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OpenTrials
Completed

NCT Number: NCT02598817

Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula

The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.

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Key information

Conditions

Infant Term Birth

Age range

2 week–12 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Tadawi General Hospital, Dammam, Saudi Arabia

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About this study

This is a multicenter, open label, observation study; 500 formula fed infants are planned to be enrolled from a network of general pediatricians in the Gulf countries (UAE, Kuwait, Qatar, and KSA). Eligible infants will consume a high sn-2 palmitate infant formula for 12 weeks. All enrolled infants will be evaluated at enrollment and at 4 weeks and 12 weeks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Formula fed healthy full term infants with normal birth weight (2500g 4000g)
  • Partially breast and formula fed infants who drink at least 2 formula feedings per day; each to be at least 30ml
  • Infants of both genders at age of 2 weeks to 12 weeks
  • Infants of parents providing written informed consent before any study related activities are carried out

Exclusion criteria

  • Preterm or IUGR babies
  • Contraindication of standard infant formula
  • Infants who have allergy of cow's milk protein
  • Infants with Serious medical or surgical GI disease
  • Infants with multiple congenital anomalies
  • Infants with suspected chromosomal or metabolic disorder
  • Infants of mothers with a health condition or socioeconomic problems that may interfere with their ability to take care of their infants
  • Infants of parents who refuse to participate in the study

Treatment and study plan

Standard Infant Formula

Other

Standard Infant Formula containing High Sn-2

Primary outcomes

  1. Infant Stool Form Scale

    Time frame: 12 weeks

    frequency and consistency

Secondary outcomes

  1. Changes from baseline to 12 weeks in Height centile

    Time frame: 12 weeks

    height (cm)

  2. Changes from baseline to 12 weeks in Weight centile

    Time frame: 12 weeks

    weight(kg) and respective Wt z-scores

  3. Changes from baseline to 12 weeks in Head Circumference centile

    Time frame: 12 weeks

    Head circumference (cm)

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Acceptability of "High Sn-2" Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician. An Open Label Pilot Study Evaluation in the Gulf Cooperation Council (GCC) Countries.

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 6, 2015
Registry last updated
Feb 24, 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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