Functional Gastrointestinal Disorders
Conditions
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.
Interventions
Partially Hydrolyzed Whey Protein Infant Formula
OTHERNormal Formula
Normal Formula
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 6 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Outcome results
None listed