Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis

Официальное название

Goat Milk-Derived Formula Alternatives vs. Undiluted Goat Milk in Babies Unable to Exclusively Breastfeed: Analysis of Growth Metrics and Biological Markers

Обзор

The goal of this clinical trial is to learn if Goat Milk-Derived Formula Alternatives (GMDFA) are safe and effective for infants who are unable to be exclusively breastfed. It will also study growth patterns, biological markers, and gut microbiome differences among infants receiving GMDFA, undiluted goat milk, or breast milk. The main questions it aims to answer are: 1. Do infants receiving GMDFA show similar growth patterns to those who are breastfed? 2. Are biological markers of gut health and nutrition (such as calprotectin, lipocalin-2, CRP, and claudin) comparable between the groups? 3. How do feeding types (GMDFA, goat milk, or breast milk) influence the infant gut microbiome composition, metabolic pathways, and lipid profiles? 4. Is GMDFA a safe and nutritionally adequate feeding option for infants unable to be exclusively breastfed? We will compare GMDFA, undiluted goat milk, and breast milk (reference group) to evaluate infant growth, gut health, and metabolic outcomes. Participants will: Be randomly assigned to one of three feeding groups: GMDFA, undiluted goat milk, or breastfed Attend regular follow-up visits for growth measurements and sample collection (blood, stool, and breast milk where applicable) Have feeding practices monitored and recorded through caregiver interviews and feeding logs Additional Analyses: Microbiome analysis: to identify gut bacterial diversity and composition across feeding groups Metagenomic analysis: to explore functional genes and metabolic pathways related to nutrition and gut health Lipidomic analysis: to assess differences in lipid and fatty acid profiles in breast milk, goat milk, and infant samples

Подробное описание

This community-based randomized controlled trial will evaluate the safety, nutritional adequacy, and biological effects of a Goat Milk-Derived Formula Alternative (GMDFA) among infants aged 8-10 weeks in Matiari, Pakistan, who are unable to exclusively breastfeed. The study includes three groups: (1) an intervention group receiving GMDFA prepared according to a standardized recipe developed for the study, (2) a control group receiving undiluted goat milk according to local feeding practices, and (3) an active comparator group of exclusively breastfed infants serving as a reference.

The intervention will last for 8 weeks. Primary and secondary outcomes will assess changes in lipidomic profiles, micronutrient status, gut inflammatory biomarkers (CRP, lipocalin-2, calprotectin, Claudin), and gut microbiome composition and diversity (Bifidobacterium, Firmicutes, Bacteroides, Clostridium, Lactobacillus). Anthropometric measurements including weight, length, and head circumference will be recorded at baseline and follow-up to evaluate infant growth outcomes.

The study aims to determine whether GMDFA provides a safe and nutritionally appropriate alternative to formula milk for infants who cannot be exclusively breastfed, with comparable biological and growth outcomes to breastfed infants. Findings from this study will inform the potential use of goat milk-based alternatives in low-resource settings where malnutrition and suboptimal breastfeeding rates are prevalent.

Вмешательства

• Пищевая добавка GMDFA
  GMDFA (GOat Milk-Derived Formula Alternative) is a goat milk-based formulation designed as an affordable alternative to commercial infant formula. It is prepared by diluting goat's milk to a standardized protein and micronutrient concentration according to study protocol. Infants in this arm will receive GMDFA from enrollment (08-10 weeks) until 16-18 weeks of age under close monitoring for growth and safety outcomes.
• Другое Undiluted Goat Milk
  Infants will receive undiluted goat milk as per current local feeding practices for 8 weeks.

Первичные конечные точки

• Change in lipidomic markers among infants receiving Goat Milk-Derived Formula Alternative (GMDFA) compared to undiluted goat milk and breastfeeding groups. [Срок оценки: Baseline (enrollment) to 8 weeks after intervention]
• Change in gut microbiome composition and diversity among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups. [Срок оценки: Baseline (enrollment) to 8 weeks after intervention]

Вторичные конечные точки (3)

• Infant growth measured by weight-for-age z-score (WAZ) [Срок оценки: From baseline (enrollment) to 16-18 weeks of age]
• Change in serum micronutrient levels among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups. [Срок оценки: Baseline (enrollment) to 8 weeks after intervention]
• Change in gut inflammatory biomarkers among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups. [Срок оценки: Baseline (enrollment) to 8 weeks after intervention]

