Gastrointestinal DysfunctionPhase 1NCT02574611
Use of High Resolution Colonic Manometry in Studying Motility
A Phase 1 study testing Neostigmine, Glycopyrrolate and High Resolution Colonic Manometry in people with Gastrointestinal Dysfunction, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
An injury to the spinal cord (SCI) results in numerous medical complications, including gastrointestinal (GI) function. Individuals with SCI may experience severe constipation (prolonged stool retention), incontinence (accidents), and overall difficulty in bowel evacuation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Dysfunction
- What is being tested?
- Neostigmine, Glycopyrrolate and High Resolution Colonic Manometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2015to 25 Dec 2018
- Phase
- Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic SCI >1year
- Able-Bodied (non SCI)
- Undergoing Elective Colonoscopy
- Age 18-75 years.
Who cannot join
- Previous adverse reaction or hypersensitivity to electrical stimulation
- Known sensitivity to neostigmine or glycopyrrolate
- Persons with SCI who do not require additional bowel care or have "normal bowel function"
- Known hypersensitivity to neostigmine or glycopyrrolate
- History of mechanical obstruction of the intestine or urinary tract
- History of Myocardial infarction
Show all 22Show fewer
- Uncontrollable Hypertension Defined by a blood pressure reading of 160/100 mmHg or higher
- Organ damage (heart \& kidney) and/or transient ischemic attack-cerebral vascular accident as a result of hypertension
- Known past history of coronary artery disease or bradyarrythmia
- Active respiratory disease
- Known history of asthma during lifetime or recent (within 3 months) respiratory infections
- Adrenal insufficiency
- Diagnosed coagulopathy
- Any renal disease or dysfunction
- Potential for pregnancy
- Lactating/nursing females
- Slow-heart beat (HR<45 bpm)
- Lack of mental capacity to give consent
- Use of any antibiotic in the past 7 days
- Use of medications known to affect the respiratory system
- Use of medications known to alter airway caliber
- Concurrent participation in other clinical trials (within 30 days)
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: Safety and Efficacy of High Resolution Manometry in Studying Colonic Motility and Iontophoretic Administration of Prokinetic Agents
An injury to the spinal cord (SCI) results in numerous medical complications, including gastrointestinal (GI) function. Individuals with SCI may experience severe constipation (prolonged stool retention), incontinence (accidents), and overall difficulty in bowel evacuation. While various treatments and medications have been established to address this complication, there is little knowledge relating to the overall colonic motility. However, new technology such as High Resolution Colonic Manometry allows physicians to visualize high pressure contractions inside the colon, leading to a greater understanding of typical motility, a more accurate diagnosis, and an effective treatment. In this study, the investigators propose to use this technology to understand the effects of SCI on colonic motility by comparing to normal colonic function observed in able-bodied (AB) individuals. In addition, the investigators plan to study the effects of pharmacological treatments, such as neostigmine, on promoting peristaltic contractions in the colon as it is delivered across the skin.
Read the detailed description
The investigators data suggests that the fundamental consequence of SCI is a slowing of intestinal peristaltic activity, most likely as a result of down regulation of parasympathetic neural pathways. Furthermore, the investigators have effectively shown that measures involved in increase parasympathetic stimulation results in efficient bowel evacuation and improved bowel care. Such measures include the administration of neostigmine (NEO), which increases peristaltic contractions in the colon, resulting in predictable bowel evacuations. Given the cardiopulmonary side-effects of NEO, an ant-cholinergic known as Glycopyrrolate (GLY) is usually co-administered with NEO to reverse these side effects. However, the investigators knowledge regarding the effects of SCI on colonic motility is still primitive, mainly due to pervious technological disadvantages. New High Resolution Colonic Manometry systems (Medical Measurement Systems Dover, NH) simultaneously capture high amplitude pressure contractions (HAPCs) across the ascending, transverse, descending, and recto-sigmoid colon. Such capabilities allow for a much clearer display of pressure events compared to previous line tracing manometric systems and the direction of contractions are much easier to discern as well. To date, this technology has been an effective tool in diagnosing bowel disorders and complications, such as constipation in able-bodied individuals (AB). However, such studies have not been conducted in a SCI population. This technology also has the potential to capture the effects of NEO+GLY on improving colonic function.
- Conditions
- Gastrointestinal Dysfunction
- Being tested
- Neostigmine, Glycopyrrolate, Saline (Placebo), High Resolution Colonic Manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
GlycopyrrolateDrug
Saline (Placebo)Other
High Resolution Colonic ManometryDevice
| Study group | Role | What they receive |
|---|---|---|
| SCI observational | Experimental | Individuals with SCI will undergo a one day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during a "typical" day (eating, sleeping, mobility, etc.). Receives: Device: High Resolution Colonic Manometry |
| Able-bodied observational | Experimental | Able-bodied individuals (non SCI) will undergo a one day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during a "typical" day (eating, sleeping, mobility, etc.). Receives: Device: High Resolution Colonic Manometry |
| SCI drug group | Active comparator | Individuals with SCI will undergo a second day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during the transdermal administration of neostigmine and glycopyrrolate. Receives: Drug: Neostigmine; Drug: Glycopyrrolate; Device: High Resolution Colonic Manometry |
| SCI placebo group | Placebo comparator | Individuals with SCI will undergo a second day of observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during the transdermal administration of normal saline solution (placebo). Receives: Other: Saline (Placebo); Device: High Resolution Colonic Manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Amplitude Contractions
Monitor changes in High Amplitude Contractions inside the colon during a typical day for SCI and AB patients. The manometry system will record these changes and allow the investigators to visualize changes during various activities (eating, resting, supine, seated, walking, etc.) The investigators will also measure changes in contractions during administration of prokinetic agents to promote bowel evacuations
Measured: 1-2days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study start13 Oct 2015
- Primary completion25 Dec 2017
- Study completion25 Dec 2018
Why it stopped: No reportable findings are possible. The PI/Co-PI were unable to recruit participants for this study. One participant was consented but did not undergo any study procedure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dr. Mark Korsten, James J. Peters Veterans Affairs Medical Center
- Investigators
- Mark Korsten, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574611
- Sponsor's protocol ID
- KOR-15-026
- Status last verified
- Sep 2021
- First submitted
- 6 Oct 2015
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of High Resolution Manometry in Studying Colonic Motility and Iontophoretic Administration of Prokinetic Agents
- ClinicalTrials.gov ID
- NCT02574611
- Acronym / sponsor ID
- KOR-15-026
- Conditions
- Gastrointestinal Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No reportable findings are possible. The PI/Co-PI were unable to recruit participants for this study. One participant was consented but did not undergo any study procedure.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 14 Oct 2015 (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.
