Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms

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

Detailed Description
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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.

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

Conditions
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Functional Gastrointestinal Disorders

Intervention / Treatment
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* Other: Partially Hydrolyzed Formula
* Other: Normal Formula


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Partially Hydrolyzed Formula<br>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<br>* Partially Hydrolyzed Whey Protein Infant Formula<br>|
| Placebo Comparator: Normal Formula<br>Normal Formula | Other: Normal Formula<br>* Normal Formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |