GastroenteritisPhase 2NCT00760773
Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance
A Phase 2 study testing Lacidophil (experimental high dose) and Lacidophil (experimental standard dose) in people with Gastroenteritis, run by The Hospital for Sick Children at 3 sites in Canada.
Trial summary
The objective of this study is to determine for previously healthy children, who present to an ED with acute gastroenteritis, if the probability of daycare absenteeism is significantly different in those who receive a probiotic agent compared to those who receive placebo. Read more about this study
- Who is it for?
- Ages 4 to 48 months
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Lacidophil (experimental high dose) and Lacidophil (experimental standard dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2009to Mar 2014
- 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 4 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acute gastroenteritis as determined by the supervising physician.
- Attend daycare
- Presence of diarrhea.
- Duration of vomiting or diarrhea less than 96 hours.
- Age greater than 90 days
- Age less than 48 months
Who cannot join
- Presence of an indwelling vascular access line or congenital heart disease.
- Taking immunosuppressive therapy or history of immunodeficiency (including all primary, secondary and acquired states)
- Have recently had cardiac, oral or gastrointestinal surgery
- Pancreatic dysfunction or bloody diarrhea
- History of: hematochezia, underlying chronic gastrointestinal problem, short bowel syndrome or inflammatory bowel disease
- Family member with an indwelling vascular access line, on immunosuppressive therapy or with a known immunodeficiency
Show all 11Show fewer
- Undergoing radiation therapy
- Exclusively breastfed
- Bilious or bloody vomitus
- Previously enrolled in this trial
- Inability to speak or read English
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hospital Sainte Justine
Montreal, Quebec
Children's Hospital of Eastern Ontario
Ottawa, Ontario
The Hospital for Sick Children
Toronto, Ontario
About this study
Official title: Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance: Randomized Controlled Trial and Economic Analysis
The objective of this study is to determine for previously healthy children, who present to an ED with acute gastroenteritis, if the probability of daycare absenteeism is significantly different in those who receive a probiotic agent compared to those who receive placebo.
Read the detailed description
Gastroenteritis in children utilizes significant health care resources and has a significant impact on children, caregivers and society. In the United States, gastroenteritis accounts for more than 1.5 million outpatient visits and 200,000 hospitalizations per year. Data from British Columbia indicate that gastroenteritis annually accounts for 12 million missed workdays by adults and 10 million missed school days by children in this province alone. Canadian data, including the cost of work absenteeism, report the mean annual cost/gastroenteritis case to be $1,089.
Although medications have not routinely been recommended, acute gastroenteritis in children can result in significant morbidity. Thus, physicians and caregivers desire treatment options to reduce the burden of disease. Recently, ondansetron, an antiemetic agent has been found to be effective in pediatric gastroenteritis, and is now frequently employed to reduce vomiting. Probiotics agents may represent another valuable treatment option. Since the early 1990s, research has been conducted on the effects of probiotics, defined as viable microbial preparations that have a beneficial effect on the health and well being of the host.
A recent Cochrane Database systematic review recently concluded that "probiotics appear to be a useful adjunct to rehydration therapy in treating acute, infectious diarrhea." However, the review also concluded that more research is needed to determine which specific probiotic regimens should be employed in specific patient groups. The later statement is of particular importance in North America as probiotics are not a mainstay of clinical practice. While only 18% of Canadian physicians are aware of research on probiotics, 82% feel that more probiotic research is needed, and 76% feel there is a role for probiotics in their practice. This discrepancy likely is due to the absence of probiotic trials in North American patients and because the outcome measures evaluated often have had limited clinical applicability. Since most episodes of acute diarrhea require no specific treatment, cost-effectiveness analyses are also required before the widespread use of probiotics can be endorsed.
- Conditions
- Gastroenteritis
- Being tested
- Lacidophil (experimental high dose), Lacidophil (experimental standard dose), Placebo
- Keywords
- Probiotic treatment, Daycare attendance, Pediatric, Emergency department
- Medical subject headings
- Gastroenteritis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacidophil (experimental high dose)Drug
Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the high dose which will consist of 4 billion CFU (1 active sachet) PO BID (total daily dose = 8 billion CFU) x 5 days.
Lacidophil (experimental standard dose)Drug
Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the standard dose which will consist of 4 billion CFU (1 active sachet) PO QAM (total daily dose = 4 billion CFU) plus 1 placebo sachet PO QHS x 5 days.
PlaceboDrug
The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Lacidophil (experimental high dose) |
| 2 | Experimental | Not described Receives: Drug: Lacidophil (experimental standard dose) |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal.
Measured: 2 weeks
Secondary outcomes (7)
Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal.
Measured: 2 weeks
Intravenous rehydration
Measured: 2 weeks
Duration of diarrhea
Measured: Meaured by outcome
Duration of vomiting
Measured: Meaured by outcome
Number of days the child does not go to daycare.
