Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS)
Completed
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00714805
- Run by
- Christine Barr
- People needed
- 41
- Starts
- 2007-01-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2017-01-06
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.
You may qualify 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 qualify 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
Where it is running
- MDA/ALS Center of Hope — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.