Back to resultsEvaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms
Primary Purpose
Functional Gastrointestinal Disorders
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Partially Hydrolyzed Formula
Normal Formula
Sponsored by
About this trial
This is an interventional treatment trial for Functional Gastrointestinal Disorders
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
Partially Hydrolyzed Formula
Normal Formula
Arm Description
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03390309
First Posted
November 26, 2017
Last Updated
July 10, 2018
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT03390309
Brief Title
Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms
Official Title
Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
no funding
Study Start Date
July 5, 2018 (Anticipated)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
June 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Partially Hydrolyzed Formula
Arm Type
Other
Arm Description
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
Arm Title
Normal Formula
Arm Type
Placebo Comparator
Arm Description
Normal Formula
Intervention Type
Other
Intervention Name(s)
Partially Hydrolyzed Formula
Intervention Description
Partially Hydrolyzed Whey Protein Infant Formula
Intervention Type
Other
Intervention Name(s)
Normal Formula
Intervention Description
Normal Formula
Primary Outcome Measure Information:
Title
Change of total symptom score of infant feeding & stool pattern questionnaire.
Description
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms
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