Study in Unsettled Infants Experiencing Feeding Intolerance | NCT02021058

Studies
Study in Unsettled Infants Experiencing Feeding Intolerance

NCT02021058

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Sep 17, 2021Actual

Enrollment

259Actual

Phase

Not Applicable

Conditions

Feeding Disorder

Interventions

Experimental Formula
Standard control formula

Countries

Hong Kong
Philippines
Taiwan
Thailand

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

Sep 2021

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

Dec 12, 2013Actual

Primary Completion Date

Apr 2016Actual

Completion Date

Aug 23, 2016Actual

First Submitted Date

Nov 22, 2013

First Submission Date that Met QC Criteria

Dec 19, 2013

First Posted Date

Dec 27, 2013Estimated

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

Sep 16, 2021

Last Update Posted Date

Sep 17, 2021Actual

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

Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance

Detailed Description

The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

259Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Formula	Experimental	Experimental Formula	Other: Experimental Formula
Standard Formula	Other	Standard Control formula	Other: Standard control formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental Formula	Other	Experimental formula	Experimental Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes from baseline to 14 days in fuss-cry behavior	fuss-cry behavior per 24 hours	from baseline to 14 days

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline to 14 days in GI symptoms		from baseline to 14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Full term infants, singleton, healthy at birth
Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.

Exclusion Criteria:

Infants who are consuming any amount of supplemental human milk
Infants who are consuming weaning foods or beverages other than infant formula
Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
Infants who have a medical condition or history that could cause or contribute to feeding intolerance
Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Days

Maximum Age

90 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Associate Professor Boosba Vivatvakin, MD	Pediatric Department, Faculty of Medicine, Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese University of Hong Kong		Shatin, New Territories			Hong Kong
Asian Hospital and Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33029552	Derived	Vivatvakin B, Estorninos E, Lien R, Lee HC, Hon KLE, Lebumfacil J, Cercamondi CI, Volger S. Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial. Glob Pediatr Health. 2020 Sep 25;7:2333794X20954332. doi: 10.1177/2333794X20954332. eCollection 2020.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders