Amyotrophic Lateral SclerosisGIDysmotilityNCT00714805
Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS)
An observational study of Amyotrophic Lateral Sclerosis, run by Christine Barr at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ALS clinic patients at MDA/ALS Center of Hope.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
MDA/ALS Center of Hope
Philadelphia, Pennsylvania, 19104
About this study
Official title: Non-Invasive Measurement of GI Motility in Patients With ALS
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Gastric Motility, Autonomic Nervous System, Neurodegenerative Diseases, Movement Disorders, Gastrointestinal Motility
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Neurodegenerative Diseases, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALS | Subjects having either definite or probable ALS by El Escorial Criteria. | |
| Healthy Control | Subjects having no known ailment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI Transit Time
GI Transit Time is determined by measuring the levels of hydrogen gas in exhaled breath using a Hydrogen Meter.
Measured: 1 session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJan 2007
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christine Barr
- Sponsor type
- University, hospital or other
- Collaborators
- MDA/ALS Center of Hope
- Responsible party
- Sponsor-investigator, Christine Barr, Drexel University
- Investigators
- Terry D Heiman-Patterson, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714805
- Sponsor's protocol ID
- Internal-16637
- Acronym
- GIDysmotility
- Status last verified
- Jan 2017
- First submitted
- 10 Jul 2008
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Measurement of GI Motility in Patients With ALS
- ClinicalTrials.gov ID
- NCT00714805
- Acronym / sponsor ID
- GIDysmotility / Internal-16637
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Gastric Motility, Autonomic Nervous System, Neurodegenerative Diseases, Movement Disorders, Gastrointestinal Motility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Christine BarrUniversity, hospital or other
- Collaborators
- MDA/ALS Center of Hope
- Study start
- Jan 2007
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS | – | –Subjects having either definite or probable ALS by El Escorial Criteria. |
| Healthy Control | – | –Subjects having no known ailment. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ALS clinic patients at MDA/ALS Center of Hope.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry D Heiman-Patterson, MD principal investigator
Drexel University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Christine Barr at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI Transit Time (time frame: 1 session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.