An injury to the spinal cord (SCI) results in numerous medical complications, including gastrointestinal (GI) function. Individuals with SCI may experience severe constipation (prolonged stool retention), incontinence (accidents), and overall difficulty in bowel evacuation. While various treatments and medications have been established to address this complication, there is little knowledge relating to the overall colonic motility. However, new technology such as High Resolution Colonic Manometry allows physicians to visualize high pressure contractions inside the colon, leading to a greater understanding of typical motility, a more accurate diagnosis, and an effective treatment. In this study, the investigators propose to use this technology to understand the effects of SCI on colonic motility by comparing to normal colonic function observed in able-bodied (AB) individuals. In addition, the investigators plan to study the effects of pharmacological treatments, such as neostigmine, on promoting peristaltic contractions in the colon as it is delivered across the skin.
Detailed description
The investigators data suggests that the fundamental consequence of SCI is a slowing of intestinal peristaltic activity, most likely as a result of down regulation of parasympathetic neural pathways. Furthermore, the investigators have effectively shown that measures involved in increase parasympathetic stimulation results in efficient bowel evacuation and improved bowel care. Such measures include the administration of neostigmine (NEO), which increases peristaltic contractions in the colon, resulting in predictable bowel evacuations. Given the cardiopulmonary side-effects of NEO, an ant-cholinergic known as Glycopyrrolate (GLY) is usually co-administered with NEO to reverse these side effects. However, the investigators knowledge regarding the effects of SCI on colonic motility is still primitive, mainly due to pervious technological disadvantages. New High Resolution Colonic Manometry systems (Medical Measurement Systems Dover, NH) simultaneously capture high amplitude pressure contractions (HAPCs) across the ascending, transverse, descending, and recto-sigmoid colon. Such capabilities allow for a much clearer display of pressure events compared to previous line tracing manometric systems and the direction of contractions are much easier to discern as well. To date, this technology has been an effective tool in diagnosing bowel disorders and complications, such as constipation in able-bodied individuals (AB). However, such studies have not been conducted in a SCI population. This technology also has the potential to capture the effects of NEO+GLY on improving colonic function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCI observational | Experimental | Device: High Resolution Colonic ManometryIndividuals with SCI will undergo a one day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during a "typical" day (eating, sleeping, mobility, etc.). |
| Able-bodied observational | Experimental | Device: High Resolution Colonic ManometryAble-bodied individuals (non SCI) will undergo a one day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during a "typical" day (eating, sleeping, mobility, etc.). |
| SCI drug group | Active comparator | Drug: Neostigmine, Drug: Glycopyrrolate, Device: High Resolution Colonic ManometryIndividuals with SCI will undergo a second day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during the transdermal administration of neostigmine and glycopyrrolate. |
| SCI placebo group | Placebo comparator | Other: Saline (Placebo), Device: High Resolution Colonic ManometryIndividuals with SCI will undergo a second day of observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during the transdermal administration of normal saline solution (placebo). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic SCI >1year
- Able-Bodied (non SCI)
- Undergoing Elective Colonoscopy
- Age 18-75 years.
Key exclusion criteria (22 listed)
- Previous adverse reaction or hypersensitivity to electrical stimulation
- Known sensitivity to neostigmine or glycopyrrolate
- Persons with SCI who do not require additional bowel care or have "normal bowel function"
- Known hypersensitivity to neostigmine or glycopyrrolate
- History of mechanical obstruction of the intestine or urinary tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neostigmine | Drug | SCI drug group |
| Glycopyrrolate | Drug | SCI drug group |
| Saline (Placebo) | Other | SCI placebo group |
| High Resolution Colonic Manometry | Device | Able-bodied observational, SCI drug group, SCI observational, SCI placebo group |
Primary outcome
High Amplitude Contractions
Time frame: 1-2days
Monitor changes in High Amplitude Contractions inside the colon during a typical day for SCI and AB patients. The manometry system will record these changes and allow the investigators to visualize changes during various activities (eating, resting, supine, seated, walking, etc.) The investigators will also measure changes in contractions during administration of prokinetic agents to promote bowel evacuations
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Mark Korsten, MD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neostigmine, Glycopyrrolate and High Resolution Colonic Manometry in people with Gastrointestinal Dysfunction, run by James J. Peters Veterans Affairs Medical Center 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 4 inclusion and 22 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: withdrawn, as of the sponsor's last update on 28 Sep 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
High Amplitude Contractions (time frame: 1-2days). 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 28 Sep 2021.