NCT03703583

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,804

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
6 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

October 4, 2018

Last Update Submit

October 2, 2023

Conditions

Healthy Infants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • GI Symptoms

    single time point between 6 weeks to 4 months

  • Stool characteristics

    one day recall before study visit

  • Physician-reported and parent-reported Colic

    Single time point between 6 weeks to 4 months

Study Arms (2)

Exclusively/predominantly Breastfeeding group

Other: There is no intervention in this observational study.

Exclusively/predominantly Formula feeding group

Other: There is no intervention in this observational study.

Interventions

There is no intervention in this observational study.OTHER

There is no intervention in this observational study.

Exclusively/predominantly Breastfeeding groupExclusively/predominantly Formula feeding group

Eligibility Criteria

Age6 Weeks - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy normal developing male and female full-term infants

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Alexandria University

Alexandria, Egypt

Location

Assuit University

Asyut, Egypt

Location

Ain Shams University

Cairo, Egypt

Location

Cairo University

Cairo, Egypt

Location

Tanta University

Tanta, Egypt

Location

Zagazig University

Zagazig, Egypt

Location

Apollo Children's Hospital

Chennai, India

Location

ICH Hospital

Kolkata, India

Location

Dr Praveen Gokhales Childrens Clinic and Vaccination Centre

Thane, India

Location

Faculty of Medicine Universitas Gadjah Mada

Yogyakarta, Indonesia

Location

University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

PIMS

Islamabad, Pakistan

Location

National Institute of Child Health

Karachi, Pakistan

Location

The Children Hospital & Institute of Child Health

Lahore, Pakistan

Location

BBH

Rawalpindi, Pakistan

Location

St.Luke'S College of Medicine

Quezon City, 1112, Philippines

Location

Related Publications (1)

  • 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.

    PMID: 36514058DERIVED

Study Officials

  • Yvan Vandenplas

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 12, 2018

Study Start

October 9, 2018

Primary Completion

December 30, 2019

Study Completion

December 31, 2019

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

PH(1)IN(3)MY(1)ID(1)EG(6)PA(4)