Study in Unsettled Infants Experiencing Feeding Intolerance

Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance

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

Study Overview

• Status: Completed
• Conditions: Feeding Disorder
• Intervention / Treatment: Other: Experimental Formula; Other: Standard control formula

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.

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, New Territories, Hong Kong
    • The Chinese University of Hong Kong
• Philippines
  • Muntinlupa, Philippines, 1780
    • Asian Hospital and Medical Center
• Taiwan
  • Hsiang, Taoyan Hsien, Taiwan
    • Chang Gung Memorial Hospital - Linkou
  • New Taipei City, Taiwan
    • Mackay Memorial Hospital - Tamsui
  • Taipei City, Taiwan
    • Mackay Memorial Hospital - Taipei
• Thailand
  • Pratumwan, Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Formula	Other: Experimental Formula; Experimental formula
Other: Standard Formula; Standard Control formula	Other: Standard control formula; Standard Infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Associate Professor Boosba Vivatvakin, MD, Pediatric Department, Faculty of Medicine, Chulalongkorn University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): August 23, 2016

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 13.10.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No