Use of a Dietary Supplement to Support Digestive Health in Children With Chronic Diarrhea

Not Applicable

• Conditions: Antibiotic-associated Diarrhea
• Interventions: Dietary Supplement: polyphenol supplement

• Registration Number: NCT02856386
• Lead Sponsor: LiveLeaf Inc.

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.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Last Update Submitted: 2016-08-02
• Study First Posted: 2016-08-04
• Last Update Posted: 2016-08-04
• Primary Completion: 2017-03
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
polyphenol supplement	polyphenol supplement	Dietary supplement administered 8 mL once daily

Primary Outcome Measures

Name	Time	Method
Time to resolution of GI symptoms	3 weeks