Efficacy of Two HMOs in Chinese Infants

Официальное название

Efficacy of a Ready to Feed (RTF) Starter Liquid Infant Formula Containing 2'FL and LNnT in Chinese Infants: A Double-blind, Randomized Controlled Trial Including a Breastfed Reference Group

Обзор

This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.

Вмешательства

• Другое Experimental Group (EG)
  Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).
• Другое Control Group (CG)
  Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).

Первичные конечные точки

• Bifidobacteria abundance in fecal samples [Срок оценки: just prior to 3 months of age]

Вторичные конечные точки (12)

• Gut microbiota composition [Срок оценки: From enrollment until 12 months of age]
• Fecal metabolism [Срок оценки: From enrollment until 12 months of age]
• Fecal metabolism [Срок оценки: From enrollment until 12 months of age]
• Fecal markers of intestinal immune health [Срок оценки: From enrollment until 6 months of age]
• Fecal markers of gut barrier function [Срок оценки: From enrollment until 6 months of age]
• Fecal markers of gut barrier function [Срок оценки: From enrollment until 6 months of age]
• Fecal markers of gut barrier function [Срок оценки: From enrollment until 6 months of age]
• Fecal markers of inflammation [Срок оценки: From enrollment until 6 months of age]
• Fecal markers of inflammation [Срок оценки: From enrollment until 6 months of age]
• Fecal markers of inflammation [Срок оценки: From enrollment until 6 months of age]
• Stool patterns [Срок оценки: From enrollment until 14 days]
• Stool patterns [Срок оценки: From enrollment until 12 months of age]

Критерии участия

Критерии включения

• Healthy male and female infants of post-natal age of 3-14 days (date of birth = day 0), inclusive, at enrolment
• Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the trial.
• Infants whose parent(s) have reached the legal age of majority in China.
• Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the trial protocol.
• Infants whose parent(s)/LAR can be contacted directly by telephone throughout the trial.
• Infants whose parent(s)/LAR have a working freezer.
• Singleton, healthy, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
• For the formula-fed groups: infant is exclusively consuming and tolerating a cow' s milk infant formula for at least 3 days prior to enrolment. The infant's mother has independently elected not to breastfeed.
• For the breastfed reference group: infant has been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established) and the infant's mother has made the decision to continue exclusively breastfeeding until at least 3 months of age.

Критерии исключения

• Infants with conditions requiring infant feedings other than those specified in the protocol.
• Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrolment.
• Infants who have a medical condition or history that could increase the risk associated with trial participation or interfere with the interpretation of trial results, including: Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). Documented or suspected systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis). Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the trial.
• Infants who are presently receiving or have received prior to enrolment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics and microbiota (e.g., oral and systemic antibiotics, glycerine suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
• Currently participating or having participated in another clinical trial since birth.
• Infant who has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy.

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

Другое

Центры проведения

Китай · 1 центр

• The International Peace Maternity & Child Health Hospital of China Welfare Institute — Шанхай

Публикации

• Wang Y, Le Roy CI, Li J, Han S, Liu Z, Lahiry A, Sahu H, Li Q, Dong J, Mondragon A, Samuel TM, Cai W. Efficacy of a Ready-to-Feed Starter Liquid Infant Formula Containing 2-Fucosyllactose and Lacto-N-Neotetraose in Chinese Infants: Protocol for a Double Blind, Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 31;14:e66489. doi: 10.2196/66489. PMID 41172301

Идентификаторы

NCT: NCT06361719 · 2312INF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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