Functional Gastrointestinal Disorders (FGIDs), Infant Discomfort
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGoat Milk Formula
Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
DIETARY_SUPPLEMENTCow Milk Formula
Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at Day 14 | Baseline to 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Symptom Burden Score | Baseline to Day 28 | 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). |
| Resolution Rate of Individual Gastrointestinal Symptoms | Day 28 | Proportion of infants with complete resolution of individual gastrointestinal symptoms (e.g., abdominal distension, crying, vomiting) by Day 28. |
| Change in Daily Sleep Duration | Baseline to Day 28 | Change in total daily sleep duration (minutes) based on caregiver-recorded 24-hour infant behavior diary. |
| Change in Daily Awake and Content Time | Baseline to Day 28 | Change in total daily duration of awake and content state as reported by caregivers. |
| Change in Parent-Reported Infant Comfort/Feeding Experience | Baseline to Day 28 | 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). |
| Change in Parent-Reported Infant Feeding Experience | Baseline to Day 28 | 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). |
| Change in Weight-for-Age Z-Score | Baseline to Day 28 | 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. |
| Change in Head Circumference-for-Age Z-Score | Baseline to Day 28 | 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. |
| Change in Length-for-Age Z-Score | Baseline to Day 28 | 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. |
| Changes in Gut Microbiota Composition | Baseline and Week 4 | Changes in gut microbiota composition, including relative abundance of key bacterial taxa, assessed by 16S rRNA sequencing of stool samples. |
| Change in Fecal Calprotectin Levels | Baseline and Week 4 | Change in fecal calprotectin concentration as a marker of intestinal inflammation. |
Contacts
CONTACTXinqiong Wang
Outcome results
None listed