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

NCT ID: NCT02856386

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-05-31

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.

Conditions

Antibiotic-associated Diarrhea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

polyphenol supplement

Dietary supplement administered 8 mL once daily

Group Type: EXPERIMENTAL

polyphenol supplement

Intervention Type: DIETARY_SUPPLEMENT

8 mL once daily

Interventions

polyphenol supplement

8 mL once daily

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Traveler Protect

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LiveLeaf Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2016-001

Identifier Type: -

Identifier Source: org_study_id