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

February 22, 2023 updated by: Société des Produits Nestlé (SPN)

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Islam Tawfiq Al Baroudi, MD
  • Phone Number: +971 50 711 4814
  • Email: etwafik@skmc.ae

Study Locations

  • Saudi Arabia
      • Al Jubayl, Saudi Arabia
        • Almana Hospital
      • Dammam, Saudi Arabia
        • Tadawi General Hospital
      • Riyadh, Saudi Arabia
        • Al Mouasat Hospital
  • United Arab Emirates
      • Abou Dabi, United Arab Emirates
        • Sheikh Khalifa Medical City
      • Dubai, United Arab Emirates
        • Al Garhoud Private Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

500 healthy, full-term, formula fed infants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard Infant Formula
Standard Infant Formula containing High Sn-2
Other: Standard Infant Formula
Standard Infant Formula containing High Sn-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Stool Form Scale
Time Frame: 12 weeks
frequency and consistency
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline to 12 weeks in Height centile
Time Frame: 12 weeks
height (cm)
12 weeks
Changes from baseline to 12 weeks in Weight centile
Time Frame: 12 weeks
weight(kg) and respective Wt z-scores
12 weeks
Changes from baseline to 12 weeks in Head Circumference centile
Time Frame: 12 weeks
Head circumference (cm)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Islam Tawfiq Al Baroudi, MD, Pediatric Gastroenterologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

January 8, 2020

Study Completion (Actual)

January 5, 2021

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 15.17.INF.ME

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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