Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance

NCT00760773 | Terminated Phase 2 DMC

• 1 other identifier: 1000012686
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gastroenteritis

Keywords

Probiotic treatment; Daycare attendance; Pediatric; Emergency department

Outcome Measures

Primary Outcomes (1)

• Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal.

  2 weeks

Secondary Outcomes (7)

• Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal.

  2 weeks

• Intravenous rehydration

  2 weeks

• Duration of diarrhea

  Meaured by outcome

• Duration of vomiting

  Meaured by outcome

• Number of days the child does not go to daycare.

  Measured by outcome

Study Arms (3)

1

EXPERIMENTAL

Drug: Lacidophil (experimental high dose)

2

EXPERIMENTAL

Drug: Lacidophil (experimental standard dose)

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

1

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.

2

Placebo DRUG

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.

3

Eligibility Criteria

• Age: 4 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Undergoing radiation therapy
• Exclusively breastfed
• Bilious or bloody vomitus
• Previously enrolled in this trial
• Inability to speak or read English

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (3)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Hospital Sainte Justine

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Gastroenteritis; Emergencies

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Freedman, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Scientist

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: April 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CA (3)