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Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Normal Formula | Placebo Comparator | Normal Formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partially Hydrolyzed Formula | Other | Partially Hydrolyzed Whey Protein Infant Formula |
|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Normal Formula | Other | Normal Formula |
|