Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Christine Barr
With
MDA/ALS Center of Hope
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.
Age
18–89
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS)