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Randomised clinical trial: the synbiotic food supplement Probiotical vs. placebo for acute gastroenteritis in children.
Plain-language guide to PMID 21899583 (2011): double-blind randomized controlled trial in 111 children.
Key Facts
- PMID
- 21899583
- Journal
- Alimentary pharmacology & therapeutics
- Year
- 2011
- Study type
- Randomized Controlled Trial
- Authors
- Vandenplas Y et al. (2 authors)
- DOI
- 10.1111/j.1365-2036.2011.04835.x
What This Study Did, in Plain Language
What Was Tested
Researchers studied the intervention named in the title in this randomized controlled trial publication.
The primary end-points were duration of diarrhoea and the number of children that had a normalised stool consistency.
Why It Was Studied
As a result of strain and product specificity, each product needs support by clinical data.
Who Took Part
According to the abstract, 111 children were involved.
PubMed indexes the participants as infants, young children, children and teenagers, both men and women.
A total of 111 children with acute diarrhoea (median age 40 months) were included in this randomised, prospective placebo-controlled parallel clinical trial in primary health care.
All children were treated with oral rehydration solution ad libitum and with the synbiotic (n=57) or placebo (n = 54).
How the Study Was Run
In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.
Because people in this study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Neither the children nor the staff measuring them knew who was on the intervention named in the title, so expectations could not easily colour the readings.
A placebo (an inactive look-alike) gave the intervention group a baseline to be compared against.
The intervention group and the comparison group ran side by side rather than switching.
What Was Measured
PubMed files the paper under topics including Belgium, Diarrhea, Feces, Gastroenteritis and Synbiotics.
What This Means in Plain Language
The paper is a randomized, double-blind and placebo-controlled study in 111 children.
Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.
The publication is from 2011 (Alimentary pharmacology & therapeutics), a journal based in England.
More context: all human trials.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.