Infant Feeding Practice and Gut Comfort Study

Study Overview
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Brief Summary
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Multi-country, cross-sectional, observational study in diverse geographic locations all over the world.

Detailed Description
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This is a cross-sectional single time point study. Infants and caregivers who come to a clinic for a routine health visit who wish to participate in the study by signing the consent form and meet all inclusion criteria/exclusion criteria will be enrolled. At the visit, a research staff member will assist the parents to complete (i) Feeding Practice and Gut Comfort Questionnaire and (ii) Infant Gastrointestinal Symptom (IGSQ)-13 items. Additionally, infant's anthropometrics (weight, length, head circumference) will be recorded. These anthropometrics will be measured by the researcher as part of the routine visit.

Official Title
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Infant Feeding Practice and Gut Comfort: a Multi-country, Cross-sectional Observational Study

Conditions
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Healthy Infants

Intervention / Treatment
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* Other: There is no intervention in this observational study.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy full term (37-42 weeks of gestation) singleton infant. Postnatal age ≥ 6 weeks and ≤ 4 months Parent as primary Caregiver and ≥ 18 years old Exclusively/predominantly breastfeeding or exclusively/predominantly formula feeding of the same type/brand, for at least the past 2 weeks. Evidence of personally signed and dated informed consent document by the infant's parent(s). Exclusion Criteria: Chronic illness necessitating medical follow up Acute ongoing or recent (last 2 weeks) illness necessitating medical follow up Any known case of food allergy (e.g milk) Caregivers who are not likely to comply with the study procedures

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exclusively/predominantly Breastfeeding group<br> | Other: There is no intervention in this observational study.<br>* There is no intervention in this observational study.<br>|
| Exclusively/predominantly Formula feeding group<br> | Other: There is no intervention in this observational study.<br>* There is no intervention in this observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An index score of overall GI symptom burden | Measured by Validated, standardized infant Gastrointestinal Symptom Questionnaire (IGSQ-13) | single time point between 6 weeks to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI Symptoms | measured by IGSQ-13 questionnaires (An overall index score is calculated from 13 questions in the questionnaire as a measure of total GI symptom burden. The values for the IGSQ index score can range from 13 (low GI burden) to 65 (high GI burden)) | single time point between 6 weeks to 4 months | 
| Stool characteristics | measured by Feeding Practice and Gut Comfort Questionnaire (frequency and consistency) | one day recall before study visit | 
| Physician-reported and parent-reported Colic | measured by Feeding Practice and Gut Comfort Questionnaire based on ROME IV diagnosis criteria. Effect of feeding group on the prevalence of colic will be assessed by logistic regression. | Single time point between 6 weeks to 4 months |