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Malnutrition (Calorie)GMDFANCT07225153

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

A study testing GMDFA and Undiluted Goat Milk in people with Malnutrition (Calorie) and Infant Nutrition Disorder, run by Aga Khan University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 8 to 10 weeks
What is being tested?
GMDFA and Undiluted Goat Milk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 sitePakistan
Study dates
30 Aug 2025to 18 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 10 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • • 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

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nimra Mazhar, M.Phil contact

+923012354157

nimra.mazhar@scholar.aku.edu

Pakistan1 site, 1 recruiting

  • MATIARI Research & Training Centre

    Matiāri, Sindh, 45330

    Dr. Fayyaz Umrani, MSPH, +923337009960, fayaz.umrani@aku.edu

    Dr. Sheraz Ahmed, +923343131087, sheraz.ahmed@aku.edu

    Recruiting

Other trials in Pakistan

About this study

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

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:

Read more
  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

Read the detailed description

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.

Being tested
GMDFA, Undiluted Goat Milk
Keywords
Infant nutrition, goat milk, Infant feeding practices, Breastfeeding, Breastfeeding Alternatives, Alternate feeding practices, Growth outcomes, Infant growth metrics, Gut microbiome, Gut inflammation biomarkers, Calprotectin, Lipocalin-2, Claudin-2, C-reactive protein (CRP), Randomized controlled trial, Rural Pakistan, Infant health, Malnutrition prevention, Lipidomics, Breast milk
Medical subject headings
Malnutrition, Infant Nutrition Disorders, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GMDFADietary supplement

    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.

  • Undiluted Goat MilkOther

    Infants will receive undiluted goat milk as per current local feeding practices for 8 weeks.

Study groups in NCT07225153
Study groupRoleWhat they receive
Goat Milk-Derived Formula Alternative (GMDFA)ExperimentalInfants in this arm will receive Goat Milk-Derived Formula Alternative (GMDFA) as their primary source of feeding for 08 weeks. Growth, safety, and biological markers will be assessed through anthropometric measurements and laboratory analyses, including microbiome, metagenomic, and lipidomic profiling.
Receives: Dietary Supplement: GMDFA
Undiluted Goat Milk (Current Practice)Active comparatorInfants in this arm will receive undiluted goat milk according to local feeding practices, representing the current alternative to breastfeeding in the community. Growth and biological markers will be compared with the GMDFA and breastfed groups to evaluate safety and nutritional adequacy.
Receives: Other: Undiluted Goat Milk
Breastfed Group (Reference Comparator)No interventionInfants in this arm will be exclusively breastfed following WHO guidelines. No feeding intervention will be introduced. This group serves as the gold standard for comparison of growth metrics, microbiome composition, and metabolic biomarkers with the GMDFA and undiluted goat milk groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in lipidomic markers among infants receiving Goat Milk-Derived Formula Alternative (GMDFA) compared to undiluted goat milk and breastfeeding groups.

    To evaluate whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive GMDFA show favorable changes in lipidomic profiles compared to those fed undiluted goat milk, and similar metabolic marker status compared to exclusively breastfed infants after 8 weeks of intervention.

    Measured: Baseline (enrollment) to 8 weeks after intervention

  2. Change in gut microbiome composition and diversity among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups.

    To determine whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive Goat Milk-Derived Formula Alternative (GMDFA) exhibit distinct shifts in gut microbiome composition (Bifidobacterium, Firmicutes, Bacteroides, Clostridium, and Lactobacillus) and changes in alpha- and beta-diversity over 8 weeks, compared to those fed undiluted goat milk, and a microbiome profile similar to age-matched breastfed infants and healthy reference profiles from the same population.

    Measured: Baseline (enrollment) to 8 weeks after intervention

Secondary outcomes (3)

  1. Infant growth measured by weight-for-age z-score (WAZ)

    Change in infant weight-for-age z-score from enrollment to 16-18 weeks of age, comparing GMDFA, breastfeeding, and undiluted goat milk groups.

    Measured: From baseline (enrollment) to 16-18 weeks of age

  2. Change in serum micronutrient levels among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups.

    To determine whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive Goat Milk-Derived Formula Alternative (GMDFA) exhibit higher serum concentrations of essential micronutrients (vitamin A, vitamin B12, vitamin D, calcium, iron, and zinc) compared to those fed undiluted goat milk, and comparable micronutrient status to exclusively breastfed infants after 8 weeks of intervention.

