An interventional study of Goat Milk Formula and Cow Milk Formula in Functional Gastrointestinal Disorders (FGIDs) and Infant Discomfort, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged Up to 5 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Supportive care
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants in this group will be fed with goat milk-based infant formula and receive feeding and care guidance during the study period.
Dietary Supplement: Goat Milk Formula
Infants in this group will continue to receive standard cow milk-based infant formula and receive feeding and care guidance during the study period.
Dietary Supplement: Cow Milk Formula
No feeding intervention will be performed; only fecal samples and clinical data will be collected.
Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
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%.
Time frame: Baseline to Day 14
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).
Time frame: 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.
Time frame: Day 28
Change in Daily Sleep Duration
Change in total daily sleep duration (minutes) based on caregiver-recorded 24-hour infant behavior diary.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 4
Change in Fecal Calprotectin Levels
Change in fecal calprotectin concentration as a marker of intestinal inflammation.
Time frame: Baseline and Week 4
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 127 non-industry interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 16 months is below that.
Counting every sponsor, half of 149 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.