Antibiotic-associated Diarrhea
Conditions
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.
Interventions
DIETARY_SUPPLEMENTpolyphenol supplement
8 mL once daily
Sponsors
LiveLeaf Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to resolution of GI symptoms | 3 weeks |
Outcome results
None listed