Irritable Bowel SyndromePhase 2POPSIINCT00793494
Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years
A Phase 2 study testing Probaclac in people with Irritable Bowel Syndrome, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The aim of this study is to determine the efficacy of the administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Probaclac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to May 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 8 to 18 years
- Irritable bowel syndrome according to Rome III criteria
Who cannot join
- Not able to collaborate
- Known Digestive malformation
- History of digestive surgery (except hernia repair and appendectomy)
- History of known digestive disease (Crohn's, ulcerative colitis, esophagitis, peptic ulcer, celiac disease)
- Symptoms suggestive of organic disease (such as rectal bleeding, weight loss
- History of chronic extra-digestive disease
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- Acute gastroenteritis in th e4 weeks prior to inclusion
- Central catheter, artificial cardiac valve, endocardiac prothesis
- Current Antidepressant treatment
- Patients taking a treatment for irritable bowel syndrome unable to cease their current treatment
- Patient taking regularly probiotics and natural products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome
The aim of this study is to determine the efficacy of the administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome versus placebo.
This study is a double-blind randomized controlled study. 84 children will included. After inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are followed for a 2-week period of follow-up.
4 visits and 4 phone calls are planned during the study.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Probaclac, Placebo
- Keywords
- Irritable bowel syndrome, Children, Pediatrics, Probiotics
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbaclacOther
Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™)
PlaceboOther
Placebo composition matodextrin, gelatin, ascorbic acid, soya
| Study group | Role | What they receive |
|---|---|---|
| Probaclac | Experimental | Administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) b.i.d. Receives: Other: Probaclac |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective assessment of improvement of symptoms
Measured: 4 weeks
Secondary outcomes (7)
Change in severity of symptoms (likert scale)
Measured: 4 weeks
Presence and intensity of pain episodes
Measured: 4 weeks
Presence or absence of urgency, incomplete evacuation, gas
Measured: 4 weeks
Number and consistance of the stools
Measured: 4 weeks
School and social absenteism
Measured: 4 weeks
Quality of Life
Measured: 4 weeks
Adverse Events
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Recruitment impossible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nicar Inc.
- Responsible party
- Principal investigator, Christophe Faure, St. Justine's Hospital
- Investigators
- Christophe M Faure, MD, Principal investigator, Ste-Justine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793494
- Sponsor's protocol ID
- Probaclac-HSJ
- Acronym
- POPSII
- Status last verified
- Apr 2016
- First submitted
- 17 Nov 2008
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00793494
- Acronym / sponsor ID
- POPSII / Probaclac-HSJ
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Children, Pediatrics, Probiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment impossible
- Enrolment
- 44 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Nicar Inc.
- Study start
- Jan 2009
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Nov 2008 (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 this study is to determine the efficacy of the administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome versus placebo.
This study is a double-blind randomized controlled study. 84 children will included. After inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are followed for a 2-week period of follow-up.
4 visits and 4 phone calls are planned during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probaclac | Experimental | Other: ProbaclacAdministration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) b.i.d. |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children 8 to 18 years
- Irritable bowel syndrome according to Rome III criteria
Key exclusion criteria (11 listed)
- Not able to collaborate
- Known Digestive malformation
- History of digestive surgery (except hernia repair and appendectomy)
- History of known digestive disease (Crohn's, ulcerative colitis, esophagitis, peptic ulcer, celiac disease)
- Symptoms suggestive of organic disease (such as rectal bleeding, weight loss
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 |
|---|---|---|
| ProbaclacBifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) | Other | Probaclac |
| PlaceboPlacebo composition matodextrin, gelatin, ascorbic acid, soya | Other | Placebo |
Primary outcome
Subjective assessment of improvement of symptoms
Time frame: 4 weeks
7 secondary outcomes
Change in severity of symptoms (likert scale)
Time frame: 4 weeks
Presence and intensity of pain episodes
Time frame: 4 weeks
Presence or absence of urgency, incomplete evacuation, gas
Time frame: 4 weeks
Number and consistance of the stools
Time frame: 4 weeks
School and social absenteism
Time frame: 4 weeks
Quality of Life
Time frame: 4 weeks
Adverse Events
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Recruitment impossible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Related InfoLink provided by the sponsor.
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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.
Christophe M Faure, MD principal investigator
Ste-Justine Hospital
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 Probaclac in people with Irritable Bowel Syndrome, run by St. Justine's Hospital 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 2 inclusion and 11 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 Apr 2016. 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. 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: Recruitment impossible). 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?
Subjective assessment of improvement of symptoms (time frame: 4 weeks). 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 Apr 2016.