Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Observational

Summary: 
      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.
    

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.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ALS clinic patients at MDA/ALS Center of Hope.
      
Keywords: Amyotrophic Lateral Sclerosis; Gastric Motility; Autonomic Nervous System; Neurodegenerative Diseases; Movement Disorders; Gastrointestinal Motility