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

NCT07778927 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-08-21

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
5 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-12-31
Completion
2027-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778927 on ClinicalTrials.gov