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DiarrheaPhase 4NCT01657032

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

A Phase 4 study testing Smectite and Lactobacillus GG in people with Diarrhea, run by Medical University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 3 months to 5 years
Conditions the study is for
Diarrhea
What is being tested?
Smectite and Lactobacillus GG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 sitePoland
Study dates
Aug 2010to Oct 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Department of Paediatrics, The Medical University of Warsaw

    Warsaw, Warsaw, 01-183

Other trials in Poland

About this study

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

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).

Read the detailed description

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.

Conditions
Diarrhea
Being tested
Smectite, Placebo, Lactobacillus GG
Keywords
diarrhea, probiotics, diosmectite
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmectiteDietary supplement

    Also called Smecta

    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.

  • PlaceboDietary supplement

    Also called glucose

    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.

  • Lactobacillus GGDietary supplement

    Also called Dicoflor 30

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

Study groups in NCT01657032
Study groupRoleWhat they receive
Lactobacillus GG and SmectiteExperimentalChildren received: * LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and * smectite, dose 3 g, once daily orally until diarrhea stopped
Receives: Dietary Supplement: Smectite; Dietary Supplement: Lactobacillus GG
Lactobacillus GG and PlaceboPlacebo comparatorChildren received: * LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and * placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Receives: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus GG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Diarrhea

    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).

    Measured: counted in days during 7days

Secondary outcomes (10)

  1. Frequency of Loose Stools,

    number of loose stools during 7 days

    Measured: number of loose stools during 7 days

  2. Consistency of Stools

    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.

    Measured: day 4-th

  3. Need for Antibiotic Therapy,

    need for antibiotic therapy because of diarrhea

    Measured: yes/no, for 7days

  4. Vomiting

    If the child vomiting after randomization (yes/no)

    Measured: yes/no, for 7days

  5. Vomiting

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

    Measured: how many times for 7days

  6. Diarrhea Recurrence

    If the was a diarrhea recurrence during 7days

    Measured: 7 days

  7. Tolerance of Products

    tolerance of products (whether the child took medicaments),

    Measured: 7days

  8. Need for Hospitalization

    If the child need to hospitalized

    Measured: 7 days

  9. Need for Intravenous Therapy

    need for intravenous rehydration therapy (yes/no)

    Measured: yes/no, for 7days

  10. Duration of Intravenous Therapy

    need for intravenous rehydration therapy (how long if needed)

    Measured: 7days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2012 (estimated)
  2. Study startAug 2010
  3. Primary completionSep 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01657032
Sponsor's protocol ID
KB2010
Status last verified
Jan 2010
First submitted
5 Jul 2012
Last updated
1 Apr 2014
Data monitoring committee
Yes

Publications

  • Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, Szajewska H; ESPGHAN/ESPID Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe Expert Working Group. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: executive summary. J Pediatr Gastroenterol Nutr. 2008 May;46(5):619-21. doi: 10.1097/MPG.0b013e31816e219e. No abstract available.

    PubMed 18493225

  • Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. doi: 10.1016/s0168-1605(97)00136-0. No abstract available.

    PubMed 9553803

  • Szajewska H, Skorka A, Ruszczynski M, Gieruszczak-Bialek D. Meta-analysis: Lactobacillus GG for treating acute diarrhoea in children. Aliment Pharmacol Ther. 2007 Apr 15;25(8):871-81. doi: 10.1111/j.1365-2036.2007.03282.x.

    PubMed 17402990

  • Szajewska H, Dziechciarz P, Mrukowicz J. Meta-analysis: Smectite in the treatment of acute infectious diarrhoea in children. Aliment Pharmacol Ther. 2006 Jan 15;23(2):217-27. doi: 10.1111/j.1365-2036.2006.02760.x.

    PubMed 16393300

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Smectite and Lactobacillus GG in people with Diarrhea, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Diarrhea (time frame: counted in days during 7days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01657032, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.

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