Trial record 9 of 685 for:    Open Studies | "Gastroenteritis"

Emergency Department Probiotic Treatment of Pediatric Gastroenteritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Calgary
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Alberta Children's Hospital
The Hospital for Sick Children
Children's Hospital of Eastern Ontario
St. Justine's Hospital
IWK Health Centre
Institut Rosell Lallemand
Information provided by (Responsible Party):
Sarah Williamson, University of Calgary
ClinicalTrials.gov Identifier:
NCT01853124
First received: May 9, 2013
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The objective of this study is to determine for previously healthy children who present to a Canadian Emergency Department (ED) with acute gastroenteritis (infection or irritation of the digestive tract); if compared with placebo, the administration of a probiotic agent (Lacidofil) will result in a significantly lower proportion of children developing moderate to severe disease over the subsequent 2 weeks and will not be associated with a significantly greater occurrence of side effects.


Condition Intervention Phase
Gastroenteritis
Drug: Placebo
Drug: Lacidofil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Development of moderate to severe disease in the 2 weeks after the index visit [ Time Frame: Measured daily for 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Diarrhea [ Time Frame: Daily for 14 days ] [ Designated as safety issue: No ]
  • Duration of Vomiting [ Time Frame: Daily for 14 days ] [ Designated as safety issue: No ]
  • Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal, within two weeks [ Time Frame: Daily for 14 days ] [ Designated as safety issue: No ]
  • Work and Daycare Absenteeism [ Time Frame: Daily for 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 886
Study Start Date: October 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacidofil
Lacidofil sachet containing active ingredients
Drug: Lacidofil
All patients in this arm of the study will take 1 sachet twice daily for 5 days. Each sachet will contain a minimum of 4 billion colony-forming units (CFU) of Lactobacillus rhamnosus Rosell-11 (95%) and L. helveticus Rosell-52 (5%). The total weight of all ingredients is 1 gm. 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. Total daily dose = 8 billion CFU x 5 days.
Placebo Comparator: Placebo
Placebo sachet containing inactive ingredients
Drug: Placebo
All patients in this arm of the study will take 1 sachet containing inactive ingredients (maltodextrin, magnesium stearate, and ascorbic acid) 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. Total of 2 sachets per day for 5 days.

Detailed Description:

The burden of acute gastroenteritis (AGE) on children and their families continues to be enormous. It accounts for 1.7 million pediatric emergency department (ED) visits annually in the United States and nearly 240,000 in Canada. Children often suffer from prolonged and severe illness; amongst hospitalized Canadian children, 19% have clinical sepsis, 7% seizures and 4% require intensive care unit admission.3 In a study that we conducted at 11 Canadian EDs, 51% of children experienced moderate to severe disease. Parents rate such episodes as being equivalent to a 10 day admission (moderate) and persistent moderate hearing loss (severe). The burden is augmented by the 50% household transmission rate2, 6 and 42% prolonged work absenteeism rate. Apart from supportive care, health-care providers have little to offer to relieve suffering.

Probiotics, which are defined as viable microbial preparations that have a beneficial effect on the health of the host, represent a rapidly expanding field. While they are available as over-the-counter products, according to the National Institutes of Health, the Food and Drug Administration has not yet approved a single agent for any health claims. Further, a 2012 meta-analysis concluded that there is limited data to support their indications and no published pediatric gastroenteritis trials reported on side effects. Thus, understanding the benefits and side effects of probiotics is crucial before widespread use can be endorsed. Although probiotic clinical trials have been performed, only one (still unpublished) has been ED based. Most studies to date have been significantly flawed and guidelines do NOT endorse their use stating that well-controlled human trials are needed. Consequently, we and others have found that they are rarely used in clinical practice. Reasons cited include (1) questionable clinical meaning to the outcomes evaluated thus far; (2) absence of studies in the appropriate patient population, and (3) a lack of confidence in the quality of probiotic agents studied.

