Acceptability and Gastrointestinal Tolerance of a High-Sn... | NCT02598817

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

NCT02598817

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Feb 24, 2023Actual

Enrollment

276Actual

Phase

Not provided

Conditions

Infant Term Birth

Interventions

Standard Infant Formula

Countries

Saudi Arabia
United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jan 8, 2020Actual

Completion Date

Jan 5, 2021Actual

First Submitted Date

Oct 28, 2015

First Submission Date that Met QC Criteria

Nov 4, 2015

First Posted Date

Nov 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2023

Last Update Posted Date

Feb 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

276Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Infant Formula		Standard Infant Formula containing High Sn-2	Other: Standard Infant Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Infant Formula	Other	Standard Infant Formula containing High Sn-2	Standard Infant Formula

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

12 Weeks

Standard Ages

Child

Study Population

500 healthy, full-term, formula fed infants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Islam Tawfiq Al Baroudi, MD	Pediatric Gastroenterologist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tadawi General Hospital		Dammam			Saudi Arabia
Almana Hospital