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

Antibiotic-associated Diarrhea Clinical Trial

Official title:

Assessment of the Utility of a Dietary Supplement as an Adjunct to Standard of Care for Children With Chronic Diarrhea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02856386
• Other study ID #: 2016-001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 2, 2016
• Start date: August 2016
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: LiveLeaf Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 17 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Antibiotic-associated Diarrhea
• Diarrhea

Intervention

Dietary Supplement:
• polyphenol supplement
8 mL once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LiveLeaf Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to resolution of GI symptoms		3 weeks	No