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

Acute Gastroenteritis Clinical Trial

Official title:

Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989350
• Other study ID #: 1/2016
• Status: Completed
• Phase: N/A
• Start date: January 16, 2017
• Est. completion date: November 2018

Study information

• Verified date: January 2019
• Source: Szpital im. Sw. Jadwigi Slaskiej
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 60 Months

Eligibility

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)

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

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

Locations

Country	Name	City	State
Poland	Szpiatal im.Swietej Jadwigi Slaskiej	Trzebnica

Sponsors (1)

Lead Sponsor	Collaborator
Szpital im. Sw. Jadwigi Slaskiej

Country where clinical trial is conducted

Poland, 

Outcome

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

External Links

•   published protocol