Crohn's DiseasePhase 4NCT00367705
VSL#3 Treatment in Children With Crohn's Disease
A Phase 4 study testing VSL#3® in people with Crohn's Disease, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Crohn's disease (CD) in childhood is a chronic relapsing and remitting condition that has a significant impact on growth and development. The disease is characterized by an increased and unregulated immune response. Read more about this study
- Who is it for?
- Ages 6 to 18 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
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 4
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 6 - 18 years
- Previous diagnosis of Crohn's disease or newly diagnosed with symptoms for at least three months before recruitment to the study.The diagnosis of CD is established by:
- history and symptoms of the disease
- endoscopy/histology or radiology with negative stool culture.
- Written informed consent by parent
- PCDAI > 12.5 and < 30
- Treatment with 5-ASA, budesonide and imuran/6MP daily provided that the dose has remained stable for the 4 weeks (corticosteroids) or 12 weeks (for imuran/6MP) prior to inclusion. Children treated with other medications (such as anti-TNF or antibiotics including ciprofloxacilin or metronidazole) cannot enter this study.
Who cannot join
- Short bowel syndrome/ileostomy/abscess/fistula/small bowel obstruction/stenosis/stricture
- Imminent surgery
- Treatment with anti-TNF, systemic corticosteroids, ciprofloxacillin, metronidazole within 12 weeks of the start of the trial.
- Participation in another clinical trial within the last 30 days.
- Patients should not take antibiotics during the study.
- Patients should not take opioids, cholestyramine, ursodeoxycholic acid during the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization,
Jerusalem, 91120
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Double-blind Placebo Controlled Trial of VSL#3 in Children With Crohn's Disease
Crohn's disease (CD) in childhood is a chronic relapsing and remitting condition that has a significant impact on growth and development. The disease is characterized by an increased and unregulated immune response. The main therapy over the last 30 years has been corticosteroids leading to remission in 50-80% of patients within 2-4 weeks. However, the use of steroids in children is limited by side-effects including acne, moon-face, hirsutism, hypertension, metabolic disturbances and above all reduced growth. Hence, pediatricians are very interested to find alternative therapies. Therapeutic manipulation of gut flora with probiotics promises to be a useful strategy for several disorders including inflammation of the gut. The efficacy of the highly concentrated probiotic VSL#3 has been documented in maintenance and prophylaxis treatment of pouchitis in double blind, placebo controlled studies in adults. The aim of this study is to compare probiotic therapy with VSL#3 versus placebo in maintenance therapy of children with mild to moderate CD, treated with either 5-ASA, corticosteroids (local or budesonide), imuran/6 mercaptopurine (MP), as long as no change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4 weeks (for corticosteroids).
Read the detailed description
The aim of this study is to compare probiotic therapy with VSL#3 versus placebo in maintenance therapy of children with mild to moderate CD, treated with either 5-ASA, corticosteroids (local or budesonide), imuran/6MP, as long as no change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4 weeks (for corticosteroids). The primary goal will be to compare their ability to maintain remission and to decrease disease activity in each of the two study groups. Data will be collected during this 16 week period regarding the safety and tolerability of VSL#3, as well as data of changes in stool composition of microflora upon treatment.
The follow up will be continued for up to 6 months with a monthly telephone questionnaire and a clinical visit at 6 months.
Study Design:
The study will be a multinational, double-blind, randomized controlled study (Munich, Paris, Rotterdam, Porto, Brussels, London, Warsaw, Chicago, Toronto, Boston, New York, Baltimore, Cleveland, Karachi and Jerusalem).
The study will include 300 children and will last for at least 16 weeks. These children will receive either 1-2 packet according to their weight; each sachet containing 900 billion bacteria/day of VSL#3 or an identical placebo, for 16 weeks.
All patients participating in this study will continue regular medications throughout the study period.
According to the Pediatric Crohn's Disease Activity Index (PCDAI) patients will be assessed clinically at regular intervals and will have stool cultured (including lactobacillus, bifidobacteria and Strep salivarius) as well as a stool calprotectin before and after treatment.
- Conditions
- Crohn's Disease
- Being tested
- VSL#3®, Placebo
- 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#3®Dietary supplement
1-2 sachets/day per os, 6 months
PlaceboDietary supplement
Also called placebo powder
1-2 sachets/day per os, 6 months
| Study group | Role | What they receive |
|---|---|---|
| T | Active comparator | VSL-#3 Receives: Dietary Supplement: VSL#3® |
| P | 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.
remission
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 posted23 Aug 2006 (estimated)
- Study startAug 2009
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- David Branski, MD, Study director, Hadassah Medical OrganizationMichael Wilschanski, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367705
- Sponsor's protocol ID
- VSL-HMO-CTIL
- Status last verified
- Aug 2006
- First submitted
- 22 Aug 2006
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gionchetti P, Rizzello F, Lammers KM, Morselli C, Sollazzi L, Davies S, Tambasco R, Calabrese C, Campieri M. Antibiotics and probiotics in treatment of inflammatory bowel disease. World J Gastroenterol. 2006 Jun 7;12(21):3306-13. doi: 10.3748/wjg.v12.i21.3306.
