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

20. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

150

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Nahrungsergänzungsmittel: Goat Milk Formula
Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
Aktiver Komparator: 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.
Nahrungsergänzungsmittel: Cow Milk Formula
Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
Kein Eingriff: Healthy breastfeeding
No feeding intervention will be performed; only fecal samples and clinical data will be collected.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at Day 14
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Gastrointestinal Symptom Burden Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and Week 4
Change in fecal calprotectin concentration as a marker of intestinal inflammation.
Baseline and Week 4

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ruijin Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

14. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. August 2026

Zuerst gepostet (Tatsächlich)

21. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GFC2026

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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