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

LiveLeaf

Status: Unknown

Conditions: Antibiotic-associated Diarrhea

Treatments: Dietary Supplement: polyphenol supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT02856386

2016-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

polyphenol supplement

Experimental group

Description:

Dietary supplement administered 8 mL once daily

Treatment:

Dietary Supplement: polyphenol supplement