PubMed 16733845
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo Controlled Trial of VSL#3 in Children With Crohn's Disease
- ClinicalTrials.gov ID
- NCT00367705
- Acronym / sponsor ID
- VSL-HMO-CTIL
- Conditions
- Crohn's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 23 Aug 2006 (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.
Crohn's disease (CD) in childhood is a chronic relapsing and remitting condition that has a significant impact on growth and development. The disease is characterized by an increased and unregulated immune response. The main therapy over the last 30 years has been corticosteroids leading to remission in 50-80% of patients within 2-4 weeks. However, the use of steroids in children is limited by side-effects including acne, moon-face, hirsutism, hypertension, metabolic disturbances and above all reduced growth. Hence, pediatricians are very interested to find alternative therapies. Therapeutic manipulation of gut flora with probiotics promises to be a useful strategy for several disorders including inflammation of the gut. The efficacy of the highly concentrated probiotic VSL#3 has been documented in maintenance and prophylaxis treatment of pouchitis in double blind, placebo controlled studies in adults. The aim of this study is to compare probiotic therapy with VSL#3 versus placebo in maintenance therapy of children with mild to moderate CD, treated with either 5-ASA, corticosteroids (local or budesonide), imuran/6 mercaptopurine (MP), as long as no change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4 weeks (for corticosteroids).
Detailed description
The aim of this study is to compare probiotic therapy with VSL#3 versus placebo in maintenance therapy of children with mild to moderate CD, treated with either 5-ASA, corticosteroids (local or budesonide), imuran/6MP, as long as no change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4 weeks (for corticosteroids). The primary goal will be to compare their ability to maintain remission and to decrease disease activity in each of the two study groups. Data will be collected during this 16 week period regarding the safety and tolerability of VSL#3, as well as data of changes in stool composition of microflora upon treatment.
The follow up will be continued for up to 6 months with a monthly telephone questionnaire and a clinical visit at 6 months.
Study Design:
The study will be a multinational, double-blind, randomized controlled study (Munich, Paris, Rotterdam, Porto, Brussels, London, Warsaw, Chicago, Toronto, Boston, New York, Baltimore, Cleveland, Karachi and Jerusalem).
The study will include 300 children and will last for at least 16 weeks. These children will receive either 1-2 packet according to their weight; each sachet containing 900 billion bacteria/day of VSL#3 or an identical placebo, for 16 weeks.
All patients participating in this study will continue regular medications throughout the study period.
According to the Pediatric Crohn's Disease Activity Index (PCDAI) patients will be assessed clinically at regular intervals and will have stool cultured (including lactobacillus, bifidobacteria and Strep salivarius) as well as a stool calprotectin before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T | Active comparator | Dietary Supplement: VSL#3®VSL-#3 |
| P | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children aged 6 - 18 years
- Previous diagnosis of Crohn's disease or newly diagnosed with symptoms for at least three months before recruitment to the study.The diagnosis of CD is established by:
- Written informed consent by parent
- PCDAI > 12.5 and < 30
- Treatment with 5-ASA, budesonide and imuran/6MP daily provided that the dose has remained stable for the 4 weeks (corticosteroids) or 12 weeks (for imuran/6MP) prior to inclusion. Children treated with other medications (such as anti-TNF or antibiotics including ciprofloxacilin or metronidazole) cannot enter this study.
Key exclusion criteria (6 listed)
- Short bowel syndrome/ileostomy/abscess/fistula/small bowel obstruction/stenosis/stricture
- Imminent surgery
- Treatment with anti-TNF, systemic corticosteroids, ciprofloxacillin, metronidazole within 12 weeks of the start of the trial.
- Participation in another clinical trial within the last 30 days.
- Patients should not take antibiotics during the 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 |
|---|---|---|
| VSL#3®1-2 sachets/day per os, 6 months | Dietary supplement | T |
| PlaceboAlso: placebo powder1-2 sachets/day per os, 6 months | Dietary supplement | P |
Primary outcome
remission
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 18 Aug 2009.
- Background: PubMed 16733845Gionchetti P, Rizzello F, Lammers KM, Morselli C, Sollazzi L, Davies S, Tambasco R, Calabrese C, Campieri M. Antibiotics and probiotics in treatment of inflammatory bowel disease. World J Gastroenterol. 2006 Jun 7;12(21):3306-13. doi: 10.3748/wjg.v12.i21.3306.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
David Branski, MD study director
Hadassah Medical Organization
Michael Wilschanski, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VSL#3® in people with Crohn's Disease, run by Hadassah Medical Organization at 1 site in Israel.
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 7 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: status not confirmed, as of the sponsor's last update on 18 Aug 2009. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 David Branski, MD (00972-2-6777543, branski@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission (time frame: 1 year). 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 NCT00367705, which also lists 1 linked publication.
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 18 Aug 2009.