Healthy InfantsNCT03703583
Infant Feeding Practice and Gut Comfort Study
An observational study of Healthy Infants, run by Société des Produits Nestlé (SPN) at 16 sites in 6 countries.
Trial summary
Multi-country, cross-sectional, observational study in diverse geographic locations all over the world. Read more about this study
- Who is it for?
- Ages 6 weeks to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- How many people
- 2,804 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 9 Oct 2018to 31 Dec 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy normal developing male and female full-term infants
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
Egypt6 sites
Alexandria University
Alexandria
Assuit University
Asyut
Ain Shams University
Cairo
Cairo University
Cairo
Tanta University
Tanta
Zagazig University
Zagazig
Pakistan4 sites
PIMS
Islamabad
National Institute of Child Health
Karachi
The Children Hospital & Institute of Child Health
Lahore
BBH
Rawalpindi
India3 sites
Apollo Children's Hospital
Chennai
ICH Hospital
Kolkata
Dr Praveen Gokhales Childrens Clinic and Vaccination Centre
Thane
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Infants
- Being tested
- There is no intervention in this observational study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in this observational study.Other
There is no intervention in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Exclusively/predominantly Breastfeeding group | Not described Receives: Other: There is no intervention in this observational study. | |
| Exclusively/predominantly Formula feeding group | Not described Receives: Other: There is no intervention in this observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
An index score of overall GI symptom burden
Measured by Validated, standardized infant Gastrointestinal Symptom Questionnaire (IGSQ-13)
Measured: single time point between 6 weeks to 4 months
Secondary outcomes (3)
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))
Measured: single time point between 6 weeks to 4 months
Stool characteristics
measured by Feeding Practice and Gut Comfort Questionnaire (frequency and consistency)
Measured: 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.
Measured: Single time point between 6 weeks to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start9 Oct 2018
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,804 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvan Vandenplas, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703583
- Sponsor's protocol ID
- 17.12.INF
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2018
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36514058
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Feeding Practice and Gut Comfort: a Multi-country, Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT03703583
- Acronym / sponsor ID
- 17.12.INF
- Conditions
- Healthy Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,804 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-country, cross-sectional, observational study in diverse geographic locations all over the world.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 weeks to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy normal developing male and female full-term infants
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention in this observational study.There is no intervention in this observational study. | Other | Exclusively/predominantly Breastfeeding group, Exclusively/predominantly Formula feeding group |
Primary outcome
An index score of overall GI symptom burden
Time frame: single time point between 6 weeks to 4 months
Measured by Validated, standardized infant Gastrointestinal Symptom Questionnaire (IGSQ-13)
3 secondary outcomes
GI Symptoms
Time frame: single time point between 6 weeks to 4 months
Stool characteristics
Time frame: one day recall before study visit
Physician-reported and parent-reported Colic
Time frame: Single time point between 6 weeks to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 36514058Happy 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvan Vandenplas study chair
Universitair Ziekenhuis Brussel
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Infants, run by Société des Produits Nestlé (SPN) at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Egypt, Pakistan, India, Indonesia, Malaysia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An index score of overall GI symptom burden (time frame: single time point between 6 weeks to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.