Критерии участия

Критерии включения

• • Infants aged = 08 -10 weeks with WAZ better than -1.8. (NIPS \& ICF, 2019) Age Sex WAZ Weight in Kilograms 2 Month Boys WAZ>-1.8 4-5 kg 2 Month Girls WAZ>-1.8 4-5 kg Table 3: WAZ scores

• Living in Matiari District.
• Who has access to goat milk in their households.
• The Breastfeeding group: Women who exclusively breastfeeding and not giving and sort of formula or animal derived milk.
• Intervention Group: Women who do not breastfeed at all or give goat milk to their infants (2-3 feeds per day).
• No birth deformities

Критерии исключения

• • Infant birth weight < WAZ -1.8 i.e. weight-for-age based on established growth standards, such as the World Health Organization (WHO).

• Birth deformities or disorders, such as genetic disorders, aerodigestive problems, or congenital anomalies.
• Plan to migrate during the next six months.
• We will exclude the women who exclusive breast feed and continue breast feeding for first 4 months.
• If the child is enrolled or included in any other interventional trial.
• Who does not have access to goat milk in their households.
• Are medically disqualified: Any potential participant who is deemed medically unfit for enrollment, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Пакистан · 1 центр

• MATIARI Research & Training Centre — Matiāri

Публикации

• George AD, Paul S, Wang T, Huynh K, Giles C, Mellett N, Duong T, Nguyen A, Geddes D, Mansell T, Saffery R, Vuillermin P, Ponsonby AL, Burgner D, Burugupalli S, Meikle PJ; Barwon Infant Study Investigator Team. Defining the lipid profiles of human milk, infant formula, and animal milk: implications for infant feeding. Front Nutr. 2023 Aug 30;10:1227340. doi: 10.3389/fnut.2023.1227340. eCollection 2 PMID 37712002
• Vandenplas Y, Zolnowska M, Berni Canani R, Ludman S, Tengelyi Z, Moreno-Alvarez A, Goh AEN, Gosoniu ML, Kirwan BA, Tadi M, Heine RG, Cinnamon Study Investigator Group. Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow's Milk Protein Allergy: A Randomized, Multi-Center Trial. Nutrient PMID 35276889
• Akter S, Nishu NA. Malnutrition among under-5 children and its determinants in the southwestern coastal region of Bangladesh: A community-based study. BMJ Open. 2025 Jan 14;15(1):e090174. doi: 10.1136/bmjopen-2024-090174. PMID 39809564
• Moreno-Avila IDM, Martinez-Linares JM, Garcia-Pintor S, Rubia-Ortega SM, Ortiz-Paneque J, El Messaoudi-Ouardani S, Cortes-Martin J. Perceptions on the Reasons Influencing the Choice and Abandonment of Exclusive Breastfeeding in Muslim and Christian Women: A Phenomenological Study. Nurs Health Sci. 2025 Sep;27(3):e70195. doi: 10.1111/nhs.70195. PMID 40695358
• Reinhardt K, Fanzo J. Addressing Chronic Malnutrition through Multi-Sectoral, Sustainable Approaches: A Review of the Causes and Consequences. Front Nutr. 2014 Aug 15;1:13. doi: 10.3389/fnut.2014.00013. eCollection 2014. PMID 25988116
• Omer S, Zakar R, Zakar MZ, Fischer F. The influence of social and cultural practices on maternal mortality: a qualitative study from South Punjab, Pakistan. Reprod Health. 2021 May 18;18(1):97. doi: 10.1186/s12978-021-01151-6. PMID 34006307
• Pietrzak-Fiecko R, Kamelska-Sadowska AM. The Comparison of Nutritional Value of Human Milk with Other Mammals' Milk. Nutrients. 2020 May 14;12(5):1404. doi: 10.3390/nu12051404. PMID 32422857
• Organization, W. H. (2005). Guiding principles for feeding non-breastfed children 6-24 months of age, World Health Organization.

Идентификаторы

NCT: NCT07225153 · 2025-11220-34303 · D43TW007585

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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