Functional Gastrointestinal Disorders (FGIDs)NCT07778927
Effects of Goat Milk Formula on Gastrointestinal Comfort and Growth in Infants
A study testing Goat Milk Formula and Cow Milk Formula in people with Functional Gastrointestinal Disorders (FGIDs) and Infant Discomfort, run by Ruijin Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders (FGIDs), Infant Discomfort
- What is being tested?
- Goat Milk Formula and Cow Milk Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Goat Milk Formula, Cow Milk Formula
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goat Milk FormulaDietary supplement
Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
Cow Milk FormulaDietary supplement
Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Cow Milk Formula |
| Healthy breastfeeding | No intervention | No feeding intervention will be performed; only fecal samples and clinical data will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline to Day 14
Secondary outcomes (11)
Change in Gastrointestinal Symptom Burden Score
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).
Measured: Baseline to Day 28
Resolution Rate of Individual Gastrointestinal Symptoms
Proportion of infants with complete resolution of individual gastrointestinal symptoms (e.g., abdominal distension, crying, vomiting) by Day 28.
Measured: Day 28
Change in Daily Sleep Duration
Change in total daily sleep duration (minutes) based on caregiver-recorded 24-hour infant behavior diary.
Measured: Baseline to Day 28
Change in Daily Awake and Content Time
Change in total daily duration of awake and content state as reported by caregivers.
Measured: Baseline to Day 28
Change in Parent-Reported Infant Comfort/Feeding Experience
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).
Measured: Baseline to Day 28
Change in Parent-Reported Infant Feeding Experience
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).
Measured: Baseline to Day 28
Change in Weight-for-Age Z-Score
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.
Measured: Baseline to Day 28
Change in Head Circumference-for-Age Z-Score
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.
Measured: Baseline to Day 28
Change in Length-for-Age Z-Score
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.
Measured: Baseline to Day 28
Changes in Gut Microbiota Composition
Changes in gut microbiota composition, including relative abundance of key bacterial taxa, assessed by 16S rRNA sequencing of stool samples.
Measured: Baseline and Week 4
Change in Fecal Calprotectin Levels
Change in fecal calprotectin concentration as a marker of intestinal inflammation.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal Disorders (FGIDs)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG XINQIONG, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778927
- Sponsor's protocol ID
- GFC2026
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07778927
- Acronym / sponsor ID
- GFC2026
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Goat Milk Formula Group | Experimental | Dietary Supplement: Goat Milk FormulaInfants in this group will be fed with goat milk-based infant formula and receive feeding and care guidance during the study period. |
| Cow Milk Formula Group | Active comparator | Dietary Supplement: Cow Milk FormulaInfants in this group will continue to receive standard cow milk-based infant formula and receive feeding and care guidance during the study period. |
| Healthy breastfeeding | No intervention | –No feeding intervention will be performed; only fecal samples and clinical data will be collected. |
Who may qualify
- Ages
- Up to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goat Milk FormulaInfants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices. | Dietary supplement | Goat Milk Formula Group |
| Cow Milk FormulaInfants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices. | Dietary supplement | Cow Milk Formula Group |
Primary outcome
Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at Day 14
Time frame: 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%.
11 secondary outcomes
Change in Gastrointestinal Symptom Burden Score
Time frame: Baseline to Day 28
Resolution Rate of Individual Gastrointestinal Symptoms
Time frame: Day 28
Change in Daily Sleep Duration
Time frame: Baseline to Day 28
Change in Daily Awake and Content Time
Time frame: Baseline to Day 28
Change in Parent-Reported Infant Comfort/Feeding Experience
Time frame: Baseline to Day 28
Change in Parent-Reported Infant Feeding Experience
Time frame: Baseline to Day 28
Change in Weight-for-Age Z-Score
Time frame: Baseline to Day 28
Change in Head Circumference-for-Age Z-Score
Time frame: Baseline to Day 28
Change in Length-for-Age Z-Score
Time frame: Baseline to Day 28
Changes in Gut Microbiota Composition
Time frame: Baseline and Week 4
Change in Fecal Calprotectin Levels
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Goat Milk Formula and Cow Milk Formula in people with Functional Gastrointestinal Disorders (FGIDs) and Infant Discomfort, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinqiong Wang (021-64370045, wangxq1983@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at Day 14 (time frame: Baseline to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.