Infant Feeding Practice and Gut Comfort Study

Société des Produits Nestlé (SPN)2,804 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,804

Conditions

Healthy Infants

Interventions

There is no intervention in this observational study.OTHER

There is no intervention in this observational study.

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 4 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (16)

Alexandria University

Alexandria, Egypt

Assuit University

Asyut, Egypt

Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

An index score of overall GI symptom burden

Measured by Validated, standardized infant Gastrointestinal Symptom Questionnaire (IGSQ-13)

Time frame: single time point between 6 weeks to 4 months

Secondary Outcomes

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))

Time frame: single time point between 6 weeks to 4 months

Stool characteristics

measured by Feeding Practice and Gut Comfort Questionnaire (frequency and consistency)

Time frame: 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.

Time frame: Single time point between 6 weeks to 4 months

Data from ClinicalTrials.gov

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