This study will address (1) the needs of the medical community, which is aware of the widening gap between the number of important pediatric and adult trials and (2) the interest of caregivers in "probiotics" - 71% are aware of the term; 31% believe they may be beneficial in children with diarrhea, and > 90% would administer a probiotic if it could make their child better. Furthermore, our pilot study has provided promising preliminary data and has proven the feasibility of our methods. Thus we are poised to conduct a randomized controlled trial (RCT)that will definitively determine if meaningful benefits are derived from probiotic use and will provide critical information regarding their mechanism of action. This information will impact on practice, the burden of disease, and ensure that children receive the best care possible. The results of our proposed RCT will enable guidelines to either clearly endorse or recommend against the routine use of a probiotic agent in children with Acute Gastroenteritis.

  Eligibility

Ages Eligible for Study:   3 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of diarrhea: defined as ≥ 3 watery stools in a 24-hour period
  • Duration of vomiting or diarrhea < 72 hours
  • Age 3 to < 48 months

Exclusion Criteria:

  • Presence of an indwelling vascular access line or structural heart disease
  • Taking immunosuppressive therapy, or known history of immunodeficiency
  • Hematochezia in the preceding 72 hours, underlying significant chronic gastrointestinal problem or inflammatory bowel disease
  • Family member with an indwelling vascular access line, on immunosuppressive therapy, or with a known immunodeficiency
  • Bilious vomiting
  • Probiotic use (supplement) in the preceding 2 weeks
  • Previously enrolled in this trial
  • Daily follow-up not possible
  • Allergy to Soy
  • Pre-existing (known) pancreatic dysfunction or insufficiency
  • Oral or Gastrointestinal surgery within preceding 7 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853124

Contacts
Contact: Sarah Williamson, BScKIN (403)955-2482 sarah.williamson2@albertahealthservices.ca
Contact: Stephen Freedman, MD (403)955-7740 stephen.freedman@albertahealthservices.ca

Locations
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Sarah Williamson-Urquhart, BScKIN    (403)955-2482    sarah.urquhart@albertahealthservices.ca   
Contact: Janielee Williamson, RN    (403)955-3186    janie.williamson@albertahealthservices.ca   
Principal Investigator: Stephen Freedman, MD         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Eleanor Fitzpatrick, RN, MN    (902)470-6560    eleanor.fitzpatrick@iwk.nshealth.ca   
Contact: Jessica MacIntyre, MSc       jessica.macintyre@iwk.nshealth.ca   
Principal Investigator: Katrina Hurley, MD         
Sub-Investigator: Karen Black, MD         
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Dale Dalgleish, RN    (613) 737-7600 ext 3824    ddalgleish@cheo.on.ca   
Contact: Rhonda Correll    (613) 737-7600 ext 4153    correll@cheo.on.ca   
Principal Investigator: Ken Farion, MD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Judy Sweeney, RN    (416)813-7654 ext 207838    judy.sweeney@sickkids.ca   
Principal Investigator: Suzanne Schuh, MD         
Canada, Quebec
Centre Hospitalier Universitaire Sainte Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Marie-Christine Auclair, RN    (514) 345-4931 ext 3827    marie-christine.auclair@recherche-ste-justine.qc.ca   
Principal Investigator: Serge Gouin, MD         
Sponsors and Collaborators
Sarah Williamson
Canadian Institutes of Health Research (CIHR)
Alberta Children's Hospital
The Hospital for Sick Children
Children's Hospital of Eastern Ontario
St. Justine's Hospital
IWK Health Centre
Institut Rosell Lallemand
Investigators
Principal Investigator: Stephen Freedman, MD University of Calgary
  More Information

No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarah Williamson, Research Coordinator, University of Calgary
ClinicalTrials.gov Identifier: NCT01853124     History of Changes
Other Study ID Numbers: RSO102453
Study First Received: May 9, 2013
Last Updated: April 3, 2014
Health Authority: Canada: Health Canada
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014