Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
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.
1 other identifier
observational
276
2 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2021
CompletedFebruary 24, 2023
February 1, 2023
1.5 years
October 28, 2015
February 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Infant Stool Form Scale
frequency and consistency
12 weeks
Secondary Outcomes (3)
Changes from baseline to 12 weeks in Height centile
12 weeks
Changes from baseline to 12 weeks in Weight centile
12 weeks
Changes from baseline to 12 weeks in Head Circumference centile
12 weeks
Study Arms (1)
Standard Infant Formula
Standard Infant Formula containing High Sn-2
Interventions
Eligibility Criteria
500 healthy, full-term, formula fed infants
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Tadawi General Hospital
Dammam, Saudi Arabia
Almana Hospital
Jubail, Saudi Arabia
Al Mouasat Hospital
Riyadh, Saudi Arabia
Sheikh Khalifa Medical City
Abu Dhabi, United Arab Emirates
Al Garhoud Private Hospital
Dubai, United Arab Emirates
Study Officials
- PRINCIPAL INVESTIGATOR
Islam Tawfiq Al Baroudi, MD
Pediatric Gastroenterologist
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2015
First Posted
November 6, 2015
Study Start
July 1, 2018
Primary Completion
January 8, 2020
Study Completion
January 5, 2021
Last Updated
February 24, 2023
Record last verified: 2023-02