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

NCT00714805 | Completed

• 1 other identifier: Internal-16637
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• GI Transit Time

  GI Transit Time is determined by measuring the levels of hydrogen gas in exhaled breath using a Hydrogen Meter.

  1 session

Study Arms (2)

ALS

Subjects having either definite or probable ALS by El Escorial Criteria.

Healthy Control

Subjects having no known ailment.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS clinic patients at MDA/ALS Center of Hope.

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

Sponsors & Collaborators

• Christine Barr: lead
• MDA/ALS Center of Hope: collaborator

Study Sites (1)

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases; Movement Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Terry D Heiman-Patterson, MD

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary contact

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: January 1, 2007
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

US (1)