Gastrointestinal HemorrhagePhase 1CEPREPNCT01243736
Assessment of Combined Bowel Preparation for Capsule Endoscopy Study
A Phase 1 study testing Combination Prep in people with Gastrointestinal Hemorrhage, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators are conducting a study to see if taking a bowel preparation before having a capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the night before a capsule endoscopy in making it easier to see the small bowel in order to find the source of gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Combination Prep
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Nov 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Gastrointestinal bleeding as indication for capsule endoscopy.
- Ability to give informed consent
Who cannot join
- Subject has an allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation with PEG3350 (MoviPrep®), metoclopramide, or simethicone;
- Subjects has gastrointestinal motility disorder;
- Subjects had stomach or small bowel resection;
- Pregnancy;
- Subjects has pheochromocytoma;
- Subjects has uncontrolled hypertension;
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- Subjects has seizure disorders;
- Subjects has concurrent MAO inhibitor use;
- Subject has G6PD deficiency;
- Subjects has swallowing disorder (including impaired gag reflex);
- Subjects has hyponatremia with serum sodium less than 130 mm0l/L
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are conducting a study to see if taking a bowel preparation before having a capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the night before a capsule endoscopy in making it easier to see the small bowel in order to find the source of gastrointestinal bleeding.
Read the detailed description
This is a single-blind, prospective randomized controlled study to determine if a combination of purgative agent, prokinetic agent, simethicone, and position will improve small bowel visualization, diagnostic yield, and completion rate of capsule endoscopy.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- Combination Prep
- Keywords
- anemic, bleeding, blood in stool, abdomen pain, Gastrointestinal bleeding, capsule endoscopy (CE)
- Medical subject headings
- Gastrointestinal Hemorrhage, Hemorrhage, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination PrepDrug
Also called polyethylene glycol, simethicone, metoclopramide
combination bowel preparation, which consists of:
- drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test;
- drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test;
- drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test;
- lying on your right side for 30 minutes following the swallowing of the capsule endoscope.
| Study group | Role | What they receive |
|---|---|---|
| Standard prep | No intervention | One group will receive the standard bowel preparation, which consists of eating no solid foods after 7 p.m. the evening prior to the capsule endoscopy test and being able to consume clear liquids up to 4 hours prior to the capsule endoscopy test |
| Combination Prep | Active comparator | The other group will receive the combination bowel preparation, which consists of taking the standard bowel preparation plus:
1. drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test;
2. drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test;
3. drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test;
4. lying on your right side for 30 minutes following the swallowing of the capsule endoscope. Receives: Drug: Combination Prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy
The primary endpoints of small bowel visualization quality, diagnostic yield, and completion rate will be compared between groups using Pearson's chi-square test.
Measured: 1 year
Secondary outcomes (2)
Safety outcomes and Patient satisfaction
secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test.
Measured: 1 year
gastric transit time
A group comparison for the secondary outcome of gastric transit time will be done using a two-sample t-test or Wilcoxon rank-sum test, as appropriate.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie L. Hansel, Mayo Clinic
- Investigators
- Stephanie L. Hansel, M.D., Principal investigator, Mayo ClinicElizabeth Rajan, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243736
- Sponsor's protocol ID
- 10-000198
- Acronym
- CEPREP
- Status last verified
- Jan 2016
- First submitted
- 19 Oct 2010
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansel SL, Murray JA, Alexander JA, Bruining DH, Larson MV, Mangan TF, Dierkhising RA, Almazar AE, Rajan E. Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized-controlled study. Gastroenterol Rep (Oxf). 2019 Oct 19;8(1):31-35. doi: 10.1093/gastro/goz054. eCollection 2020 Feb.
PubMed 32419949
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Combined Bowel Preparation for Capsule Endoscopy Study
- ClinicalTrials.gov ID
- NCT01243736
- Acronym / sponsor ID
- CEPREP / 10-000198
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- anemic, bleeding, blood in stool, abdomen pain, Gastrointestinal bleeding, capsule endoscopy (CE)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Nov 2010 (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.
The investigators are conducting a study to see if taking a bowel preparation before having a capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the night before a capsule endoscopy in making it easier to see the small bowel in order to find the source of gastrointestinal bleeding.
Detailed description
This is a single-blind, prospective randomized controlled study to determine if a combination of purgative agent, prokinetic agent, simethicone, and position will improve small bowel visualization, diagnostic yield, and completion rate of capsule endoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard prep | No intervention | –One group will receive the standard bowel preparation, which consists of eating no solid foods after 7 p.m. the evening prior to the capsule endoscopy test and being able to consume clear liquids up to 4 hours prior to the capsule endoscopy test |
| Combination Prep | Active comparator | Drug: Combination PrepThe other group will receive the combination bowel preparation, which consists of taking the standard bowel preparation plus: 1. drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test; 2. drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test; 3. drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test; 4. lying on your right side for 30 minutes following the swallowing of the capsule endoscope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old
- Gastrointestinal bleeding as indication for capsule endoscopy.
- Ability to give informed consent
Key exclusion criteria (11 listed)
- Subject has an allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation with PEG3350 (MoviPrep®), metoclopramide, or simethicone;
- Subjects has gastrointestinal motility disorder;
- Subjects had stomach or small bowel resection;
- Pregnancy;
- Subjects has pheochromocytoma;
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 |
|---|---|---|
| Combination PrepAlso: polyethylene glycol, simethicone, metoclopramidecombination bowel preparation, which consists of: 1. drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test; 2. drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test; 3. drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test; 4. lying on your right side for 30 minutes following the swallowing of the capsule endoscope. | Drug | Combination Prep |
Primary outcome
Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy
Time frame: 1 year
The primary endpoints of small bowel visualization quality, diagnostic yield, and completion rate will be compared between groups using Pearson's chi-square test.
2 secondary outcomes
Safety outcomes and Patient satisfaction
Time frame: 1 year
gastric transit time
Time frame: 1 year
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 20 Jan 2016.
- Derived from this study: PubMed 32419949Hansel SL, Murray JA, Alexander JA, Bruining DH, Larson MV, Mangan TF, Dierkhising RA, Almazar AE, Rajan E. Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized-controlled study. Gastroenterol Rep (Oxf). 2019 Oct 19;8(1):31-35. doi: 10.1093/gastro/goz054. eCollection 2020 Feb.
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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.
Stephanie L. Hansel, M.D. principal investigator
Mayo Clinic
Elizabeth Rajan, M.D. principal investigator
Mayo Clinic
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 Combination Prep in people with Gastrointestinal Hemorrhage, run by Mayo Clinic 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 3 inclusion and 11 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 20 Jan 2016. 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.
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 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?
Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01243736, which also lists 1 linked publication.
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 20 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.