Crohn's DiseasePhase 3NCT00944736
Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease
A Phase 3 study testing VSL#3 in people with Crohn's Disease, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on intestinal permeability in pediatric patients with Crohn's disease. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- VSL#3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2013
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Current diagnosis of small bowel or colonic Crohn's disease as defined by histological and endoscopic criteria.
- Males or females ages 11-17 years.
- Crohn's disease in remission as defined by a Pediatric Crohn's Disease Activity Index (PCDAI) < 10
- Patients on maintenance doses of aminosalicylates, 6-MP and/or Azathioprine for at least 2 months.
- Procurement of written informed consent signed by the subject's legal guardian and study investigator(s) and patient assent.
Who cannot join
- Patients with documented intestinal stricture.
- Patients with signs of symptoms of systemic or intestinal infection.
- Antibiotic use the previous 1 month.
- Probiotic use in the previous 2 months (excluding yogurt).
- Use of the following medications; Methotrexate, Cyclosporine, Tacrolimus and Infliximab.
- Patients with diagnosis of other co-morbid diseases such as heart disease, renal disease, immunodeficiency, diabetes, or thyroid disease.
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- Patients with indwelling catheters.
- Patients with short bowel syndrome
- Positive urine pregnancy test for female subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission
The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on intestinal permeability in pediatric patients with Crohn's disease.
Read the detailed description
Children with Crohn's disease have altered intestinal permeability. A pilot study in children showed that probiotics may decrease intestinal permeability. In this double blind, randomized controlled trial, we will observe the effect of VSL#3 on small bowel permeability using a double sugar absorption test. PCDAI was monitored, but not analyzed.
- Conditions
- Crohn's Disease
- Being tested
- VSL#3, Placebo
- Keywords
- Crohn's Disease, Pediatric, VSL#3, Permeability, Probiotic, Zonulin
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Dietary supplement
1 packet BID
PlaceboDietary supplement
1 inactive packet BID
| Study group | Role | What they receive |
|---|---|---|
| VSL#3 | Active comparator | Not described Receives: Dietary Supplement: VSL#3 |
| 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.
Intestinal Permeability - measured by Sugar Absorption Test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- VSL Pharmaceuticals
- Responsible party
- Principal investigator, Julia Bracken, Children's Mercy Hospital Kansas City
- Investigators
- Julia M Bracken, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944736
- Sponsor's protocol ID
- 09 06-115
- Status last verified
- Mar 2014
- First submitted
- 22 Jul 2009
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission
- ClinicalTrials.gov ID
- NCT00944736
- Acronym / sponsor ID
- 09 06-115
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Pediatric, VSL#3, Permeability, Probiotic, Zonulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- VSL Pharmaceuticals
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Jul 2009 (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 purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on intestinal permeability in pediatric patients with Crohn's disease.
Detailed description
Children with Crohn's disease have altered intestinal permeability. A pilot study in children showed that probiotics may decrease intestinal permeability. In this double blind, randomized controlled trial, we will observe the effect of VSL#3 on small bowel permeability using a double sugar absorption test. PCDAI was monitored, but not analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSL#3 | Active comparator | Dietary Supplement: VSL#3 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Current diagnosis of small bowel or colonic Crohn's disease as defined by histological and endoscopic criteria.
- Males or females ages 11-17 years.
- Crohn's disease in remission as defined by a Pediatric Crohn's Disease Activity Index (PCDAI) < 10
- Patients on maintenance doses of aminosalicylates, 6-MP and/or Azathioprine for at least 2 months.
- Procurement of written informed consent signed by the subject's legal guardian and study investigator(s) and patient assent.
Key exclusion criteria (9 listed)
- Patients with documented intestinal stricture.
- Patients with signs of symptoms of systemic or intestinal infection.
- Antibiotic use the previous 1 month.
- Probiotic use in the previous 2 months (excluding yogurt).
- Use of the following medications; Methotrexate, Cyclosporine, Tacrolimus and Infliximab.
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 |
|---|---|---|
| VSL#31 packet BID | Dietary supplement | VSL#3 |
| Placebo1 inactive packet BID | Dietary supplement | Placebo |
Primary outcome
Intestinal Permeability - measured by Sugar Absorption Test
Time frame: 3 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 10 Mar 2014.
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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.
Julia M Bracken, MD principal investigator
Children's Mercy Hospital Kansas City
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 VSL#3 in people with Crohn's Disease, run by Children's Mercy Hospital Kansas City 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 5 inclusion and 9 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 10 Mar 2014. 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 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?
Intestinal Permeability - measured by Sugar Absorption Test (time frame: 3 months). 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 10 Mar 2014.