Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS) (GIDysmotility)
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|ClinicalTrials.gov Identifier: NCT00714805|
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : January 6, 2017
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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 or disease|
|Amyotrophic Lateral Sclerosis|
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.
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Official Title:||Non-Invasive Measurement of GI Motility in Patients With ALS|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Subjects having either definite or probable ALS by El Escorial Criteria.
Subjects having no known ailment.
- GI Transit Time [ Time Frame: 1 session ]GI Transit Time is determined by measuring the levels of hydrogen gas in exhaled breath using a Hydrogen Meter.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 89 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714805
|United States, Pennsylvania|
|MDA/ALS Center of Hope|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Terry D Heiman-Patterson, MD||Drexel University College of Medicine|
|Responsible Party:||Christine Barr, Primary contact, Drexel University|
|Other Study ID Numbers:||
|First Posted:||July 14, 2008 Key Record Dates|
|Last Update Posted:||January 6, 2017|
|Last Verified:||January 2017|
Amyotrophic Lateral Sclerosis
Autonomic Nervous System
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases