We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00714805
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : January 6, 2017
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Christine Barr, Drexel University

Tracking Information
First Submitted Date July 10, 2008
First Posted Date July 14, 2008
Last Update Posted Date January 6, 2017
Study Start Date January 2007
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2013)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official Title Non-Invasive Measurement of GI Motility in Patients With ALS
Brief 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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ALS clinic patients at MDA/ALS Center of Hope.
Condition Amyotrophic Lateral Sclerosis
Intervention Not Provided
Study Groups/Cohorts
  • ALS
    Subjects having either definite or probable ALS by El Escorial Criteria.
  • Healthy Control
    Subjects having no known ailment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 5, 2017)
Original Estimated Enrollment
 (submitted: July 10, 2008)
Actual Study Completion Date November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00714805
Other Study ID Numbers Internal-16637
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Christine Barr, Drexel University
Original Responsible Party Terry Heiman-Patterson, MD, MDA/ALS Center of Hope
Current Study Sponsor Christine Barr
Original Study Sponsor Drexel University
Collaborators MDA/ALS Center of Hope
Principal Investigator: Terry D Heiman-Patterson, MD Drexel University College of Medicine
PRS Account Drexel University
Verification Date January 2017