Effects of Goat Milk Formula on Gastrointestinal Comfort and Growth in Infants

A Multicenter, Randomized, Controlled Trial to Evaluate the Effects of Goat Milk Formula on Gastrointestinal Comfort, Behavioral Status, and Early Growth and Development in Infants

Infant gastrointestinal discomfort is common in early life and can affect feeding, sleep, and overall well-being. Goat milk formula, due to its unique protein composition and smaller fat globules, may be easier to digest and potentially improve gastrointestinal tolerance in infants.

This study is a multicenter, randomized, controlled trial designed to evaluate the effects of goat milk formula compared with standard cow milk formula in infants aged 0-5 months with gastrointestinal discomfort. The study will assess improvements in gastrointestinal symptoms, overall comfort, behavioral status, and early growth and development, as well as explore potential changes in gut microbiota and intestinal inflammation.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Gastrointestinal Disorders (FGIDs); Infant Discomfort
• Intervention / Treatment: Dietary supplement: Goat Milk Formula; Dietary supplement: Cow Milk Formula

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinqiong Wang; Phone Number: 021-64370045; Email: wangxq1983@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Infants aged 0 to 5 months at enrollment
• Full-term birth (gestational age ≥37 weeks)
• Birth weight ≥2500 g
• Infants with symptoms of gastrointestinal discomfort (e.g., abdominal distension, excessive crying, regurgitation, or feeding intolerance)
• Parents or legal guardians able and willing to provide written informed consent and comply with study procedures

Exclusion Criteria:

• Infants with known or suspected organic gastrointestinal diseases (e.g., congenital malformations, Hirschsprung disease)
• History of severe perinatal complications or significant systemic diseases
• Known or suspected cow's milk protein allergy or other food allergies
• Use of antibiotics, probiotics, or other medications that may affect gastrointestinal function within 2 weeks prior to enrollment
• Participation in another clinical study within the past 3 months
• Any condition that, in the investigator's judgment, may interfere with study participation or outcome assessment For the reference cohort: healthy breastfed infants without significant gastrointestinal symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goat Milk Formula Group; Infants in this group will be fed with goat milk-based infant formula and receive feeding and care guidance during the study period.	Dietary supplement: Goat Milk Formula; Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
Active Comparator: Cow Milk Formula Group; Infants in this group will continue to receive standard cow milk-based infant formula and receive feeding and care guidance during the study period.	Dietary supplement: Cow Milk Formula; Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
No Intervention: Healthy breastfeeding; No feeding intervention will be performed; only fecal samples and clinical data will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at Day 14	The overall response rate is defined as the proportion of participants in each group showing a ≥30% improvement in ICCS from baseline to Day 14. ICCS is a composite measure combining gastrointestinal symptom burden and behavioral state, with total scores ranging from 0 to 30. Higher scores indicate better overall comfort (better outcome). Response is categorized as: Markedly Effective (improvement ≥50%), Effective (improvement ≥30% to <50%), and Ineffective (improvement <30% or worsening). The overall response rate is calculated as (Markedly Effective + Effective) / Total Cases × 100%.	Baseline to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gastrointestinal Symptom Burden Score	Change in gastrointestinal symptom burden score from baseline to Day 28, assessed using the Infant Gastrointestinal Symptom Assessment Scale. The scale ranges from 0 to 15, with higher scores indicating greater symptom burden (worse outcome).	Baseline to Day 28
Resolution Rate of Individual Gastrointestinal Symptoms	Proportion of infants with complete resolution of individual gastrointestinal symptoms (e.g., abdominal distension, crying, vomiting) by Day 28.	Day 28
Change in Daily Sleep Duration	Change in total daily sleep duration (minutes) based on caregiver-recorded 24-hour infant behavior diary.	Baseline to Day 28
Change in Daily Awake and Content Time	Change in total daily duration of awake and content state as reported by caregivers.	Baseline to Day 28
Change in Parent-Reported Infant Comfort/Feeding Experience	Change from baseline to Day 28 in parent-reported infant comfort experience, assessed using the following instrument: Parenting Feeding and Nurturing Experience Questionnaire total score. This questionnaire consists of 5 items, each scored from 1 to 5, giving a total score range of 5 to 25. Higher scores indicate a more positive parenting and feeding experience (better outcome).	Baseline to Day 28
Change in Parent-Reported Infant Feeding Experience	Change from baseline to Day 28 in parent-reported infant feeding experience, assessed using the following instrument: Visual Analogue Scale (VAS) scores for parent-perceived infant overall comfort, feeding smoothness, and maternal anxiety. Each VAS item ranges from 0 to 10. For all three items, higher scores indicate better outcomes (i.e., more comfort, smoother feeding, and less anxiety).	Baseline to Day 28
Change in Weight-for-Age Z-Score	Change in weight-for-age Z-score from baseline to Day 28. Weight is measured in kilograms (kg) using a calibrated electronic infant scale. The Z-score is a continuous variable (standard deviation units relative to the WHO child growth standard), with a typical clinical range of -3 to +3. Higher Z-scores indicate greater weight for age, generally reflecting better growth outcomes in this population.	Baseline to Day 28
Change in Head Circumference-for-Age Z-Score	Change in head circumference-for-age Z-score from baseline to Day 28. Head circumference is measured in centimeters (cm) using a non-stretchable measuring tape. The Z-score is a continuous variable (standard deviation units relative to the WHO child growth standard), with a typical clinical range of -3 to +3. Higher Z-scores indicate greater head circumference for age, reflecting appropriate brain and cranial growth.	Baseline to Day 28
Change in Length-for-Age Z-Score	Change in length-for-age Z-score from baseline to Day 28. Length is measured in centimeters (cm) using a standard infant length measurement board. The Z-score is a continuous variable (standard deviation units relative to the WHO child growth standard), with a typical clinical range of -3 to +3. Higher Z-scores indicate greater length for age, generally reflecting better growth outcomes in this population.	Baseline to Day 28
Changes in Gut Microbiota Composition	Changes in gut microbiota composition, including relative abundance of key bacterial taxa, assessed by 16S rRNA sequencing of stool samples.	Baseline and Week 4
Change in Fecal Calprotectin Levels	Change in fecal calprotectin concentration as a marker of intestinal inflammation.	Baseline and Week 4

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 14, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 21, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases
• Other Study ID Numbers: GFC2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No