NCT02856386

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

August 2, 2016

Last Update Submit

August 2, 2016

Conditions

Antibiotic-associated Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Time to resolution of GI symptoms

    3 weeks

Study Arms (1)

polyphenol supplement

EXPERIMENTAL

Dietary supplement administered 8 mL once daily

Dietary Supplement: polyphenol supplement

Interventions

polyphenol supplementDIETARY_SUPPLEMENT

8 mL once daily

Also known as: Traveler Protect
polyphenol supplement

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share