Gastrointestinal DiseasesPhase 3NCT01191112
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
A Phase 3 study testing Peptide based enteral formula in people with Gastrointestinal Diseases and Feeding Intolerance, run by Abbott Nutrition at 1 site in Canada.
Trial summary
The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Gastrointestinal Diseases, Feeding Intolerance
- What is being tested?
- Peptide based enteral formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Nov 2011
- Phase
- Phase 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 1 year to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or nonpregnant female between 1 and 13 years of age.
- Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance.
- Subject requires enteral tube feeding as sole source of nutrition.
Who cannot join
- History of diabetes.
- Requires artificial ventilation.
- Requires parenteral nutrition.
- Subject has intestinal obstruction.
- Subject is receiving dialysis treatment.
- Subject has an allergy or intolerance to any ingredient in the study product.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta, Stollery Children's Hospital
Edmonton, Alberta, T6G2J3
About this study
The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.
- Conditions
- Gastrointestinal Diseases, Feeding Intolerance
- Being tested
- Peptide based enteral formula
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide based enteral formulaOther
Sole source nutrition as per HCP
| Study group | Role | What they receive |
|---|---|---|
| Peptide Based enteral formula | Experimental | Not described Receives: Other: Peptide based enteral formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Measured: 14 Days
Frequency and intensity of irritability, vomiting, distension
Measured: 14 Days
Secondary outcomes (3)
Average Energy Intake
Measured: 14 Days
Anthropometrics
Measured: 14 Days
Medication Use
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Williams, MPH, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191112
- Sponsor's protocol ID
- BK87
- Status last verified
- Mar 2015
- First submitted
- 27 Aug 2010
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
- ClinicalTrials.gov ID
- NCT01191112
- Acronym / sponsor ID
- BK87
- Conditions
- Gastrointestinal Diseases, Feeding Intolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Aug 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 objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptide Based enteral formula | Experimental | Other: Peptide based enteral formula |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or nonpregnant female between 1 and 13 years of age.
- Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance.
- Subject requires enteral tube feeding as sole source of nutrition.
Key exclusion criteria (6 listed)
- History of diabetes.
- Requires artificial ventilation.
- Requires parenteral nutrition.
- Subject has intestinal obstruction.
- Subject is receiving dialysis treatment.
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 |
|---|---|---|
| Peptide based enteral formulaSole source nutrition as per HCP | Other | Peptide Based enteral formula |
Primary outcome
Stool frequency
Time frame: 14 Days
Frequency and intensity of irritability, vomiting, distension
Time frame: 14 Days
3 secondary outcomes
Average Energy Intake
Time frame: 14 Days
Anthropometrics
Time frame: 14 Days
Medication Use
Time frame: 14 days
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 3 Mar 2015.
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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.
Jennifer Williams, MPH study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peptide based enteral formula in people with Gastrointestinal Diseases and Feeding Intolerance, run by Abbott Nutrition at 1 site in Canada.
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 6 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 3 Mar 2015. 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 Canada. 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 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?
Stool frequency (time frame: 14 Days). The study lists 2 primary outcomes in all. 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 3 Mar 2015.