Status:

COMPLETED

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

Lead Sponsor:

Christine Barr

Collaborating Sponsors:

MDA/ALS Center of Hope

Conditions:

Amyotrophic Lateral Sclerosis

Eligibility:

All Genders

18-89 years

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 abdom...

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 instrume...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2016

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00714805

Start Date

January 1 2007

End Date

November 1 2016

Last Update

January 6 2017

Active Locations (1)

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MDA/ALS Center of Hope

Philadelphia, Pennsylvania, United States, 19104