Clinical trial NCT02989350: Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children
Official title: Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Gastroenteritis
Lead sponsor: Szpital im. Św. Jadwigi Śląskiej
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Duration of diarrhea
timeFrame: 8 days
Secondary outcomes:
measure: Need for intravenous rehydration
timeFrame: 8 days
measure: Duration of intravenous rehydration
timeFrame: 8 days
measure: Need for hospitalisation of outpatients
timeFrame: 8 days
measure: Number of watery stools per day
timeFrame: 8 days
measure: Vomiting
timeFrame: 8 days
measure: Recurrence of diarrhoea (in 48 hours after intervention)
timeFrame: 48 hours
measure: Severity of diarrhoea according to Vesikari scale
timeFrame: 8 days
measure: Use of concomitant medications
timeFrame: 8 days
measure: Adverse events
timeFrame: 8 days
Other outcomes:
Locations:
city: Trzebnica
country: Poland
facility: Szpiatal im.Świętej Jadwigi Śląskiej
Study officials:
affiliation: Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland
name: Henryk Szymański, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szymanski H, Szajewska H. Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Aug 23;6(8):e164. doi: 10.2196/resprot.7924.