Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms

Children's Hospital of Fudan University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Functional Gastrointestinal Disorders

Interventions

Partially Hydrolyzed FormulaOTHER

Partially Hydrolyzed Whey Protein Infant Formula

Normal FormulaOTHER

Normal Formula

Eligibility

Sex: ALLMin age: 1 MonthMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

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).

Data from ClinicalTrials.gov

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