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

20 août 2026 mis à jour par: WANG XINQIONG, Ruijin Hospital

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Oui

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Complément alimentaire: Goat Milk Formula
Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
Comparateur actif: 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.
Complément alimentaire: Cow Milk Formula
Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
Aucune intervention: Healthy breastfeeding
No feeding intervention will be performed; only fecal samples and clinical data will be collected.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at Day 14
Délai: 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%.
Baseline to Day 14

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Gastrointestinal Symptom Burden Score
Délai: 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).
Baseline to Day 28
Resolution Rate of Individual Gastrointestinal Symptoms
Délai: Day 28
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
Délai: Baseline to Day 28
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
Délai: Baseline to Day 28
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
Délai: 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).
Baseline to Day 28
Change in Parent-Reported Infant Feeding Experience
Délai: 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).
Baseline to Day 28
Change in Weight-for-Age Z-Score
Délai: 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.
Baseline to Day 28
Change in Head Circumference-for-Age Z-Score
Délai: 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.
Baseline to Day 28
Change in Length-for-Age Z-Score
Délai: 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.
Baseline to Day 28
Changes in Gut Microbiota Composition
Délai: Baseline and Week 4
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
Délai: Baseline and Week 4
Change in fecal calprotectin concentration as a marker of intestinal inflammation.
Baseline and Week 4

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ruijin Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

14 août 2026

Première soumission répondant aux critères de contrôle qualité

20 août 2026

Première publication (Réel)

21 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GFC2026

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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