Back to resultsUse of a Dietary Supplement to Support Digestive Health in Children With Chronic Diarrhea
Primary Purpose
Antibiotic-associated Diarrhea
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polyphenol supplement
Sponsored by
About this trial
This is an interventional supportive care trial for Antibiotic-associated Diarrhea
Eligibility Criteria
Inclusion Criteria:
- Out-patients with diagnosis of unresolved gastrointestinal distress
- Parent or guardian willing to administer the dietary supplement orally once daily for up to 21 days
- Parent or guardian willing to record changes in GI symptoms on a questionnaire
- Parent or guardian willing to bring the child for a clinic visit to close-out participation in the study
Exclusion Criteria:
- requires care in an ICU
- has documented intestinal stricture, stenosis, obstruction, or abscess
- has concomitant congenital diseases
- are immunodeficient
- has malformation of the GI tract
- is unable to swallow fluids
- parent or guardian is unable or unwilling to provide informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
polyphenol supplement
Arm Description
Dietary supplement administered 8 mL once daily
Outcomes
Primary Outcome Measures
Time to resolution of GI symptoms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02856386
Brief Title
Use of a Dietary Supplement to Support Digestive Health in Children With Chronic Diarrhea
Official Title
Assessment of the Utility of a Dietary Supplement as an Adjunct to Standard of Care for Children With Chronic Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LiveLeaf Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Micronutrients missing in the diet may assist in supporting digestive health in children with chronic GI issues. This study will monitor changes in symptoms associated with digestive problems in children provided with a dietary supplement that will be taken in conjunction with the standard of care.
Detailed Description
Children with GI symptoms have varying response to the standard of care treatments. A dietary supplement of polyphenols from green tea and pomegranate extracts provides micronutrients often missing from conventional American diets. The objective of this study is to monitor changes in GI symptoms when the supplement is provided alongside the standard of care for children with symptoms that have been present for more than two weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-associated Diarrhea
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
polyphenol supplement
Arm Type
Experimental
Arm Description
Dietary supplement administered 8 mL once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
polyphenol supplement
Other Intervention Name(s)
Traveler Protect
Intervention Description
8 mL once daily
Primary Outcome Measure Information:
Title
Time to resolution of GI symptoms
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Out-patients with diagnosis of unresolved gastrointestinal distress
Parent or guardian willing to administer the dietary supplement orally once daily for up to 21 days
Parent or guardian willing to record changes in GI symptoms on a questionnaire
Parent or guardian willing to bring the child for a clinic visit to close-out participation in the study
Exclusion Criteria:
requires care in an ICU
has documented intestinal stricture, stenosis, obstruction, or abscess
has concomitant congenital diseases
are immunodeficient
has malformation of the GI tract
is unable to swallow fluids
parent or guardian is unable or unwilling to provide informed consent
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of a Dietary Supplement to Support Digestive Health in Children With Chronic Diarrhea
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