Measured: Measured by outcome
Work absenteeism
Measured: 2 weeks
Economic analysis
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startApr 2009
- Primary completionSep 2013
- Study completionMar 2014
Why it stopped: Funding ended and fewer than required number of patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Freedman, The Hospital for Sick Children
- Investigators
- Stephen Freedman, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760773
- Sponsor's protocol ID
- 1000012686
- Status last verified
- Apr 2018
- First submitted
- 25 Sep 2008
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance: Randomized Controlled Trial and Economic Analysis
- ClinicalTrials.gov ID
- NCT00760773
- Acronym / sponsor ID
- 1000012686
- Conditions
- Gastroenteritis
- Keywords
- Probiotic treatment, Daycare attendance, Pediatric, Emergency department
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended and fewer than required number of patients enrolled.
- Enrolment
- 132 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Sep 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 objective of this study is to determine for previously healthy children, who present to an ED with acute gastroenteritis, if the probability of daycare absenteeism is significantly different in those who receive a probiotic agent compared to those who receive placebo.
Detailed description
Gastroenteritis in children utilizes significant health care resources and has a significant impact on children, caregivers and society. In the United States, gastroenteritis accounts for more than 1.5 million outpatient visits and 200,000 hospitalizations per year. Data from British Columbia indicate that gastroenteritis annually accounts for 12 million missed workdays by adults and 10 million missed school days by children in this province alone. Canadian data, including the cost of work absenteeism, report the mean annual cost/gastroenteritis case to be $1,089.
Although medications have not routinely been recommended, acute gastroenteritis in children can result in significant morbidity. Thus, physicians and caregivers desire treatment options to reduce the burden of disease. Recently, ondansetron, an antiemetic agent has been found to be effective in pediatric gastroenteritis, and is now frequently employed to reduce vomiting. Probiotics agents may represent another valuable treatment option. Since the early 1990s, research has been conducted on the effects of probiotics, defined as viable microbial preparations that have a beneficial effect on the health and well being of the host.
A recent Cochrane Database systematic review recently concluded that "probiotics appear to be a useful adjunct to rehydration therapy in treating acute, infectious diarrhea." However, the review also concluded that more research is needed to determine which specific probiotic regimens should be employed in specific patient groups. The later statement is of particular importance in North America as probiotics are not a mainstay of clinical practice. While only 18% of Canadian physicians are aware of research on probiotics, 82% feel that more probiotic research is needed, and 76% feel there is a role for probiotics in their practice. This discrepancy likely is due to the absence of probiotic trials in North American patients and because the outcome measures evaluated often have had limited clinical applicability. Since most episodes of acute diarrhea require no specific treatment, cost-effectiveness analyses are also required before the widespread use of probiotics can be endorsed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lacidophil (experimental high dose) |
| 2 | Experimental | Drug: Lacidophil (experimental standard dose) |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 4 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Acute gastroenteritis as determined by the supervising physician.
- Attend daycare
- Presence of diarrhea.
- Duration of vomiting or diarrhea less than 96 hours.
- Age greater than 90 days
Key exclusion criteria (11 listed)
- Presence of an indwelling vascular access line or congenital heart disease.
- Taking immunosuppressive therapy or history of immunodeficiency (including all primary, secondary and acquired states)
- Have recently had cardiac, oral or gastrointestinal surgery
- Pancreatic dysfunction or bloody diarrhea
- History of: hematochezia, underlying chronic gastrointestinal problem, short bowel syndrome or inflammatory bowel disease
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 |
|---|---|---|
| Lacidophil (experimental high dose)Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the high dose which will consist of 4 billion CFU (1 active sachet) PO BID (total daily dose = 8 billion CFU) x 5 days. | Drug | 1 |
| Lacidophil (experimental standard dose)Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the standard dose which will consist of 4 billion CFU (1 active sachet) PO QAM (total daily dose = 4 billion CFU) plus 1 placebo sachet PO QHS x 5 days. | Drug | 2 |
| PlaceboThe total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. | Drug | 3 |
Primary outcome
Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal.
Time frame: 2 weeks
7 secondary outcomes
Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal.
Time frame: 2 weeks
Intravenous rehydration
Time frame: 2 weeks
Duration of diarrhea
Time frame: Meaured by outcome
Duration of vomiting
Time frame: Meaured by outcome
Number of days the child does not go to daycare.
Time frame: Measured by outcome
Work absenteeism
Time frame: 2 weeks
Economic analysis
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Funding ended and fewer than required number of patients enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
Related trials for Gastroenteritis
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
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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.
Stephen Freedman, MD principal investigator
The Hospital for Sick Children
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lacidophil (experimental high dose) and Lacidophil (experimental standard dose) in people with Gastroenteritis, run by The Hospital for Sick Children at 3 sites 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 6 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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: Funding ended and fewer than required number of patients enrolled.). 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?
Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal. (time frame: 2 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 17 Apr 2018.