NCT02989350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 16, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

December 1, 2016

Last Update Submit

January 28, 2019

Conditions

Acute Gastroenteritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Need for intravenous rehydration

    8 days

  • Duration of intravenous rehydration

    8 days

  • Need for hospitalisation of outpatients

    8 days

  • Number of watery stools per day

    8 days

  • Vomiting

    8 days

  • +4 more secondary outcomes

Study Arms (2)

Lactobacillus reuteri DSM 17938

ACTIVE COMPARATOR

2 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days.

Dietary Supplement: Lactobacillus reuteri DSM 17938

Placebo

PLACEBO COMPARATOR

Placebo consists of an identical formulation, except active substance.

Dietary Supplement: Placebo

Interventions

Lactobacillus reuteri DSM 17938DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938 vs Placebo

Lactobacillus reuteri DSM 17938
PlaceboDIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938 vs Placebo

Placebo

Eligibility Criteria

Age2 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Szpiatal im.Świętej Jadwigi Śląskiej

Trzebnica, 55-100, Poland

Location

Related Publications (1)

  • 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.

    PMID: 28835355DERIVED

Related Links

Study Officials

  • Henryk Szymański, MD PhD

    Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 12, 2016

Study Start

January 16, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

PL(1)