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

• ClinicalTrials.gov Identifier: NCT00714805
• Recruitment Status: Completed
• First Posted: July 14, 2008
• Last Update Posted: January 6, 2017
• Sponsor: Christine Barr
• Collaborator: 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
• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 5, 2017): 41
• Original Estimated Enrollment (submitted: July 10, 2008): 60
• 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

Sex/Gender

• 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

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

Investigators

• Principal Investigator: Terry D Heiman-Patterson, MD; Drexel University College of Medicine

• PRS Account: Drexel University
• Verification Date: January 2017