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Infant Feeding Practice and Gut Comfort Study

N

Nestlé

Status

Completed

Conditions

Healthy Infants

Treatments

Other: There is no intervention in this observational study.

Study type

Observational

Funder types

Industry

Identifiers

NCT03703583
17.12.INF

Details and patient eligibility

About

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

Full 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.

Enrollment

2,804 patients

Sex

All

Ages

6 weeks to 4 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

2,804 participants in 2 patient groups

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

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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