Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multi-country, cross-sectional, observational study in diverse geographic locations all over the world.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusively/predominantly Breastfeeding group |
| ||
| Exclusively/predominantly Formula feeding group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There is no intervention in this observational study. | Other | There is no intervention in this observational study. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Healthy normal developing male and female full-term infants
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yvan Vandenplas | Universitair Ziekenhuis Brussel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Alexandria | Egypt | ||||
| Assuit University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36514058 | Derived | Happy Tummy Consortium; Lavalle L, Sauvageot N, Cercamondi CI, Egli D, Jankovic I, Vandenplas Y. Infant feeding practice and gastrointestinal tolerance: a real-world, multi-country, cross-sectional observational study. BMC Pediatr. 2022 Dec 14;22(1):714. doi: 10.1186/s12887-022-03763-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Asyut |
| Egypt |
| Ain Shams University | Cairo | Egypt |
| Cairo University | Cairo | Egypt |
| Tanta University | Tanta | Egypt |
| Zagazig University | Zagazig | Egypt |
| Apollo Children's Hospital | Chennai | India |
| ICH Hospital | Kolkata | India |
| Dr Praveen Gokhales Childrens Clinic and Vaccination Centre | Thane | India |
| Faculty of Medicine Universitas Gadjah Mada | Yogyakarta | Indonesia |
| University of Malaya | Kuala Lumpur | 50603 | Malaysia |
| PIMS | Islamabad | Pakistan |
| National Institute of Child Health | Karachi | Pakistan |
| The Children Hospital & Institute of Child Health | Lahore | Pakistan |
| BBH | Rawalpindi | Pakistan |
| St.Luke'S College of Medicine | Quezon City | 1112 | Philippines |