B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV

Официальное название

Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial

Обзор

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

Подробное описание

Infants who are born to mothers with HIV (exposed but uninfected; iHEU) are at higher risk of morbidity and display multiple immune alterations compared to infants who are HIV-unexposed (iHU). Easily implementable strategies to improve immunity of iHEU, and possibly subsequent health outcomes, are needed. iHEU have altered gut microbiome composition and bifidobacterial depletion, and relative abundance of Bifidobacterium infantis has been associated with immune ontogeny, including humoral and cellular vaccine responses. Therefore, a randomized trial of B. infantis Rosell®-33 versus placebo given during the first month of life in South African iHEU will be conducted.

This is a parallel, randomised, controlled study. Two-hundred breastfed iHEU will be enrolled from the Khayelitsha Site B Midwife Obstetric Unit in Cape Town, South Africa and 1:1 randomised to receive 8 x109 CFU B. infantis Rosell®-33 daily or placebo for the first 4 weeks of life, starting on day 1-3 of life. Infants will be followed over 36 weeks with extensive collection of meta-data and samples.

Вмешательства

• Пищевая добавка B. infantis Rosell®-33
  B. infantis Rosell®-33 + maltodextrin
• Пищевая добавка Placebo
  Maltodextrin

Первичные конечные точки

• Gut microbiome [Срок оценки: 4 weeks of age]
• Markers of intestinal inflammation and microbial translocation [Срок оценки: 4 - 36 weeks of age]
• BCG vaccine respone [Срок оценки: 7 weeks of age]
• BCG vaccine respone [Срок оценки: 36 weeks of age]

Вторичные конечные точки (3)

• Longitudinal succession in gut microbiota composition, diversity and function [Срок оценки: 4 - 36 weeks of age]
• Stool metabolome [Срок оценки: 4 weeks of age]
• T cell subsets frequencies [Срок оценки: 4 - 36 weeks of age]

Критерии участия

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

ЮАР · 1 центр

• Khayelitsha Site B Midwife Obstetric Unit — Cape Town

Публикации

• 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 37853370

Идентификаторы

NCT: NCT05923333 · 697/2022 · R01HD109089 · PACTR202301748714019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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