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Completed

NCT Number: NCT03703583

Infant Feeding Practice and Gut Comfort Study

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

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Key information

Conditions

Healthy Infants

Age range

6 week–4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria University, Alexandria, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

There is no intervention in this observational study.

Other

There is no intervention in this observational study.

Primary outcomes

  1. 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)

Secondary outcomes

  1. GI Symptoms

    Time frame: single time point between 6 weeks to 4 months

    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))

  2. Stool characteristics

    Time frame: one day recall before study visit

    measured by Feeding Practice and Gut Comfort Questionnaire (frequency and consistency)

  3. Physician-reported and parent-reported Colic

    Time frame: Single time point between 6 weeks to 4 months

    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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 12, 2018
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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