Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03390309
• Other study ID #: Fudan-AN 001
• Status: Withdrawn
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: July 2018
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 28, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Other:
• Partially Hydrolyzed Formula
Partially Hydrolyzed Whey Protein Infant Formula
• Normal Formula
Normal Formula

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).