Infant Feeding Practice and Gut Comfort Study

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Infants
• Intervention / Treatment: Other: There is no intervention in this observational study.

Detailed Description

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 (Actual): 2804

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria University
  • Assiut, Egypt
    • Assuit University
  • Cairo, Egypt
    • Cairo University
  • Cairo, Egypt
    • Ain Shams University
  • Tanta, Egypt
    • Tanta University
  • Zagazig, Egypt
    • Zagazig University
• India
  • Chennai, India
    • Apollo Children's Hospital
  • Kolkata, India
    • ICH Hospital
  • Thāne, India
    • Dr Praveen Gokhales Childrens Clinic and Vaccination Centre
• Indonesia
  • Yogyakarta, Indonesia
    • Faculty of Medicine Universitas Gadjah Mada
• Malaysia
  • Kuala Lumpur, Malaysia, 50603
    • University of Malaya
• Pakistan
  • Islamabad, Pakistan
    • PIMS
  • Karachi, Pakistan
    • National Institute of Child Health
  • Lahore, Pakistan
    • The Children Hospital & Institute of Child Health
  • Rawalpindi, Pakistan
    • BBH
• Philippines
  • Quezon City, Philippines, 1112
    • St.Luke'S College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 4 months (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy normal developing male and female full-term infants

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exclusively/predominantly Breastfeeding group	Other: There is no intervention in this observational study.; There is no intervention in this observational study.
Exclusively/predominantly Formula feeding group	Other: There is no intervention in this observational study.; There is no intervention in this observational study.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Study Chair: Yvan Vandenplas, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17.12.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No