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Non-Invasive Measurement of Gastroin...

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Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS) (GIDysmotility)

This study is currently recruiting participants.

Verified by Drexel University, July 2008 First Received: July 10, 2008 Last Updated: April 6, 2009 History of Changes Sponsor: Collaborator: Information provided by: ClinicalTrials.gov Identifier:

Drexel University College of Medicine MDA/ALS Center of Hope Drexel University NCT00714805

Purpose

Recent evidence implicates abnormalities of autonomic function in ALS including problems with gastrointestinal (GI) motility. GI complaints reported by ALS patients such as constipation, diffuse abdominal pain, and a feeling of fullness or nausea may be attributed to autonomic involvement. Toepfer et al. found delayed gastric emptying in most ALS patients, indicating autonomic dysfunction (Gastrointestinal dysfunction in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis Other Motor Neuron Disord 1999; 1:15--19). The same authors also reported markedly prolonged colon transit time in ALS (Toepfer et al: Delayed colonic transit times in amyotrophic lateral sclerosis assessed with radio-opaque markers. Eur J Med Res 1997; 2:473--476). The present study will investigate the GI transit time in a large cohort of patients and controls using a noninvasive technique that measure hydrogen gas production with the digestion of lactulose in a measured substrate load presented to the bowel.

Condition Amyotrophic Lateral Sclerosis Gastrointestinal Motility Study Type: Study Design: Observational Observational Model: Case Control Time Perspective: Cross-Sectional Non-Invasive Measurement of GI Motility in Patients With ALS

Official Title:

Resource links provided by NLM:

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Genetics Home Reference related topics: amyotrophic lateral sclerosis familial paroxysmal nonkinesigenic dyskinesia MedlinePlus related topics: Amyotrophic Lateral Sclerosis Degenerative Nerve Diseases U.S. FDA Resources

Further study details as provided by Drexel University: Estimated Enrollment: Study Start Date: Estimated Study Completion Date: Estimated Primary Completion Date: 60 January 2007 December 2009 August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts ALS Subjects having either definite or probable ALS by El Escorial Criteria. Healthy Control Subjects having no known ailment. Detailed Description: This study will examine how much time it takes for the food to travel along the intestines from mouth or stomach (if you have a feeding tube) to the end of the large intestine using a special instrument that measures hydrogen gas in your breath. Data collection will start after you sign this consent form. The only procedures that would be above and beyond routine care are indicated below: In order to prepare for the study you will be asked to be off all medications that affects the GI motility for 24 hours. You will also be asked to fast overnight (starting midnight) the day before the test. After fasting overnight, the test will be performed in the morning (at the Neurology Outpatient Clinic or at your home). Before eating or drinking anything a baseline measurement will be taken by breathing into the hydrogen meter. This will be just normal breathing. You will then drink a test meal consisting of 250 ml (approximately 1 cup) of a lactose (type of sugar) free supplement (For example Ensure) that has 20 grams of Lactulose added. If you have a peg tube then the supplement will be given through the tube. After 10 minutes you will again be asked to breath into the machine to measure the hydrogen gas levels. This will be repeated every 10 minutes until the hydrogen levels rise to a certain level or until 4 hours have passed.

Eligibility

Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: Sampling Method: Study Population ALS clinic patients at MDA/ALS Center of Hope. Criteria

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18 Years to 89 Years Both Yes Non-Probability Sample

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Inclusion Criteria: For the Disease Population: Diagnosis of definite or possible ALS by the El Escorial Criteria No previously known gastrointestinal problems Able to fast and hold medicines (anticholinergics and prokinetics) overnight prior to the measurement of GI motility No unstable medical problems and no evidence of dehydration by examination (skin turgor) For Healthy Control No known gastrointestinal illness Able to fast and hold medicines (anticholinergics) overnight prior to the measurement of GI motility No unstable medical problems or evidence of dehydration Exclusion Criteria: Patients or controls who are dehydrated Patients or controls who have evidence of previous gastrointestinal disease Patients with any unstable medical condition Patients unable to give informed consent Patients unable to blow into the breath analyzer and have steady breathing for one minute

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714805

Locations United States, Pennsylvania MDA/ALS Center of Hope Recruiting Philadelphia, Pennsylvania, United States, 19104 Contact: Christine Barr, RN 215-762-5186 [email protected] Principal Investigator: Terry Heiman-Patterson, MD Sponsors and Collaborators Drexel University College of Medicine MDA/ALS Center of Hope

More Information

No publications provided Responsible Party: ClinicalTrials.gov Identifier: Other Study ID Numbers: Study First Received: Last Updated: Health Authority: MDA/ALS Center of Hope ( Terry Heiman-Patterson, MD ) NCT00714805 History of Changes Internal-16637 July 10, 2008 April 6, 2009 United States: Institutional Review Board

Keywords provided by Drexel University: Amyotrophic Lateral Sclerosis Gastric Motility

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Autonomic Nervous System Neurodegenerative Diseases Movement Disorders Additional relevant MeSH terms: Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases

Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Pathologic Processes

ClinicalTrials.gov processed this record on August 05, 2010

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