NCT02021058

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

December 12, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2016

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

2.3 years

First QC Date

November 22, 2013

Last Update Submit

September 16, 2021

Conditions

Feeding Disorder

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline to 14 days in fuss-cry behavior

    fuss-cry behavior per 24 hours

    from baseline to 14 days

Secondary Outcomes (1)

  • Change from baseline to 14 days in GI symptoms

    from baseline to 14 days

Study Arms (2)

Experimental Formula

EXPERIMENTAL

Experimental Formula

Other: Experimental Formula

Standard Formula

OTHER

Standard Control formula

Other: Standard control formula

Interventions

Experimental FormulaOTHER

Experimental formula

Experimental Formula
Standard control formulaOTHER

Standard Infant formula

Standard Formula

Eligibility Criteria

Age30 Days - 90 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Asian Hospital and Medical Center

City of Muntinlupa, 1780, Philippines

Location

Chang Gung Memorial Hospital - Linkou

Hsiang, Taoyan Hsien, Taiwan

Location

Mackay Memorial Hospital - Tamsui

New Taipei City, Taiwan

Location

Mackay Memorial Hospital - Taipei

Taipei, Taiwan

Location

King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University

Pratumwan, Bangkok, 10330, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 33029552DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Associate Professor Boosba Vivatvakin, MD

    Pediatric Department, Faculty of Medicine, Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 27, 2013

Study Start

December 12, 2013

Primary Completion

April 1, 2016

Study Completion

August 23, 2016

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations

HK(1)TH(1)PH(1)TW(3)