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

Primary Purpose

Acute Gastroenteritis

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Lactobacillus reuteri DSM 17938
Placebo
Sponsored by
Szpital im. Św. Jadwigi Śląskiej
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gastroenteritis

Eligibility Criteria

2 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Szpiatal im.Świętej Jadwigi Śląskiej

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lactobacillus reuteri DSM 17938

Placebo

Arm Description

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 consists of an identical formulation, except active substance.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2016
Last Updated
January 28, 2019
Sponsor
Szpital im. Św. Jadwigi Śląskiej
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1. Study Identification

Unique Protocol Identification Number
NCT02989350
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szpital im. Św. Jadwigi Śląskiej

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus reuteri DSM 17938
Arm Type
Active Comparator
Arm Description
2 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo consists of an identical formulation, except active substance.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri DSM 17938
Intervention Description
Lactobacillus reuteri DSM 17938 vs Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Lactobacillus reuteri DSM 17938 vs Placebo
Primary Outcome Measure Information:
Title
Duration of diarrhea
Description
(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.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Need for intravenous rehydration
Description
Number of patients in each group requiring intravenous rehydration
Time Frame
8 days
Title
Duration of intravenous rehydration
Time Frame
8 days
Title
Need for hospitalisation of outpatients
Description
Number of patients enrolled as outpatient requiring hospitalisation - based on medical assesment
Time Frame
8 days
Title
Number of watery stools per day
Time Frame
8 days
Title
Vomiting
Description
Number of participants with vomits and number of vomits per day
Time Frame
8 days
Title
Recurrence of diarrhoea (in 48 hours after intervention)
Description
Number of patients in which diarrhoea recur after initial recovery in 48 hours
Time Frame
48 hours
Title
Severity of diarrhoea according to Vesikari scale
Time Frame
8 days
Title
Use of concomitant medications
Time Frame
8 days
Title
Adverse events
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Age: older than 1 month and younger than 60 months. A caregiver must provide written informed consent. Exclusion Criteria: Use of antibiotics within two weeks prior to enrolment. Use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment (a single dose is allowed). Breast feeding (>50%) Chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy) Immunodeficiency Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henryk Szymański, MD PhD
Organizational Affiliation
Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Szpiatal im.Świętej Jadwigi Śląskiej
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28835355
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.
Results Reference
derived
Links:
URL
http://www.researchprotocols.org/2017/8/e164/
Description
published protocol

Learn more about this trial

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

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