Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms

July 10, 2018 updated by: Children's Hospital of Fudan University

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

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

Study Overview

Detailed Description

This study will investigate the prevalence of Shanghai area's infant with FGIDs symptom and contrast for the FGIDs symptoms by using different intervention means, and evaluate the effectiveness of FGIDs symptoms in infants by using partially hydrolyzed whey protein and low lactose infant formulation.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Partially Hydrolyzed Formula
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
Partially Hydrolyzed Whey Protein Infant Formula
Placebo Comparator: Normal Formula
Normal Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of total symptom score of infant feeding & stool pattern questionnaire.
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 5, 2018

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

June 28, 2019

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

July 12, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fudan-AN 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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