Acute PancreatitisPhase 2/3MIMOSANCT01128478
MIld to MOderate Acute Pancreatitis: Early naSogastric Tube Feeding Compared With pAncreas Rest (MIMOSA)
A Phase 2/3 study testing Enteral tube feeding in people with Acute Pancreatitis, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute pancreatitis. The study hypothesis is that early administered enteral tube feeding might reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Enteral tube feeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 2010to Apr 2012
- Phase
- Phase 2/3
- 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
- diagnosis of acute pancreatitis
- age 18 years or older
- written informed consent
Who cannot join
- > 96 hours after onset of symptoms
- > 24 hours after hospital admission
- organ failure by the time of randomization
- infectious complications before randomization
- received artificial nutrition before randomization
- previously enrolled into the trial
Show all 11Show fewer
- chronic pancreatitis
- post-ERCP pancreatitis
- intraoperative diagnosis of acute pancreatitis
- pregnancy
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial
Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute pancreatitis. The study hypothesis is that early administered enteral tube feeding might reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute pancreatitis.
- Conditions
- Acute Pancreatitis
- Being tested
- Enteral tube feeding
- Keywords
- Acute pancreatitis, Enteral nutrition, Pancreas rest
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral tube feedingProcedure or surgery
Nasogastric tube feeding started within 24 h of hospital admission
| Study group | Role | What they receive |
|---|---|---|
| Enteral tube feeding | Other | Nasogastric tube feeding started within 24 h of hospital admission Receives: Procedure: Enteral tube feeding |
| Nil-per-mouth regimen | No intervention | Conventional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: Up to 3 months
Secondary outcomes (8)
Pain relapse
Measured: Up to 3 months
Local and systemic complications
Measured: Up to 3 months
Feeding intolerance
Measured: Up to 3 months
Time to solid oral food tolerated
Measured: Approx. one week
Pain-free time
Measured: Up to 3 months
Hospital readmission
Measured: Up to 6 months
Quality of life
Measured: Up to 6 months
Mortality
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Petrov, University of Auckland, New Zealand
- Investigators
- Max Petrov, MD, MPH (Epi), Principal investigator, Universioty of Auckland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128478
- Sponsor's protocol ID
- NTX/08/11/107
- Acronym
- MIMOSA
- Status last verified
- Jan 2013
- First submitted
- 11 May 2010
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Petrov MS. Enteral nutrition: goody or good-for-nothing in acute pancreatitis? Am J Gastroenterol. 2007 Aug;102(8):1828-9; author reply 1829-30. doi: 10.1111/j.1572-0241.2007.01361.x. No abstract available.
PubMed 17686077Petrov MS, van Santvoort HC, Besselink MG, Cirkel GA, Brink MA, Gooszen HG. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol. 2007 Sep;102(9):2079-84; quiz 2085. doi: 10.1111/j.1572-0241.2007.01357.x. Epub 2007 Jun 16.
PubMed 17573797Petrov MS. To feed or not to feed early in acute pancreatitis: still depend on severity? Clin Nutr. 2008 Apr;27(2):317-8. doi: 10.1016/j.clnu.2008.01.011. Epub 2008 Mar 10. No abstract available.
PubMed 18331767Petrov MS, McIlroy K, Grayson L, Phillips AR, Windsor JA. Early nasogastric tube feeding versus nil per os in mild to moderate acute pancreatitis: a randomized controlled trial. Clin Nutr. 2013 Oct;32(5):697-703. doi: 10.1016/j.clnu.2012.12.011. Epub 2012 Dec 31.
PubMed 23340042
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01128478
- Acronym / sponsor ID
- MIMOSA / NTX/08/11/107
- Conditions
- Acute Pancreatitis
- Keywords
- Acute pancreatitis, Enteral nutrition, Pancreas rest
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 May 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.
Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute pancreatitis. The study hypothesis is that early administered enteral tube feeding might reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute pancreatitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral tube feeding | Other | Procedure: Enteral tube feedingNasogastric tube feeding started within 24 h of hospital admission |
| Nil-per-mouth regimen | No intervention | –Conventional management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of acute pancreatitis
- age 18 years or older
- written informed consent
Key exclusion criteria (11 listed)
- > 96 hours after onset of symptoms
- > 24 hours after hospital admission
- organ failure by the time of randomization
- infectious complications before randomization
- received artificial nutrition before randomization
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 |
|---|---|---|
| Enteral tube feedingNasogastric tube feeding started within 24 h of hospital admission | Procedure or surgery | Enteral tube feeding |
Primary outcome
Length of hospital stay
Time frame: Up to 3 months
8 secondary outcomes
Pain relapse
Time frame: Up to 3 months
Local and systemic complications
Time frame: Up to 3 months
Feeding intolerance
Time frame: Up to 3 months
Time to solid oral food tolerated
Time frame: Approx. one week
Pain-free time
Time frame: Up to 3 months
Hospital readmission
Time frame: Up to 6 months
Quality of life
Time frame: Up to 6 months
Mortality
Time frame: Up to 6 months
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 8 Jan 2013.
- Background: PubMed 17686077Petrov MS. Enteral nutrition: goody or good-for-nothing in acute pancreatitis? Am J Gastroenterol. 2007 Aug;102(8):1828-9; author reply 1829-30. doi: 10.1111/j.1572-0241.2007.01361.x. No abstract available.
- Background: PubMed 17573797Petrov MS, van Santvoort HC, Besselink MG, Cirkel GA, Brink MA, Gooszen HG. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol. 2007 Sep;102(9):2079-84; quiz 2085. doi: 10.1111/j.1572-0241.2007.01357.x. Epub 2007 Jun 16.
- Background: PubMed 18331767Petrov MS. To feed or not to feed early in acute pancreatitis: still depend on severity? Clin Nutr. 2008 Apr;27(2):317-8. doi: 10.1016/j.clnu.2008.01.011. Epub 2008 Mar 10. No abstract available.
- Derived from this study: PubMed 23340042Petrov MS, McIlroy K, Grayson L, Phillips AR, Windsor JA. Early nasogastric tube feeding versus nil per os in mild to moderate acute pancreatitis: a randomized controlled trial. Clin Nutr. 2013 Oct;32(5):697-703. doi: 10.1016/j.clnu.2012.12.011. Epub 2012 Dec 31.
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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.
Max Petrov, MD, MPH (Epi) principal investigator
Universioty of Auckland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Enteral tube feeding in people with Acute Pancreatitis, run by University of Auckland, New Zealand at 1 site in New Zealand.
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 8 Jan 2013. 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 New Zealand. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Length of hospital stay (time frame: Up to 3 months). 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 NCT01128478, which also lists 4 linked publications.
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 8 Jan 2013.