Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms

Not Applicable

Withdrawn

• Conditions: Functional Gastrointestinal Disorders
• Interventions: Other: Normal Formula; Other: Partially Hydrolyzed Formula

• Registration Number: NCT03390309
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-11-26
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-04
• Status Verified: 2018-07
• Study Start: 2018-07-05
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-12
• Primary Completion: 2018-12-30
• Study Completion: 2019-06-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Formula	Normal Formula	Normal Formula
Partially Hydrolyzed Formula	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

Primary Outcome Measures

Name	Time	Method
Change of total symptom score of infant feeding & stool pattern questionnaire.	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).