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

Not Applicable

Completed

• Conditions: Acute Gastroenteritis
• Interventions: Dietary Supplement: Lactobacillus reuteri DSM 17938; Dietary Supplement: Placebo

• Registration Number: NCT02989350
• Lead Sponsor: Szpital im. Św. Jadwigi Śląskiej

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-12
• Study Start: 2017-01-16
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus reuteri DSM 17938	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	Placebo	Placebo consists of an identical formulation, except active substance.

Primary Outcome Measures

Name	Time	Method
Duration of diarrhea	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 Outcome Measures

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

Trial Locations

Locations (1)

Szpiatal im.Świętej Jadwigi Śląskiej; 🇵🇱 Trzebnica, Poland