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

ConditionsFunctional Gastrointestinal Disorders (FGIDs)Infant Discomfort
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 5
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Goat Milk Formula

    Dietary supplement

    Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.

  • Cow Milk Formula

    Dietary supplement

    Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Goat Milk Formula GroupExperimental treatment 1 intervention
Group B: Cow Milk Formula GroupActive comparator 1 intervention
Group C: Healthy breastfeedingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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%.

Time frame
Baseline to Day 14

Secondary outcomes

1

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).

Time frame
Baseline to Day 28
2

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.

Time frame
Day 28
3

Change in Daily Sleep Duration

Change in total daily sleep duration (minutes) based on caregiver-recorded 24-hour infant behavior diary.

Time frame
Baseline to Day 28
4

Change in Daily Awake and Content Time

Change in total daily duration of awake and content state as reported by caregivers.

Time frame
Baseline to Day 28

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

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