Acute PancreatitisNCT01249963
Enteral Nutrition Product in Mild Acute Pancreatitis
A study testing T-Diet plus Atémpero and AlitraQ (Abbott) in people with Acute Pancreatitis and Enteral Nutrition, run by Vegenat, S.A. at 1 site in Spain.
Trial summary
The aim of the study is to evaluate the beneficial effects of the administration of enteral nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and medium chain triglycerides (MCT) in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Enteral Nutrition
- What is being tested?
- T-Diet plus Atémpero and AlitraQ (Abbott)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2011to Mar 2013
- 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
- Patients over 18 with Mild Acute Pancreatitis.
Who cannot join
- Patients with Several Acute Pancreatitis
- Patients with life expectancy less than 48 hours.
- Renal (creatinin > 2,5 mg/dl) or kidney failure (GOT/GPT>2 from laboratory normal value)
- Patients with diabetes mellitus prior to acute pancreatitis.
- To take part in another study.
- Pregnant patients
- Informed consent absence.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón
Madrid, Madrid, 28007
Cristina Velasco Gimeno, BA, +34 91 586 71 64, cvelasco.hgugm@salud.madrid.org
About this study
Official title: Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis
The aim of the study is to evaluate the beneficial effects of the administration of enteral nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All this against other specific product.
The main objectives of this project are:
- Comparing the tolerance of both preparations.
- Comparing the evolution of nutritional status in both groups.
- Comparing the evolution of inflammatory parameters in both groups
Read the detailed description
Oral administration of an oligomeric formula with milk proteins, mainly whey protein partially hydrolysate, monounsaturated fatty acids (AGM) and low dextrose equivalent maltodextrin and enriched in polyunsaturated fatty acids (PUFA) of omega-3 series, EPA and DHA, and MCT designed for nutritional support of patients with compromised intestinal function, to maintain or improve nutritional status and reduce the inflammatory response in undernourished patients with mild acute pancreatitis, compared with oligomeric enteral nutrition product, low in fat and rich in glutamine.
- Conditions
- Acute Pancreatitis, Enteral Nutrition
- Being tested
- T-Diet plus Atémpero, AlitraQ (Abbott)
- Keywords
- acute pancreatitis, enteral nutrition, nutritional status, pancreas, T-Diet plus Atémpero
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Diet plus AtémperoDietary supplement
Also called ATEMP
T-Diet plus Atémpero is a complete normocaloric and normoproteic enteral nutrition product for the dietary management of patients with mild acute pancreatitis.
AlitraQ (Abbott)Dietary supplement
Also called ALIT
AlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days. Receives: Dietary Supplement: T-Diet plus Atémpero |
| Control Diet | Active comparator | Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days. Receives: Dietary Supplement: AlitraQ (Abbott) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance, Tolerance and Nutritional Status
- To compare the acceptance and tolerance of both products.
- To compare the nutritional status in both arms.
Measured: 1 year
Secondary outcomes (1)
Inflammatory parameters evolution and EN complications
- To compare the inflammatory parameters evolution in both arms.
- To evaluate the enteral nutrition complications.
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 posted30 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vegenat, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pilar García-Peris, PhD, Principal investigator, Hospital Universitario Gregorio Marañón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249963
- Sponsor's protocol ID
- ATEM2010
- Other IDs
- Atémpero IDI-20080283
- Status last verified
- Feb 2011
- First submitted
- 26 Nov 2010
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01249963
- Acronym / sponsor ID
- ATEM2010
- Conditions
- Acute Pancreatitis, Enteral Nutrition
- Keywords
- acute pancreatitis, enteral nutrition, nutritional status, pancreas, T-Diet plus Atémpero
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vegenat, S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 30 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 aim of the study is to evaluate the beneficial effects of the administration of enteral nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All this against other specific product.
The main objectives of this project are:
- Comparing the tolerance of both preparations.
- Comparing the evolution of nutritional status in both groups.
- Comparing the evolution of inflammatory parameters in both groups
Detailed description
Oral administration of an oligomeric formula with milk proteins, mainly whey protein partially hydrolysate, monounsaturated fatty acids (AGM) and low dextrose equivalent maltodextrin and enriched in polyunsaturated fatty acids (PUFA) of omega-3 series, EPA and DHA, and MCT designed for nutritional support of patients with compromised intestinal function, to maintain or improve nutritional status and reduce the inflammatory response in undernourished patients with mild acute pancreatitis, compared with oligomeric enteral nutrition product, low in fat and rich in glutamine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: T-Diet plus AtémperoPatients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days. |
| Control Diet | Active comparator | Dietary Supplement: AlitraQ (Abbott)Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 with Mild Acute Pancreatitis.
Key exclusion criteria (7 listed)
- Patients with Several Acute Pancreatitis
- Patients with life expectancy less than 48 hours.
- Renal (creatinin > 2,5 mg/dl) or kidney failure (GOT/GPT>2 from laboratory normal value)
- Patients with diabetes mellitus prior to acute pancreatitis.
- To take part in another study.
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 |
|---|---|---|
| T-Diet plus AtémperoAlso: ATEMPT-Diet plus Atémpero is a complete normocaloric and normoproteic enteral nutrition product for the dietary management of patients with mild acute pancreatitis. | Dietary supplement | Experimental Group |
| AlitraQ (Abbott)Also: ALITAlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine. | Dietary supplement | Control Diet |
Primary outcome
Acceptance, Tolerance and Nutritional Status
Time frame: 1 year
* To compare the acceptance and tolerance of both products. * To compare the nutritional status in both arms.
1 secondary outcome
Inflammatory parameters evolution and EN complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 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.
Pilar García-Peris, PhD principal investigator
Hospital Universitario Gregorio Marañón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-Diet plus Atémpero and AlitraQ (Abbott) in people with Acute Pancreatitis and Enteral Nutrition, run by Vegenat, S.A. at 1 site in Spain.
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 1 inclusion and 7 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 22 Jun 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 Spain. 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?
Contact Cristina Velasco Gimeno, BA (+34 91 586 71 64, cvelasco.hgugm@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance, Tolerance and Nutritional Status (time frame: 1 year). 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 22 Jun 2012.