Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children

Overview

Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. According to the 2014 guidelines developed by the ESPGHAN probiotics may be considered in the management of children with AGE in addition to rehydration therapy. Considering that evidence on L reuteri remains limited, the investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately. Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.

Full Title of Study: “Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Randomised Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2018

Interventions

  • Dietary Supplement: Lactobacillus reuteri DSM 17938
    • Lactobacillus reuteri DSM 17938 vs Placebo
  • Dietary Supplement: Placebo
    • Lactobacillus reuteri DSM 17938 vs Placebo

Arms, Groups and Cohorts

  • Active Comparator: Lactobacillus reuteri DSM 17938
    • 2 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days.
  • Placebo Comparator: Placebo
    • Placebo consists of an identical formulation, except active substance.

Clinical Trial Outcome Measures

Primary Measures

  • Duration of diarrhea
    • Time Frame: 8 days
    • (measured in hours) – time until the normalisation of stool consistency according to the Bristol Stool Form Scale(BSF) or Amsterdam Infant Stool Scale (ASF) – (in BSF scale, numbers 1, 2, 3, 4 and 5; in ASF scale, letters B or C), or the time until the normalisation of the number of stools (compared with the period before the onset of diarrhoea).and the presence of normal stools for 48 h.

Secondary Measures

  • Need for intravenous rehydration
    • Time Frame: 8 days
    • Number of patients in each group requiring intravenous rehydration
  • Duration of intravenous rehydration
    • Time Frame: 8 days
  • Need for hospitalisation of outpatients
    • Time Frame: 8 days
    • Number of patients enrolled as outpatient requiring hospitalisation – based on medical assesment
  • Number of watery stools per day
    • Time Frame: 8 days
  • Vomiting
    • Time Frame: 8 days
    • Number of participants with vomits and number of vomits per day
  • Recurrence of diarrhoea (in 48 hours after intervention)
    • Time Frame: 48 hours
    • Number of patients in which diarrhoea recur after initial recovery in 48 hours
  • Severity of diarrhoea according to Vesikari scale
    • Time Frame: 8 days
  • Use of concomitant medications
    • Time Frame: 8 days
  • Adverse events
    • Time Frame: 8 days

Participating in This Clinical Trial

Inclusion Criteria

1. Acute gastroenteritis (AGE) defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale or in the case of infants, the Amsterdam Stool Form (ASF) scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days. 2. Age: older than 1 month and younger than 60 months. 3. A caregiver must provide written informed consent. Exclusion Criteria:

1. Use of antibiotics within two weeks prior to enrolment. 2. Use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment (a single dose is allowed). 3. Breast feeding (>50%) 4. Chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy) 5. Immunodeficiency 6. Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)

Gender Eligibility: All

Minimum Age: 2 Months

Maximum Age: 60 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Szpital im. Św. Jadwigi Śląskiej
  • Provider of Information About this Clinical Study
    • Principal Investigator: Henryk Szymański, MD PhD – Szpital im. Św. Jadwigi Śląskiej
  • Overall Official(s)
    • Henryk Szymański, MD PhD, Principal Investigator, Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland

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