Comparing the Efficacy of Two Oral Rehydration Solutions, With or Without the Probiotic Lactobacillus Reuteri DSM 17938 and Zinc, on the Duration and Severity of Acute Gastroenteritis in 6 - 36 Months Old Children in Out-patient Care (Profat)

This study has been terminated.
(Terminated due to lack of eligible patients.)
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Torbjörn Lind, Umeå University
ClinicalTrials.gov Identifier:
NCT01737086
First received: November 26, 2012
Last updated: May 6, 2014
Last verified: February 2014
  Purpose

Oral rehydration solution (ORS) is recommended for treatment and prevention of dehydration due to acute gastroenteritis in infants and children. Acute diarrhoea leads to zinc depletion in infants, and zinc is recommended by the World Health Organization in the treatment of acute gastroenteritis in infants and children. However, the efficacy of zinc supplementation to children with acute gastroenteritis in more affluent settings is unclear. Selected strains of probiotics, including L. reuteri ATCC 55730, have been shown in several studies to shorten the duration of diarrhoea by about 24 hours, and also to attenuate symptom severity. If probiotics are given within 60 hours from onset of symptoms the duration can be reduced even more. Lactobacillus reuteri (L. reuteri) has been shown to reduce the duration and severity of acute gastroenteritis in children aged 6-36 months. In these studies L. reuteri was proven to have clinical effect on diarrhoea of both bacterial and viral (rotavirus) origin. In humans, L. reuteri strain DSM 17938 has recently been shown to reduce the duration of watery diarrhoea by 1.2 days among 6-36 mo old Italian children with acute gastroenteritis treated in hospital.

The present, community-based study aims to assess if an ORS with Lactobacillus reuteri DSM 17938 and zinc can be superior or equivalent to ORS without probiotic and zinc in reducing the duration of acute gastroenteritis in children aged 6-36 months, with no, mild or moderate dehydration when introduced early (within 48 hours) after the start of gastroenteritis associated diarrhoea in an out-patient setting.

A prospective, randomized, double blind, controlled study with parallel groups will be performed. Assuming a difference of 25% between groups in the primary outcome of prevalence of diarrhoea 48 hours after start of treatment (80% power, alfa = 5%), and estimating an attrition rate of approximately 15%, the final sample size will be 142 subjects, or 71 subjects in each arm.

Parents contacting the health care telephone enquiry agency, the primary care emergency unit, the paediatric emergency unit, all at the Umeå University Hospital or the well-baby care centres (BVC) in Umeå for advice on their children's gastroenteritis will be informed that they may participate in the present study and they will be given contact information to the research nurse for this activity. A home visit by study personnel will then be done for evaluation of eligibility, information, collection of informed consent and delivery of study product.

Data collection points will be at the recruitment visit in the patient's home, and by telephone on day 7. If the child still has gastrointestinal symptoms on day 5 it will be referred to the primary health care facility or the outpatient clinic of the Department of Paediatrics, Umeå University Hospital.


Condition Intervention Phase
Acute Gastroenteritis
Dietary Supplement: Lactobacillus reuteri DSM 17938 and zinc sulphate
Dietary Supplement: placebo
Phase 2
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: Comparing the Efficacy of Two Oral Rehydration Solutions, With or Without the Probiotic Lactobacillus Reuteri DSM 17938 and Zinc, on the Duration and Severity of Acute Gastroenteritis in 6 - 36 Months Old Children in Out-patient Care

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Proportion of children with loose or watery diarrhoea at 48 hours after start of treatment [ Time Frame: 48 h after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of diarrhoea [ Time Frame: 120 hours after start of treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Proportion of children with loose or watery diarrhoea per 24 hour period up to 120 hours after start of ORS treatment. [ Time Frame: 120 hours after start of treatment ] [ Designated as safety issue: No ]
  • Number of loose or watery stools per 24 hour period up to 120 hours after start of ORS treatment. [ Time Frame: 120 hours after start of treatment ] [ Designated as safety issue: No ]
  • Number of vomiting episodes per 24 hour period up to 120 hours af¬ter start of ORS treatment. [ Time Frame: 120 hours after start of treatment ] [ Designated as safety issue: No ]
  • ORS intake during first 24h [ Time Frame: 24 hours after start of treatment ] [ Designated as safety issue: No ]
  • Workdays' absence for parents [ Time Frame: 7 days after start of treatment ] [ Designated as safety issue: No ]
  • Daycare absence for the child [ Time Frame: 7 days after start of treatment ] [ Designated as safety issue: No ]
  • Need of hospitalisation [ Time Frame: 7 days after start of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 142
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORS with probiotic and zinc
Oral rehydration solution with freeze-dried Lactobacillus reuteri DSM 17938 and zinc sulphate
Dietary Supplement: Lactobacillus reuteri DSM 17938 and zinc sulphate
Placebo Comparator: Standard ORS
Standard oral rehydration solution
Dietary Supplement: placebo

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 - 36 months of age
  • 3 or more loose or watery stools during the past 24 hours
  • Available throughout the study period
  • Parents or legal guardians are able to give written informed consent to participation in the study.

Exclusion Criteria:

  • Diarrhoea with a duration of >48 hours at the time of recruitment.
  • Clinical signs of severe dehydration at the time of recruitment or in need of hospitalisation.
  • Clinical signs of a coexisting severe acute systemic illness (meningitis, sepsis, pneumonia).
  • Primary or secondary immunodeficiency.
  • Severe chronic diseases including cystic fibrosis, diabetes mellitus, neurodevelopmental delay or severe gastrointestinal disorders.
  • Use of probiotics in the previous 2 weeks before recruitment.
  • Use of antibiotics in the previous 2 weeks before recruitment.
  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: NCT01737086

Locations
Sweden
Pediatrics, Department of Clinical Sciences, Umeå University
Umeå, Västerbotten, Sweden, 90187
Sponsors and Collaborators
Umeå University
BioGaia AB
Investigators
Principal Investigator: Torbjörn Lind, M.D., Ph.D. Umeå University
  More Information

No publications provided

Responsible Party: Torbjörn Lind, Associate professor, Umeå University
ClinicalTrials.gov Identifier: NCT01737086     History of Changes
Other Study ID Numbers: Profat
Study First Received: November 26, 2012
Last Updated: May 6, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pharmaceutical Solutions
Zinc
Zinc Sulfate
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 01, 2014