Pediatric BurnsPhase 2NCT01605747
Study of Culturelle in the Prophylaxis of Infection and Diarrhea
A Phase 2 study testing Culturelle in people with Pediatric Burns, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
The primary objective of this study is to determine if probiotic prophylaxis has immunologic and gastrointestinal advantages in pediatric burn patients. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Pediatric Burns
- What is being tested?
- Culturelle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2015
- Phase
- Phase 2
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- acute burn injury
- consented within 10 days of injury
- feeding tube present-
Who cannot join
- GI disorder prior to burn
- milk allergy or insensitivity
- non-burned
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Cincinnati, Ohio, 45229
About this study
Official title: A Blinded Placebo Controlled Clinical Outcomes Study of Culturelle® in the Prophylaxis of Infection and Diarrhea
The primary objective of this study is to determine if probiotic prophylaxis has immunologic and gastrointestinal advantages in pediatric burn patients.
- Conditions
- Pediatric Burns
- Being tested
- Culturelle, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CulturelleDietary supplement
one capsule 2x per day per feeding tube
PlaceboDietary supplement
one placebo 2x per day per feeding tube
| Study group | Role | What they receive |
|---|---|---|
| Culturelle | Experimental | Not described Receives: Dietary Supplement: Culturelle |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious outcome
Record incidence of infection between the experimental and placebo groups.
Measured: 3 years
Secondary outcomes (1)
Clinical outcome
Plan to measure clinical outcome between the experimental and placebo groups.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionDec 2015 (estimated)
Why it stopped: Study was stopped due to inavailability of subjects meeting eligibility criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric BurnsStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Gottschlich, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605747
- Sponsor's protocol ID
- 10-12-13-02
- Status last verified
- Nov 2013
- First submitted
- 8 May 2012
- Last updated
- 13 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded Placebo Controlled Clinical Outcomes Study of Culturelle® in the Prophylaxis of Infection and Diarrhea
- ClinicalTrials.gov ID
- NCT01605747
- Acronym / sponsor ID
- 10-12-13-02
- Conditions
- Pediatric Burns
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to inavailability of subjects meeting eligibility criteria.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 May 2012 (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 primary objective of this study is to determine if probiotic prophylaxis has immunologic and gastrointestinal advantages in pediatric burn patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturelle | Experimental | Dietary Supplement: Culturelle |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- acute burn injury
- consented within 10 days of injury
- feeding tube present-
Key exclusion criteria (3 listed)
- GI disorder prior to burn
- milk allergy or insensitivity
- non-burned
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 |
|---|---|---|
| Culturelleone capsule 2x per day per feeding tube | Dietary supplement | Culturelle |
| Placeboone placebo 2x per day per feeding tube | Dietary supplement | Placebo |
Primary outcome
Infectious outcome
Time frame: 3 years
Record incidence of infection between the experimental and placebo groups.
1 secondary outcome
Clinical outcome
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Study was stopped due to inavailability of subjects meeting eligibility criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Culturelle in people with Pediatric Burns, run by Shriners Hospitals for Children at 1 site in United States.
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 3 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 13 Nov 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Study was stopped due to inavailability of subjects meeting eligibility criteria.). 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?
Infectious outcome (time frame: 3 years). 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 13 Nov 2013.