B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
BifIID
Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial
3 other identifiers
interventional
200
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Aug 2023
Typical duration for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedStudy Start
First participant enrolled
August 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
August 22, 2024
August 1, 2024
2.8 years
June 19, 2023
August 20, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Gut microbiome
Alpha (Shannon) and Beta (Bray Curtis and UniFrac) diversity metrics on the entire microbial communities, assessed by bacterial shotgun metagenomics of infant stool, will be compared between treatment arms
4 weeks of age
Markers of intestinal inflammation and microbial translocation
Concentration of markers of intestinal inflammation and microbial translocation (Lipocalin-2 (Lcn-2), sCD163, I-FABP and LBP measured by ELISA in infant plasma) will be compared cross-sectionally at each time point between groups using Mann-Whitney U tests
4 - 36 weeks of age
BCG vaccine respone
Frequencies of total net cytokine producing cells in response to stimulation with BCG will be compared between arms.
7 weeks of age
BCG vaccine respone
Frequencies of total net cytokine producing cells in response to stimulation with BCG will be compared between arms.
36 weeks of age
Secondary Outcomes (3)
Longitudinal succession in gut microbiota composition, diversity and function
4 - 36 weeks of age
Stool metabolome
4 weeks of age
T cell subsets frequencies
4 - 36 weeks of age
Other Outcomes (5)
Presence of total B. infantis and B. infantis Rosell®-33 in stool
4 - 36 weeks of age
Infant neurodevelopment milestones
24 and 36 weeks of age
Infant growth
4 - 36 weeks of age
- +2 more other outcomes
Study Arms (2)
B. infantis Rosell®-33
ACTIVE COMPARATORParticipants will receive 8 x 109 CFU B. infantis Rosell®-33 per dose (single microbial active ingredient) and carrier material (maltodextrin) for 28 days from day 1-3 of life.
Placebo
PLACEBO COMPARATORParticipants will receive placebo (containing all materials besides B. infantis Rosell®-33) for 28 days from day 1-3 of life.
Interventions
Eligibility Criteria
You may qualify if:
- Willing and able to provide signed and dated informed consent form
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cape Townlead
- Seattle Children's Hospitalcollaborator
- University of Stellenboschcollaborator
- Institute for Systems Biologycollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- University of Washingtoncollaborator
Study Sites (1)
Khayelitsha Site B Midwife Obstetric Unit
Cape Town, South Africa
Related Publications (1)
Happel AU, Rametse L, Perumaul B, Diener C, Gibbons SM, Nyangahu DD, Donald KA, Gray C, Jaspan HB. 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 Oct 18;23(1):367. doi: 10.1186/s12906-023-04208-0.
PMID: 37853370DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Jaspan, MD PHD
Seattle Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 19, 2023
First Posted
June 28, 2023
Study Start
August 11, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
August 22, 2024
Record last verified: 2024-08