Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS) (GIDysmotility)
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.
Amyotrophic Lateral Sclerosis
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Non-Invasive Measurement of GI Motility in Patients With ALS|
- GI Transit Time [ Time Frame: 1 session ] [ Designated as safety issue: No ]GI Transit Time is determined by measuring the levels of hydrogen gas in exhaled breath using a Hydrogen Meter.
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
Subjects having either definite or probable ALS by El Escorial Criteria.
Subjects having no known ailment.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714805
|Contact: Christine P Barr, RNfirstname.lastname@example.org|
|United States, Pennsylvania|
|MDA/ALS Center of Hope||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Christine Barr, RN 267-507-2585 email@example.com|
|Principal Investigator: Terry Heiman-Patterson, MD|
|Principal Investigator:||Terry D Heiman-Patterson, MD||Drexel University College of Medicine|