbial translocation at 4 weeks of life * Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life The secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on: * longitudinal succession of the gut microbiota composition, diversity and function * relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life * stool metabolome * T cell subset ontogeny during the first 9 months of life. Exploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves: * infant growth * all-cause morbidity * neurodevelopment during the first 9 months of life * antibody responses to early childhood vaccines
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 19 Jun 2023
- Start date
- Aug 2023
- Primary completion date
- Jun 2026
- Lead sponsor
- University of Cape Town
- Diseases
- HIV
- NCT number
- NCT05923333
What you commit to
- Study type: Interventional
- Planned participants: 200
- From Aug 2023 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe illnesses, e.g. Sepsis
- Chronic disorder or medications (other than antiretrovirals and cotrimoxazole prophylaxis) that in the opinion of the investigator would alter immunity
- Pregnancy or delivery complications including birth asphyxia, seizures, sepsis, major congenital anomalies or congenital infections
- Any condition that in the opinion of the investigator would make participation in the trial unsafe
Other
- current TB or known household TB contact
- Known contraindications to components of the interventional products
- Taking additional probiotics or prebiotics
Who the study is looking for
- Willing and able to provide signed and dated informed consent form
- 18 years of age or older
- Documented HIV seropositive
- Antiretroviral therapy initiated before the third trimester of pregnancy
- Planning on exclusively breastfeeding the infant for the first 6 months of life
- Documented HIV seronegative at birth
- Born at term (completed at least 37 weeks of gestation)
- Birth weight \>2.4kgs
Age in the registry: 0 days to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Khayelitsha Site B Midwife Obstetric Unit Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
Related publications
- Bifidobacterium infantis supplementation versus placebo in early life to improve immunity in infants exposed to HIV: a protocol for a randomized trial.BMC Complement Med Ther · 2023 · PMID 37853370
This page is information, not medical advice. Discuss any trial with your doctor.