Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01737086
Study type Interventional
Source Umeå University
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date December 2012
Completion date February 2014

See also
  Status Clinical Trial Phase
Completed NCT04682860 - Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide Phase 4
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Completed NCT01577043 - Efficacy of Racecadotril in Acute Watery Diarrhea in Children Phase 4
Completed NCT03234777 - Evaluating a Knowledge Translation Tool for Parents N/A
Not yet recruiting NCT02619201 - Antiemetic Efficacy of Ondansetron Versus Metoclopramide Phase 3
Completed NCT02280759 - Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children. Phase 1
Completed NCT06090708 - Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis N/A
Recruiting NCT05270291 - Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis
Completed NCT02025452 - Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis Phase 4
Not yet recruiting NCT06038305 - Prevalence of Anemia and Growth Assessment in Acute Gastroenteritis
Completed NCT02803827 - Optimizing the Management of Acute Diarrhoeal Disease Phase 3
Completed NCT02644200 - Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis Phase 3
Completed NCT02174874 - Ondansetron Oral Versus Orally Disintegrating Tablets (ODT) N/A
Completed NCT03539913 - Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children Phase 4
Recruiting NCT06137014 - Fortified Oral Rehydration Therapy for Pediatric Diarrhea Phase 1/Phase 2
Completed NCT04463355 - Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department N/A
Completed NCT04555200 - Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis
Completed NCT02169817 - Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children Phase 4
Unknown status NCT02177799 - Surveillance Study of Acute Gastroenteritis in Hospitalized Children in Rural Area in Lebanon N/A
Completed NCT01886755 - Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis N/A