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

Sponsor:	Drexel University College of Medicine
Collaborator:	MDA/ALS Center of Hope
Information provided by:	Drexel University
ClinicalTrials.gov Identifier:	NCT00714805

Purpose

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
Amyotrophic Lateral Sclerosis Gastrointestinal Motility

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	Non-Invasive Measurement of GI Motility in Patients With ALS

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Degenerative Nerve Diseases

U.S. FDA Resources

Further study details as provided by Drexel University:

Estimated Enrollment:	60
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
ALS Subjects having either definite or probable ALS by El Escorial Criteria.
Healthy Control Subjects having no known ailment.

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.

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

ALS clinic patients at MDA/ALS Center of Hope.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714805

Locations

United States, Pennsylvania
MDA/ALS Center of Hope	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christine Barr, RN 267-507-2585 cbarr@drexelmed.edu
Principal Investigator: Terry Heiman-Patterson, MD

Sponsors and Collaborators

Drexel University College of Medicine

MDA/ALS Center of Hope

More Information

No publications provided

Responsible Party:	Terry Heiman-Patterson, MD, MDA/ALS Center of Hope
ClinicalTrials.gov Identifier:	NCT00714805 History of Changes
Other Study ID Numbers:	Internal-16637
Study First Received:	July 10, 2008
Last Updated:	March 24, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Drexel University:

Amyotrophic Lateral Sclerosis
Gastric Motility
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases

Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012