- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03390309
Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms
July 10, 2018 updated by: Children's Hospital of Fudan University
Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 6 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Partially Hydrolyzed Formula
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
|
Partially Hydrolyzed Whey Protein Infant Formula
|
Placebo Comparator: Normal Formula
|
Normal Formula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of total symptom score of infant feeding & stool pattern questionnaire.
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).
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 5, 2018
Primary Completion (Anticipated)
December 30, 2018
Study Completion (Anticipated)
June 28, 2019
Study Registration Dates
First Submitted
November 26, 2017
First Submitted That Met QC Criteria
January 3, 2018
First Posted (Actual)
January 4, 2018
Study Record Updates
Last Update Posted (Actual)
July 12, 2018
Last Update Submitted That Met QC Criteria
July 10, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fudan-AN 001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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