NCT01853124

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
886

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2013

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

3.5 years

First QC Date

May 9, 2013

Last Update Submit

February 28, 2018

Conditions

Gastroenteritis

Keywords

Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Development of moderate to severe disease in the 2 weeks after the index visit

    Measured daily for 14 days

Secondary Outcomes (4)

  • Duration of Diarrhea

    Daily for 14 days

  • Duration of Vomiting

    Daily for 14 days

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

    Daily for 14 days

  • Work and Daycare Absenteeism

    Daily for 14 days

Other Outcomes (3)

  • Side Effect Profile

    Daily for 14 days

  • Mechanism of Action

    28 Days

  • Pathogen Load Quantification

    Determine if a 5-day probiotic treatment course administered to children with acute gastroenteritis results in pathogen-specific reductions in stool pathogen load

Study Arms (2)

Lacidofil

EXPERIMENTAL

Lacidofil sachet containing active ingredients

Drug: Lacidofil

Placebo

PLACEBO COMPARATOR

Placebo sachet containing inactive ingredients

Drug: Placebo

Interventions

PlaceboDRUG

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.

Placebo
LacidofilDRUG

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.

Lacidofil

Eligibility Criteria

Age3 Months - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Children's Hospital, London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Centre Hospitalier Universitaire Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (7)

  • Horne RG, Freedman SB, Johnson-Henry KC, Pang XL, Lee BE, Farion KJ, Gouin S, Schuh S, Poonai N, Hurley KF, Finkelstein Y, Xie J, Williamson-Urquhart S, Chui L, Rossi L, Surette MG, Sherman PM. Intestinal Microbial Composition of Children in a Randomized Controlled Trial of Probiotics to Treat Acute Gastroenteritis. Front Cell Infect Microbiol. 2022 Jun 14;12:883163. doi: 10.3389/fcimb.2022.883163. eCollection 2022.

    PMID: 35774405DERIVED

  • Freedman SB, Finkelstein Y, Pang XL, Chui L, Tarr PI, VanBuren JM, Olsen C, Lee BE, Hall-Moore CA, Sapien R, O'Connell K, Levine AC, Poonai N, Roskind C, Schuh S, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Hurley K, Powell EC, Farion KJ, Schnadower D. Pathogen-Specific Effects of Probiotics in Children With Acute Gastroenteritis Seeking Emergency Care: A Randomized Trial. Clin Infect Dis. 2022 Aug 24;75(1):55-64. doi: 10.1093/cid/ciab876.

    PMID: 34596225DERIVED

  • Freedman SB, Horne R, Johnson-Henry K, Xie J, Williamson-Urquhart S, Chui L, Pang XL, Lee B, Schuh S, Finkelstein Y, Gouin S, Farion KJ, Poonai N, Hurley K, Schnadower D, Sherman PM; Pediatric Emergency Research Canada Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment (PROGUT) Trial Group. Probiotic stool secretory immunoglobulin A modulation in children with gastroenteritis: a randomized clinical trial. Am J Clin Nutr. 2021 Apr 6;113(4):905-914. doi: 10.1093/ajcn/nqaa369.

    PMID: 34269370DERIVED

  • Freedman SB, Roskind CG, Schuh S, VanBuren JM, Norris JG, Tarr PI, Hurley K, Levine AC, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Powell EC, Farion KJ, Sapien R, O'Connell K, Poonai N, Schnadower D; Pediatric Emergency Research Canada and Pediatric Emergency Care Applied Research Networks. Comparing Pediatric Gastroenteritis Emergency Department Care in Canada and the United States. Pediatrics. 2021 Jun;147(6):e2020030890. doi: 10.1542/peds.2020-030890. Epub 2021 May 20.

    PMID: 34016656DERIVED

  • Poonai N, Powell EC, Schnadower D, Casper TC, Roskind CG, Olsen CS, Tarr PI, Mahajan P, Rogers AJ, Schuh S, Hurley KF, Gouin S, Vance C, Farion KJ, Sapien RE, O'Connell KJ, Levine AC, Bhatt S, Freedman SB; Pediatric Emergency Care Applied Research Network (PECARN) and Pediatric Emergency Research Canada (PERC). Variables Associated With Intravenous Rehydration and Hospitalization in Children With Acute Gastroenteritis: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 Apr 1;4(4):e216433. doi: 10.1001/jamanetworkopen.2021.6433.

    PMID: 33871616DERIVED

  • Freedman SB, Williamson-Urquhart S, Farion KJ, Gouin S, Willan AR, Poonai N, Hurley K, Sherman PM, Finkelstein Y, Lee BE, Pang XL, Chui L, Schnadower D, Xie J, Gorelick M, Schuh S; PERC PROGUT Trial Group. Multicenter Trial of a Combination Probiotic for Children with Gastroenteritis. N Engl J Med. 2018 Nov 22;379(21):2015-2026. doi: 10.1056/NEJMoa1802597.

    PMID: 30462939DERIVED

  • Freedman SB, Williamson-Urquhart S, Schuh S, Sherman PM, Farion KJ, Gouin S, Willan AR, Goeree R, Johnson DW, Black K, Schnadower D, Gorelick MH; Pediatric Emergency Research Canada (PERC) Gastroenteritis Study Group. Impact of emergency department probiotic treatment of pediatric gastroenteritis: study protocol for the PROGUT (Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment) randomized controlled trial. Trials. 2014 May 14;15:170. doi: 10.1186/1745-6215-15-170.

    PMID: 24885220DERIVED

MeSH Terms

Conditions

GastroenteritisDiarrhea

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen Freedman, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Pediatrics; Alberta Children's Hospital Foundation Professor in Child Health and Wellness Alberta Children's Hospital Theme Lead

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 14, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

CA(6)