Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS)

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Christine Barr

Other

Collaborators

MDA/ALS Center of Hope

Registry information

Official study title

Non-Invasive Measurement of GI Motility in Patients With ALS

Acronym: GIDysmotility

Important dates

Study start: 2007
Primary completion: 2016
Study completion: 2016
First posted: Jul 14, 2008
Registry last updated: Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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