ColonoscopyNCT00675324
Bowel Preparation Before Colonoscopy
A study testing Laxabon and Fresubin Energy drink in people with Colonoscopy and Bowel Preparation, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Bowel preparation can be a troublesome procedure for patients undergoing colonoscopy. For patients with cardio-vascular and kidney disorders it may be dangerous with traditional bowel preparation with regard to salt and electrolyte balance. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- Laxabon and Fresubin Energy drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2008to Oct 2009
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men
- women
- age 18-90 years
Who cannot join
- patients under 18 years
- acute colitis
- acute ileus
- seriously dementia
- patients from other counties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation
Bowel preparation can be a troublesome procedure for patients undergoing colonoscopy. For patients with cardio-vascular and kidney disorders it may be dangerous with traditional bowel preparation with regard to salt and electrolyte balance. This study's purpose is to find out if nutritional drinks can replace traditional bowel preparation before colonoscopy in regard to Bowel purity degree, disturbances in the salt and electrolyte balance in the nutritional group versus the group that gets traditional bowel preparation. And if the patients tolerate nutritional drinks better than traditional bowel preparation.
Read the detailed description
Today colonoscopy is a standard method for examination of the colon. To correctly diagnose and give adequate therapy after colonoscopy examination it is necessary with a thoroughly done bowel preparation, i.e. the intestines should preferably be empty. The ideal preparation should not only be reliable and easy to carry out but also be done without discomfort for the patient. Unfortunately we do not today have any purgative that fulfils these criteria's.
Studies have shown that Phosforal compared to Laxabon have the same or even a better effect regarding the bowel preparation and also a higher patient tolerance. The amount of side effects with Phosforal is larger and has potentially greater medical effects for the patient. Phosforal might result in serious changes in the liquid- and salt-balance and especially patients with heart diseases and kidney dysfunctions should be restricted to use this preparation.
Laxabon, on the other hand, has not showed any side effects for changes in the salt balance, but studies have shown that up to 40% of the patients are not able to drink such a large amount as four litres. Side effects as nausea, vomiting and discomfort are common.
At Ersta hospital we have for many years done research studies on the metabolic response in connection with surgery. Patients undergoing surgery for cancer in the rectum often are prepared with energy drinks in order to receive a higher energy level before the operation. As a result of this the patients often avoid nausea and have a better intestinal function after surgery. We think that this treatment has worked well on the patients but no scientific studies have been done on these patients. As a complementary result of the treatment with nutritional drinks we have found that the colon is empty already after a short time of treatment. We have also prepared some patient for colonoscopy, that due to their primary disease not are able to use traditional purgatives, with nutritional drinks for five days combined with a local purgative on the day of the examination. The colonoscopy examination on these patients were performed without any problems. We have found no studies describing this preparation before colonoscopy.
This is a study that will find out if traditional preparation before colonoscopy could be replaced by nutritional drinks combined with local purgative on the day of the examination.
- Conditions
- Colonoscopy, Bowel Preparation
- Being tested
- Laxabon, Fresubin Energy drink
- Keywords
- Colonoscopy, Bowel preparation, Salt and electrolyte balance, Patients undergoing colonoscopy, Complication with traditional bowel preparation, Bowel purity degree without traditional bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaxabonDrug
Laxabon 4 litres, starting the day (e.m.) before the colonoscopy
Fresubin Energy drinkDietary supplement
30 kcal/kg*day five days before colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Traditional bowel preparation with Laxabon Receives: Drug: Laxabon |
| B | Active comparator | Bowel preparation with nutritional drinks Receives: Dietary Supplement: Fresubin Energy drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel purity degree
Measured: day of coclonscopy
Secondary outcomes (1)
Reduction of complications for patients with cardio- vascular and kidney diseases
Measured: day of cocloscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: The bowel was not clean when the colonoscopy was performed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Research department, Ersta Hospital
- Responsible party
- Principal investigator, Ulf Gustafsson, Karolinska Institutet
- Investigators
- Ulf Gustafsson, PhD, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675324
- Sponsor's protocol ID
- 2008/104-31/3
- Status last verified
- Sep 2012
- First submitted
- 7 May 2008
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation
- ClinicalTrials.gov ID
- NCT00675324
- Acronym / sponsor ID
- 2008/104-31/3
- Conditions
- Colonoscopy, Bowel Preparation
- Keywords
- Colonoscopy, Bowel preparation, Salt and electrolyte balance, Patients undergoing colonoscopy, Complication with traditional bowel preparation, Bowel purity degree without traditional bowel preparation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The bowel was not clean when the colonoscopy was performed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Research department, Ersta Hospital
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 May 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.
