NCT03390309

Brief Summary

Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

July 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

November 26, 2017

Last Update Submit

July 10, 2018

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

  • Change of total symptom score of infant feeding & stool pattern questionnaire.

    Investigator report questionnaire. Total score consists of 6 sub scores based on different symptom scaleing : diarrhea(0= no; 1= yes), constipation(0= no; 1= yes), galactorrhea/spit milk(0= no; 1= yes), Irritability or crying(0= no; 0.5= yes), bloating/ tummy drum/ exhaust(0= no; 1= yes), other(0= no, 0.5=yes).

    From enrollment to end of treatment（1 week）. The scores will be measured at the following time point: enrollment,end of treatment(one week after the start of treatment).

Study Arms (2)

Partially Hydrolyzed Formula

OTHER

Infant was identified and got 1 or more scores by using infant feeding \& stool pattern questionnaire at Visit 1 will be assigned into experimental group randomly

Other: Partially Hydrolyzed Formula

Normal Formula

PLACEBO COMPARATOR

Normal Formula

Other: Normal Formula

Interventions

Partially Hydrolyzed FormulaOTHER

Partially Hydrolyzed Whey Protein Infant Formula

Partially Hydrolyzed Formula
Normal FormulaOTHER

Normal Formula

Normal Formula

Eligibility Criteria

Age1 Month - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants is formula-fed or mixed feeding a cow milk protein-based formula for less 7 days prior to enrollment.
  • Infant is between 30-180 days of age.
  • Infant's parent(s) or Legally authorized representative(LAR) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

You may not qualify if:

  • Complementary food was added for infants or parents are willing to add complementary food during study.
  • Suffer from infection/illness.
  • Infant has suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
  • Infant has visible bloody stools (detected before enrollment) prior to enrollment.
  • Participation in another study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2017

First Posted

January 4, 2018

Study Start

July 5, 2018

Primary Completion

December 30, 2018

Study Completion

June 28, 2019

Last Updated

July 12, 2018

Record last verified: 2018-07