Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.

Официальное название

A Double-blind Randomised Controlled Study to Investigate the Effect of a follow-on Formula With a Specific Synbiotic Mixture on the Gut Microbiota Composition in Healthy Infants.

Обзор

This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Infants will be randomly assigned to receive either the test or control product. Growth and health data will be collected during study visits. Parents will collect stool samples and complete diaries to help researchers better understand the baby's digestion and overall health. A follow-up phone call will be made to check on the baby's well-being after the study ends.

Вмешательства

• Другое Test: Follow-on formula with synbiotics
  Intervention description: both products are nutritionally complete follow-on formulas
• Другое Control: Regular follow-on formula
  Intervention description: both products are nutritionally complete follow-on formulas

Первичные конечные точки

• Bifidobacteria proportions [Срок оценки: Baseline and 12 weeks postbaseline]

Критерии участия

Критерии включения

• Healthy infants as per the clinical judgement of the Investigator
• Singleton infants
• Infants ≥6 months and ≤9 months of age at Visit 1
• Infant's weight-for-age WHO z-score within ± 2 SD at Visit 1
• Infants fed with an infant or follow-on formula at Visit 1.
• Infants are familiar with, and are expected to drink, ≥600 mL formula per day.
• Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at Visit 1.

Критерии исключения

• Infants with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances
• Infants who received breastfeeding ≤14 days before Visit 1
• Infants who are potty-trained
• Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
• Use of medication or nutritional products/food supplements known to impact the study outcomes ≤14 days before Visit 1 or expected need during the study.
• Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
• Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements, including access to a phone.
• Children of employees and/or family members or relatives of employees of Danone, the participating sites, or any other nutrition company that develops infant, follow-on or young child formulae.

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

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Индонезия · 2 центра

• DPS_RSUP Prof. Dr. I.G.N.G. Ngoerah — Denpasar
• SBY_RSUD Dr. Soetomo — Surabaya

Идентификаторы

NCT: NCT07207109 · 24REX0075490

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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