Trial | NCT02856386  Report issue

Title

Use of a Dietary Supplement to Support Digestive Health in Children With Chronic Diarrhea
Assessment of the Utility of a Dietary Supplement as an Adjunct to Standard of Care for Children With Chronic Diarrhea

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
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 Started
Aug 31
2016
Primary Completion
Mar 31
2017
Anticipated
Study Completion
May 31
2017
Anticipated
Last Update
Aug 04
2016
Estimate

Dietary Supplement polyphenol supplement

8 mL once daily

  • Other names: Traveler Protect

polyphenol supplement Experimental

Dietary supplement administered 8 mL once daily

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
No Results Posted