ObstipationNCT01473966
Coffee Against Obstipation in Intensive Care Treatment
A study testing coffee and coffee rectally in people with Obstipation, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit (ICU) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstipation
- What is being tested?
- coffee and coffee rectally
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admission to the medical intensive care unit of the Dept. of Gastroenterology at the university hospital heidelberg
- requires ventilator support for an anticipated more than 72 hours
- age older than 18 years
Who cannot join
- pregnancy
- known allergy to coffee
- mechanical ileus
- presence of enterostoma
Trial locations and contacts
1 site in 1 country.
About this study
Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit (ICU) patients.
Read the detailed description
Critically ill patients requiring ventilator support frequently suffer from obstipation. We hypothesize that coffee, administered either orally or rectally, might stimulate bowel movement.
- Conditions
- Obstipation
- Being tested
- coffee, coffee rectally
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coffeeDietary supplement
patients will receive a cup of coffee at room temperature orally twice daily
coffee rectallyDietary supplement
Also called Coffee
patients receive an enema of two cups of coffee at room temperature once daily
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | patients receive standard care |
| Coffee orally | Experimental | patients will receive standard of care plus coffee orally Receives: Dietary Supplement: coffee |
| coffee rectally | Experimental | patients receive standard of care plus coffee rectally Receives: Dietary Supplement: coffee rectally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel movement rate
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes (5)
time on mechanical ventilation
Measured: participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks
time of stay on ICU
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
lengths of hospitalisation
Measured: an average of 5 weeks of hospital stay is expected
in hospital mortality
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
long term mortality
Measured: 6 months following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObstipationStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Eisenbach, University Hospital Heidelberg
- Investigators
- Christoph Eisenbach, Principal investigator, University of Heidelberg, Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473966
- Sponsor's protocol ID
- COFFEE
- Status last verified
- Nov 2011
- First submitted
- 10 Nov 2011
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee Against Obstipation in Intensive Care Treatment
- ClinicalTrials.gov ID
- NCT01473966
- Acronym / sponsor ID
- COFFEE
- Conditions
- Obstipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 17 Nov 2011 (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.
Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit (ICU) patients.
Detailed description
Critically ill patients requiring ventilator support frequently suffer from obstipation. We hypothesize that coffee, administered either orally or rectally, might stimulate bowel movement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | –patients receive standard care |
| Coffee orally | Experimental | Dietary Supplement: coffeepatients will receive standard of care plus coffee orally |
| coffee rectally | Experimental | Dietary Supplement: coffee rectallypatients receive standard of care plus coffee rectally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admission to the medical intensive care unit of the Dept. of Gastroenterology at the university hospital heidelberg
- requires ventilator support for an anticipated more than 72 hours
- age older than 18 years
Key exclusion criteria (4 listed)
- pregnancy
- known allergy to coffee
- mechanical ileus
- presence of enterostoma
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 |
|---|---|---|
| coffeepatients will receive a cup of coffee at room temperature orally twice daily | Dietary supplement | Coffee orally |
| coffee rectallyAlso: Coffeepatients receive an enema of two cups of coffee at room temperature once daily | Dietary supplement | coffee rectally |
Primary outcome
Bowel movement rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
5 secondary outcomes
time on mechanical ventilation
Time frame: participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks
time of stay on ICU
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
lengths of hospitalisation
Time frame: an average of 5 weeks of hospital stay is expected
in hospital mortality
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
long term mortality
Time frame: 6 months following discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
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.
Christoph Eisenbach principal investigator
University of Heidelberg, Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coffee and coffee rectally in people with Obstipation, run by University Hospital Heidelberg at 1 site in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 17 Nov 2011. 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 Germany. 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?
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 movement rate (time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks). 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 17 Nov 2011.