Randomised Clinical Trial: Lactobacillus reuteri DSM 17938 vs. Placebo in Children With Acute Diarro...
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Aliment Pharmacol Ther 2012:36 (4):363-369 R. Francavilla et al 16 th July 2013 Shamshad Shah - PowerPoint PPT Presentation


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Randomised Clinical Trial: Lactobacillus reuteri DSM 17938 vs. Placebo in Children With Acute Diarrohea. Aliment Pharmacol Ther 2012:36 (4):363-369 R. Francavilla et al 16 th July 2013 Shamshad Shah. Question.

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Randomised Clinical Trial: Lactobacillus reuteri DSM 17938 vs. Placebo in Children With Acute Diarrohea

Aliment Pharmacol Ther 2012:36 (4):363-369

R. Francavilla et al

16th July 2013

Shamshad Shah


Question
Question vs. Placebo in Children With Acute Diarrohea

Is there clinical evidence supporting the therapeutic effects of probiotics in children with acute diarrhoea?


Background
Background vs. Placebo in Children With Acute Diarrohea

  • Viewed from a global perspective gastroenteritis in children is of great public health importance

  • The use of ORT contributed to a marked reduction in death rates globally

  • In developed countries 30% hospital admissions for gastroenteritis due to rotavirus

  • Probiotics are live micro organisms which when administered in adequate amounts confer a health benefit to the host

  • Cochrane review; 56 trials concluded specific probiotics reduce duration diarrhoea 24 hours and frequency stools


Literature search
Literature Search vs. Placebo in Children With Acute Diarrohea

[clinical trial]

AND [diarrhoea]

AND [probiotics]

AND [children].

Limited to [child 0 – 36 months AND English language]


Aim of study
Aim of Study vs. Placebo in Children With Acute Diarrohea

To test the efficacy and safety of a new strain Lactobacillus reuteri DSM 17938 derived from L reuteri ATCC 55730 in children with acute diarrhoea

Primary outcomes were the rate of unresolved diarrhoea after 3 days of treatment and duration of diarrhoea.

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Method
Method vs. Placebo in Children With Acute Diarrohea

Children 6 – 36 months old were recruited from 3 wards across 3 hospitals in S Italy from Jan –July 2009

Diagnosed with acute diarrhoea with clinical signs dehydration

Randomised to receive in a double blind fashion either L reuteri or a placebo

Symptoms were recorded in a diary 1 week


Method1
Method vs. Placebo in Children With Acute Diarrohea

Inclusion Criteria

  • Children 6-36 months old hospitalised with acute diarrhoea

  • Clinical signs of mild to moderate dehydration

  • No clinical features of hypovolaemic shock

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Method2
Method vs. Placebo in Children With Acute Diarrohea

Exclusion criteria

  • Included underlying chronic disease

  • Bloody stools at first examination

  • Current use of probiotic/antibiotics

  • Demonstration of bacterial cause for diarrhoea

  • Use of parenteral rehydration.

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Method3
Method vs. Placebo in Children With Acute Diarrohea

Approved by ethics committee

Randomly assigned to receive either L reuteri or placebo

All enrolled children were entered sequentially to receive the assigned treatment

First dose was given immediately after informed consent

The study preparation was administered for 7 days

At start of treatment stool sample to test for rotavirus /adenovirus was collected

Dehydration was corrected in line with WHO recommendations

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Method4
Method vs. Placebo in Children With Acute Diarrohea

The active L reuteri and placebo preparation were based in mixture of sunflower oil and MCT

Both mixtures were presented in same shaped bottles

Dose 5 drops bd administered by nurse

Study was blinded for investigators and patients

Group assignments were concealed from participants and investigators

Codes were revealed after the study

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Outcome measures
Outcome Measures vs. Placebo in Children With Acute Diarrohea

Primary Outcomes

  • The rate of unresolved diarrhoea after 3 days treatment

  • Duration of diarrhoea

    Secondary outcomes

  • Duration of hospitalisation

  • Total intake of oral rehydration solution


Statistics
Statistics vs. Placebo in Children With Acute Diarrohea

Calculated a sample of 34 children per group required for study to have 80% power with a type 1 error =0.05 (two tailed test)

Assumption is based on similar trials (references not quoted)

SPSS

Variables were tested for normal distribution and compared using Mann-Whitney U test

Intention to treat analysis was performed

Statistical significance accepted at p<0.05

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Results
Results vs. Placebo in Children With Acute Diarrohea

96 children enrolled

Out of 64 children

10 children prompt recovery

43 children identified with rotavirus

10 children identified with adenovirus

11 children – no aetiology found

Baseline characteristics similar in both groups

L reuteri significantly reduced the duration of watery diarrhoea compared with placebo p<0.03

Effect of L reuteri mostly seen day 2 or 3 of treatment

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Enrolled assigned intervention and follow up
Enrolled Assigned Intervention and Follow up vs. Placebo in Children With Acute Diarrohea


Patients with persisting watery diarrhoea in the groups receiving placebo grey and l reuteri white
% patients with persisting watery diarrhoea in the groups vs. Placebo in Children With Acute Diarroheareceiving placebo (grey) andL reuteri (white)


Conclusion
Conclusion vs. Placebo in Children With Acute Diarrohea

L reuteri is efficaceous and safe alongside rehydration therapy shortening the duration and reducing stool frequency in acute infectious diarrhoea in young children

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Casp rct appraisal tool
CASP RCT Appraisal Tool vs. Placebo in Children With Acute Diarrohea

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Are the results of the trial valid
Are the results of the trial valid? vs. Placebo in Children With Acute Diarrohea


Clinical question
Clinical Question vs. Placebo in Children With Acute Diarrohea


Detailed questions
Detailed Questions vs. Placebo in Children With Acute Diarrohea


What are the results
What are the Results? vs. Placebo in Children With Acute Diarrohea


Will the results help locally
Will the results help locally? vs. Placebo in Children With Acute Diarrohea


Discussion
Discussion vs. Placebo in Children With Acute Diarrohea

  • Results relevant to Biogaia .Conflict of Interest ?

  • Small sample size but strong power 80% and no confidence intervals quoted – reliable recommendation to change practice in hospital setting?

  • If used in primary care setting would it reduce hospital admissions and costs?

  • Would a shorter duration of diarrhoea episode prevent secondary lactose intolerance?

  • Subgroups needed 6-12 months & 13-36 months?

  • Unable to compare results with other studies (probiotics species specific in each study)


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