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Procedure

GEBT Reference Range for Pediatric Gastroparesis

N/A

Recruiting

Led By Catherine E Williams, PhD

Research Sponsored by Cairn Diagnostics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children ages 7 to 18 years who provide written assent and whose parents provide written consent for participation

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 to 240 minutes

Awards & highlights

Study Summary

This trial aims to understand the normal rate of stomach emptying in children, to aid in diagnosis of gastroparesis.

Who is the study for?

This trial is for healthy children aged 7 to 18 with no significant medical history or developmental delays. They must be able to eat a special test meal and provide breath samples. Children with gastrointestinal, pancreatic, liver diseases, severe respiratory conditions, diabetes, chronic GI symptoms, mental retardation or on drugs affecting stomach function can't participate.Check my eligibility

What is being tested?

The trial tests the normal response in kids to the GEBT for diagnosing gastroparesis. It involves eating a Spirulina-enhanced meal and measuring how fast food leaves the stomach by analyzing carbon-13 in their breath before and after eating.See study design

What are the potential side effects?

Since this test involves only eating a meal containing Spirulina and providing breath samples, there are minimal expected side effects. However, participants allergic to ingredients like egg or gluten cannot take part due to potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 7 to 18 years old and both my parents and I agree to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 to 240 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 to 240 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 to 240 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Test meal/test completion

Tmax (mins)

kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Reference Range determinationExperimental Treatment1 Intervention

13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants

Group II: Biological VariabilityActive Control1 Intervention

13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cairn DiagnosticsLead Sponsor

4 Previous Clinical Trials

164 Total Patients Enrolled

4 Trials studying Gastroparesis

164 Patients Enrolled for Gastroparesis

Baylor College of MedicineOTHER

1,001 Previous Clinical Trials

6,002,112 Total Patients Enrolled

4 Trials studying Gastroparesis

736 Patients Enrolled for Gastroparesis

Medical College of WisconsinOTHER

610 Previous Clinical Trials

1,162,413 Total Patients Enrolled

1 Trials studying Gastroparesis

216 Patients Enrolled for Gastroparesis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial welcoming participants who are above the age of thirty?

"The necessary requirements for the trial dictate that potential enrollees must be aged between 7 and 18."

Answered by AI

Is this experiment presently searching for participants?

"Affirmative. According to details listed on clinicaltrials.gov, this experiment is currently seeking participants and has been doing so since March 17th 2023. The most recent edit was made on August 21st 2023 with the goal of finding 300 patients at two distinct locations."

Answered by AI

Are there any eligibility criteria for participating in this investigation?

"This medical study requires that applicants have gastroparesis and are between 7-18 years old. Approximately 300 participants must be recruited in order for the trial to move forward."

Answered by AI

How many individuals are currently enrolled in this research endeavor?

"Affirmative. Per the records hosted on clinicaltrials.gov, this trial was initially advertised on March 17th 2023 and is currently recruiting participants for its study of 300 patients across 2 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)

2023. "Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06004596.

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