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Completed

NCT Number: NCT02989350

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

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.

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Key information

Conditions

Acute Gastroenteritis

Age range

2 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Szpiatal im.Świętej Jadwigi Śląskiej

Trzebnica, 55-100, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lactobacillus reuteri DSM 17938

Dietary Supplement

Lactobacillus reuteri DSM 17938 vs Placebo

Placebo

Dietary Supplement

Lactobacillus reuteri DSM 17938 vs Placebo

Primary outcomes

  1. Duration of diarrhea

    Time frame: 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 outcomes

  1. Need for intravenous rehydration

    Time frame: 8 days

    Number of patients in each group requiring intravenous rehydration

  2. Duration of intravenous rehydration

    Time frame: 8 days

  3. Need for hospitalisation of outpatients

    Time frame: 8 days

    Number of patients enrolled as outpatient requiring hospitalisation - based on medical assesment

  4. Number of watery stools per day

    Time frame: 8 days

  5. Vomiting

    Time frame: 8 days

    Number of participants with vomits and number of vomits per day

  6. Recurrence of diarrhoea (in 48 hours after intervention)

    Time frame: 48 hours

    Number of patients in which diarrhoea recur after initial recovery in 48 hours

  7. Severity of diarrhoea according to Vesikari scale

    Time frame: 8 days

  8. Use of concomitant medications

    Time frame: 8 days

  9. Adverse events

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Szpital im. Św. Jadwigi Śląskiej

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 12, 2016
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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