Bowel preparation can be a troublesome procedure for patients undergoing colonoscopy. For patients with cardio-vascular and kidney disorders it may be dangerous with traditional bowel preparation with regard to salt and electrolyte balance. This study's purpose is to find out if nutritional drinks can replace traditional bowel preparation before colonoscopy in regard to Bowel purity degree, disturbances in the salt and electrolyte balance in the nutritional group versus the group that gets traditional bowel preparation. And if the patients tolerate nutritional drinks better than traditional bowel preparation.
Detailed description
Today colonoscopy is a standard method for examination of the colon. To correctly diagnose and give adequate therapy after colonoscopy examination it is necessary with a thoroughly done bowel preparation, i.e. the intestines should preferably be empty. The ideal preparation should not only be reliable and easy to carry out but also be done without discomfort for the patient. Unfortunately we do not today have any purgative that fulfils these criteria's.
Studies have shown that Phosforal compared to Laxabon have the same or even a better effect regarding the bowel preparation and also a higher patient tolerance. The amount of side effects with Phosforal is larger and has potentially greater medical effects for the patient. Phosforal might result in serious changes in the liquid- and salt-balance and especially patients with heart diseases and kidney dysfunctions should be restricted to use this preparation.
Laxabon, on the other hand, has not showed any side effects for changes in the salt balance, but studies have shown that up to 40% of the patients are not able to drink such a large amount as four litres. Side effects as nausea, vomiting and discomfort are common.
At Ersta hospital we have for many years done research studies on the metabolic response in connection with surgery. Patients undergoing surgery for cancer in the rectum often are prepared with energy drinks in order to receive a higher energy level before the operation. As a result of this the patients often avoid nausea and have a better intestinal function after surgery. We think that this treatment has worked well on the patients but no scientific studies have been done on these patients. As a complementary result of the treatment with nutritional drinks we have found that the colon is empty already after a short time of treatment. We have also prepared some patient for colonoscopy, that due to their primary disease not are able to use traditional purgatives, with nutritional drinks for five days combined with a local purgative on the day of the examination. The colonoscopy examination on these patients were performed without any problems. We have found no studies describing this preparation before colonoscopy.
This is a study that will find out if traditional preparation before colonoscopy could be replaced by nutritional drinks combined with local purgative on the day of the examination.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: LaxabonTraditional bowel preparation with Laxabon |
| B | Active comparator | Dietary Supplement: Fresubin Energy drinkBowel preparation with nutritional drinks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men
- women
- age 18-90 years
Key exclusion criteria (5 listed)
- patients under 18 years
- acute colitis
- acute ileus
- seriously dementia
- patients from other counties
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 |
|---|---|---|
| LaxabonLaxabon 4 litres, starting the day (e.m.) before the colonoscopy | Drug | A |
| Fresubin Energy drink30 kcal/kg*day five days before colonoscopy | Dietary supplement | B |
Primary outcome
Bowel purity degree
Time frame: day of coclonscopy
1 secondary outcome
Reduction of complications for patients with cardio- vascular and kidney diseases
Time frame: day of cocloscopy
Results and safety
The study was stopped early (reason given: The bowel was not clean when the colonoscopy was performed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
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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.
Ulf Gustafsson, PhD, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laxabon and Fresubin Energy drink in people with Colonoscopy and Bowel Preparation, run by Karolinska Institutet at 1 site in Sweden.
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 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: stopped early, as of the sponsor's last update on 18 Sep 2012. 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 Sweden. 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 was stopped early (reason given: The bowel was not clean when the colonoscopy was performed). Results are not available in the source record.
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?
Bowel purity degree (time frame: day of coclonscopy). 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 18 Sep 2012.