Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2804 participants
OBSERVATIONAL
2018-10-09
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
NCT01370967
Study in Unsettled Infants Experiencing Feeding Intolerance
NCT02021058
Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk
NCT04768933
Gastrointestinal Tolerance Evaluation of an Infant Formula
NCT03307122
Impact of Infant Formula on Caregiver-perceived Intolerance
NCT03679234
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exclusively/predominantly Breastfeeding group
There is no intervention in this observational study.
There is no intervention in this observational study.
Exclusively/predominantly Formula feeding group
There is no intervention in this observational study.
There is no intervention in this observational study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
There is no intervention in this observational study.
There is no intervention in this observational study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
6 Weeks
4 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yvan Vandenplas
Role: STUDY_CHAIR
Universitair Ziekenhuis Brussel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alexandria University
Alexandria, , Egypt
Assuit University
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
Thāne, , India
Faculty of Medicine Universitas Gadjah Mada
Yogyakarta, , Indonesia
University of Malaya
Kuala Lumpur, , 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, , Philippines
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17.12.INF
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.