Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)

NCT01248221 | Completed Results

• 3 other identifiers: 09-006643P01DK068055UL1RR024150
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia. Subjects will eat a standard meal of 2 scrambled eggs, a slice of wheat toast and 8 ounces of skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and 13C-Spirulina platensis. Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body tissue is produced through the detection of radiation emitted by a radioactive substance administered into the body. The location of a standard meal in the digestive system will be measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical diagnostic procedures. Spirulina platensis is blue - green algae, which is very similar to the naturally occurring spirulina sold in health food stores as a dietary supplement. The spirulina platensis has been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as 1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will be measured by breath samples at periodic intervals before and after a standard meal. The FDA considers 13C-Spirulina platensis to be investigational for the purposes of this study.

Conditions

Dyspepsia

Keywords

Breath test; Dyspepsia; Gastric Emptying; Gastroparesis

Outcome Measures

Primary Outcomes (2)

• Gastric Emptying Half Time Measured by Scintigraphy

  Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by standard 99m Tc scintigraphy.

  4 hours after ingestion of standard meal

• Gastric Emptying Half Time Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)

  Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.

  4 hours after ingestion of standard meal

Secondary Outcomes (2)

• Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy

  60, 120, and 240 minutes after ingestion of standard meal

• Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)

  60, 120, and 240 minutes after ingestion of standard meal

Study Arms (2)

Healthy subjects

EXPERIMENTAL

The subject will consume the test meal containing \[13C\]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.

Drug: [13C]-Spirulina platensis and 99mTc sulfur colloid

Dyspeptic subjects

EXPERIMENTAL

The subject will consume the test meal containing \[13C\]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.

Drug: [13C]-Spirulina platensis and 99mTc sulfur colloid

Interventions

[13C]-Spirulina platensis and 99mTc sulfur colloid DRUG

The subject will consume the test meal containing 13C-Spirulina and 99mTc sulfur colloid in no more than 10 minutes. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.

Dyspeptic subjects; Healthy subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or non-pregnant, non-breastfeeding female volunteers
• years of age
• Able to provide written informed consent before participating in the study
• Able to communicate adequately with the Investigator and to comply with the requirements of for the entire study, i.e., able to eat test meal and provide breath samples.
• One or more of eight postprandial dyspeptic symptoms i.e., fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, OR
• Patients fulfilling the ROME-III criteria for functional dyspepsia,
• AND no symptom improvement under a standard dose proton-pump inhibitor (PPI) treatment,
• AND an upper gastrointestinal endoscopy negative for significant pathology that would explain symptoms done within the last 5 years prior to the study.

You may not qualify if:

• Severe nausea or vomiting precluding study assessments
• Use of medications that alter GI motility e.g., narcotics or medications with significant anticholinergic effects within two days of the study
• History of malabsorption due to mucosal disease, pancreatic disease, liver dysfunction, or other causes
• Abdominal surgery other than appendectomy, cholecystectomy, tubal ligation or hysterectomy
• Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that may interfere with the objectives of the study
• Patients who are allergic to eggs, wheat, or milk, or unwilling to consume these products
• Patients who have taken any investigational medications within the past 30 days.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Center for Research Resources (NCRR): collaborator
• Advanced Breath Diagnostics, LLC: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Dyspepsia; Gastroparesis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations

Results Point of Contact

• Title: Dr. Adil E. Bharucha
• Organization: Mayo Clinic

bharucha.adil@mayo.edu

507-284-2687

Study Officials

• Adil E Bharucha, MBBS, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 25, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 18, 2013
• Results First Posted: March 18, 2013

Record last verified: 2013-02

Locations

US (1)