Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT05923333
Eligibility Criteria:
Inclusion Criteria Mother:
* 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
Inclusion Criteria Infant:
* Documented HIV seronegative at birth
* Born at term (completed at least 37 weeks of gestation)
* Birth weight \>2.4kgs
Exclusion Criteria:
* Severe illnesses, e.g. Sepsis
* current TB or known household TB contact
* 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
* Known contraindications to components of the interventional products
* Taking additional probiotics or prebiotics
* Any condition that in the opinion of the investigator would make participation in the trial unsafe
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
50 Years
Study:
NCT05923333
Study Brief:
Protocol Section:
NCT05923333