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

NCT07778927 | Not Yet Recruiting

• 1 other identifier: GFC2026
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Functional Gastrointestinal Disorders (FGIDs); Infant Discomfort

Outcome Measures

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%.

  Baseline to Day 14

Secondary Outcomes (11)

• Change in Gastrointestinal Symptom Burden Score

  Baseline to Day 28

• Resolution Rate of Individual Gastrointestinal Symptoms

  Day 28

• Change in Daily Sleep Duration

  Baseline to Day 28

• Change in Daily Awake and Content Time

  Baseline to Day 28

• Change in Parent-Reported Infant Comfort/Feeding Experience

  Baseline to Day 28

Study Arms (3)

Goat Milk Formula Group

EXPERIMENTAL

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

Cow Milk Formula Group

ACTIVE COMPARATOR

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

Healthy breastfeeding

NO INTERVENTION

No feeding intervention will be performed; only fecal samples and clinical data will be collected.

Interventions

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.

Goat Milk Formula Group

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.

Cow Milk Formula Group

Eligibility Criteria

• Age: Up to 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Xinqiong Wang

CONTACT

021-64370045; wangxq1983@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share