    Measured: Baseline (enrollment) to 8 weeks after intervention

  3. Change in gut inflammatory biomarkers among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups.

    To assess whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive Goat Milk-Derived Formula Alternative (GMDFA) show favorable changes in gut inflammatory markers (CRP, Lipocalin-2, Claudin, and Calprotectin) compared to those fed undiluted goat milk, and similar gut inflammatory marker status to exclusively breastfed infants after 8 weeks of intervention.

    Measured: Baseline (enrollment) to 8 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2025
  2. Study start30 Aug 2025
  3. Primary completion30 Dec 2025
  4. Study completion18 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a three-arm, parallel-group, community-based randomized controlled trial designed to compare the effects of Goat Milk-Derived Formula Alternative (GMDFA), undiluted goat milk, and exclusive breastfeeding on infant growth, gut microbiome, and metabolic health. Infants will be randomly assigned to one of the three groups and followed concurrently for a 8-week intervention period. Each group will receive its assigned feeding regimen in parallel, with no crossover between groups.
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07225153
Sponsor's protocol ID
2025-11220-34303
Other IDs
D43TW007585, 2025
Acronym
GMDFA
Status last verified
Mar 2026
First submitted
4 Nov 2025
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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 2023.

    PubMed 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. Nutrients. 2022 Jan 26;14(3):530. doi: 10.3390/nu14030530.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 32422857

  • Organization, W. H. (2005). Guiding principles for feeding non-breastfed children 6-24 months of age, World Health Organization.

  • Organization, W. H. (2003). Complementary feeding: report of the global consultation, and summary of guiding principles for complementary feeding of the breastfed child, World Health Organization.

  • Noh JW, Kim YM, Akram N, Yoo KB, Cheon J, Lee LJ, Kwon YD, Stekelenburg J. Factors Affecting Breastfeeding Practices in Sindh Province, Pakistan: A Secondary Analysis of Cross-Sectional Survey Data. Int J Environ Res Public Health. 2019 May 14;16(10):1689. doi: 10.3390/ijerph16101689.

    PubMed 31091768

  • Nayik GA, Jagdale YD, Gaikwad SA, Devkatte AN, Dar AH, Dezmirean DS, Bobis O, Ranjha MMAN, Ansari MJ, Hemeg HA, Alotaibi SS. Recent Insights Into Processing Approaches and Potential Health Benefits of Goat Milk and Its Products: A Review. Front Nutr. 2021 Dec 6;8:789117. doi: 10.3389/fnut.2021.789117. eCollection 2021.

    PubMed 34938763

  • Militao, E. M., Salvador, E. M., Silva, J. P., Uthman, O. A., Vinberg, S., & Macassa, G. (2022). Coping strategies for household food insecurity, and perceived health in an urban community in southern Mozambique: a qualitative study. Sustainability, 14(14), 8710.

  • Kinsella HM, Hostnik LD, Toribio RE. Energy endocrine physiology, pathophysiology, and nutrition of the foal. J Am Vet Med Assoc. 2022 Oct 26;260(S3):S83-S93. doi: 10.2460/javma.22.08.0348.

    PubMed 36288202

  • Kandhro F, Kazi TG, Afridi HI, Baig JA, Lashari AA, Lashari A. Determination of toxic elemental levels in whey milk of different cattle and human using an innovative digestion method: risk assessment for children < 6.0 months to 5 years. Environ Sci Pollut Res Int. 2023 Mar;30(14):41923-41936. doi: 10.1007/s11356-022-25059-1. Epub 2023 Jan 14.

    PubMed 36640239

  • Kabir F, Iqbal J, Jamil Z, Iqbal NT, Mallawaarachchi I, Aziz F, Kalam A, Muneer S, Hotwani A, Ahmed S, Umrani F, Syed S, Sadiq K, Ma JZ, Moore SR, Ali A. Impact of enteropathogens on faltering growth in a resource-limited setting. Front Nutr. 2023 Jan 10;9:1081833. doi: 10.3389/fnut.2022.1081833. eCollection 2022.

    PubMed 36704796

Questions about this trial

What is this clinical trial studying?

A study testing GMDFA and Undiluted Goat Milk in people with Malnutrition (Calorie) and Infant Nutrition Disorder, run by Aga Khan University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nimra Mazhar, M.Phil (+923012354157, nimra.mazhar@scholar.aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in lipidomic markers among infants receiving Goat Milk-Derived Formula Alternative (GMDFA) compared to undiluted goat milk and breastfeeding groups. (time frame: Baseline (enrollment) to 8 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07225153, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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