Antibiotic-associated DiarrheaNCT02856386
Use of a Dietary Supplement to Support Digestive Health in Children With Chronic Diarrhea
A study testing polyphenol supplement in people with Antibiotic-associated Diarrhea, run by LiveLeaf Inc..
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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- polyphenol supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Assessment of the Utility of a Dietary Supplement as an Adjunct to Standard of Care for Children With Chronic Diarrhea
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.
Read the 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.
- Conditions
- Antibiotic-associated Diarrhea
- Being tested
- polyphenol supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyphenol supplementDietary supplement
Also called Traveler Protect
8 mL once daily
| Study group | Role | What they receive |
|---|---|---|
| polyphenol supplement | Experimental | Dietary supplement administered 8 mL once daily Receives: Dietary Supplement: polyphenol supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of GI symptoms
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LiveLeaf Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856386
- Sponsor's protocol ID
- 2016-001
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Utility of a Dietary Supplement as an Adjunct to Standard of Care for Children With Chronic Diarrhea
- ClinicalTrials.gov ID
- NCT02856386
- Acronym / sponsor ID
- 2016-001
- Conditions
- Antibiotic-associated Diarrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- LiveLeaf Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polyphenol supplement | Experimental | Dietary Supplement: polyphenol supplementDietary supplement administered 8 mL once daily |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyphenol supplementAlso: Traveler Protect8 mL once daily | Dietary supplement | polyphenol supplement |
Primary outcome
Time to resolution of GI symptoms
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing polyphenol supplement in people with Antibiotic-associated Diarrhea, run by LiveLeaf Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of GI symptoms (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.