Skip to main content
OpenTrials
Completed

NCT Number: NCT01657032

Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis

Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Paediatrics, The Medical University of Warsaw

Warsaw, 01-183, Poland

About this study

ESPGHAN agreed to use probiotics, with proven efficacy, and smectite in treatment of AGE as an adjunct to standard rehydration therapy. Among probiotics Lactobacillus GG were found to be beneficial in meta-analyses. Treatment with LGG was associated with a significant reduction in diarrhea duration.

A recent review systematically evaluated the efficacy of smectite in treating acute infections diarrhea in infants and children.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children < 5 years old
  • diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
  • inform consent sing

Exclusion criteria

  • diarrhea < 1 or > 5 days,
  • a recent history of diarrhea indicated either by parents/guardian or hospital case notes,
  • underlying chronic gastrointestinal disease,
  • undernutrition (weight/height ratio below the 5th percentile),
  • systematic infection,
  • immune defects or immunosuppressive treatment

Treatment and study plan

Smectite

Dietary Supplement

Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.

Other names: Smecta

Placebo

Dietary Supplement

Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.

Other names: glucose

Lactobacillus GG

Dietary Supplement

All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite

Other names: Dicoflor 30

Primary outcomes

  1. Duration of Diarrhea

    Time frame: counted in days during 7days

    The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).

Secondary outcomes

  1. Frequency of Loose Stools,

    Time frame: number of loose stools during 7 days

    number of loose stools during 7 days

  2. Consistency of Stools

    Time frame: day 4-th

    consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories.

    Type 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1-2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea.

  3. Need for Antibiotic Therapy,

    Time frame: yes/no, for 7days

    need for antibiotic therapy because of diarrhea

  4. Vomiting

    Time frame: yes/no, for 7days

    If the child vomiting after randomization (yes/no)

  5. Vomiting

    Time frame: how many times for 7days

    How many times the child was vomiting (during the study)

  6. Diarrhea Recurrence

    Time frame: 7 days

    If the was a diarrhea recurrence during 7days

  7. Tolerance of Products

    Time frame: 7days

    tolerance of products (whether the child took medicaments),

  8. Need for Hospitalization

    Time frame: 7 days

    If the child need to hospitalized

  9. Need for Intravenous Therapy

    Time frame: yes/no, for 7days

    need for intravenous rehydration therapy (yes/no)

  10. Duration of Intravenous Therapy

    Time frame: 7days

    need for intravenous rehydration therapy (how long if needed)

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis: A Double Blind Randomized, Placebo- Controlled Trial

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 3, 2012
Registry last updated
Apr 1, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.