Infant Feeding Practice and Gut Comfort Study

Healthy Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703583
• Other study ID #: 17.12.INF
• Status: Completed
• Start date: October 9, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2804
• Est. completion date: December 31, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Other:
• There is no intervention in this observational study.
There is no intervention in this observational study.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Countries where clinical trial is conducted

Egypt,  India,  Indonesia,  Malaysia,  Pakistan,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Stool characteristics	measured by Feeding Practice and Gut Comfort Questionnaire (frequency and consistency)	one day recall before study visit
Secondary	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