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Study in Unsettled Infants Experiencing Feeding Intolerance

Primary Purpose

Feeding Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Experimental Formula
Standard control formula
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding Disorder

Eligibility Criteria

30 Days - 90 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Full term infants, singleton, healthy at birth
  2. Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
  3. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
  4. 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:

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

Sites / Locations

  • The Chinese University of Hong Kong
  • Asian Hospital and Medical Center
  • Chang Gung Memorial Hospital - Linkou
  • Mackay Memorial Hospital - Tamsui
  • Mackay Memorial Hospital - Taipei
  • King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Formula

Standard Formula

Arm Description

Experimental Formula

Standard Control formula

Outcomes

Primary Outcome Measures

Changes from baseline to 14 days in fuss-cry behavior
fuss-cry behavior per 24 hours

Secondary Outcome Measures

Change from baseline to 14 days in GI symptoms

Full Information

First Posted
November 22, 2013
Last Updated
September 16, 2021
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02021058
Brief Title
Study in Unsettled Infants Experiencing Feeding Intolerance
Official Title
Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2013 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
August 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Formula
Arm Type
Experimental
Arm Description
Experimental Formula
Arm Title
Standard Formula
Arm Type
Other
Arm Description
Standard Control formula
Intervention Type
Other
Intervention Name(s)
Experimental Formula
Intervention Description
Experimental formula
Intervention Type
Other
Intervention Name(s)
Standard control formula
Intervention Description
Standard Infant formula
Primary Outcome Measure Information:
Title
Changes from baseline to 14 days in fuss-cry behavior
Description
fuss-cry behavior per 24 hours
Time Frame
from baseline to 14 days
Secondary Outcome Measure Information:
Title
Change from baseline to 14 days in GI symptoms
Time Frame
from baseline to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Associate Professor Boosba Vivatvakin, MD
Organizational Affiliation
Pediatric Department, Faculty of Medicine, Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Asian Hospital and Medical Center
City
Muntinlupa
ZIP/Postal Code
1780
Country
Philippines
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Hsiang, Taoyan Hsien
Country
Taiwan
Facility Name
Mackay Memorial Hospital - Tamsui
City
New Taipei City
Country
Taiwan
Facility Name
Mackay Memorial Hospital - Taipei
City
Taipei City
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University
City
Pratumwan, Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33029552
Citation
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.
Results Reference
derived

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Study in Unsettled Infants Experiencing Feeding Intolerance

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