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Randomised clinical trial : the synbiotic food supplement probiotical vs placebo for acute gastroenteritis in children

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Abstract
Background : Some probiotic strains reduce the duration of acute diarrhoea. As a result of strain and product specificity, each product needs support by clinical data. Aim : In children with acute diarrhoea, to test the efficacy of the synbiotic food supplement Probiotical (Streptoccoccus thermophilus, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium infantis, fructo-oligosaccharides). The primary end-points were duration of diarrhoea and the number of children that had a normalised stool consistency. Method : 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). Results : The median duration of diarrhoea was 3 days (IQ 25-75: 2-4 days) in the Probiotical group, compared with 4 days (IQ 25-75: 4-5 days) in the placebo group (P < 0.005). The number of children with normal stool consistency (defined as stool Bristol score <= 4) was higher in the synbiotic group on days 2 and 3 [21 vs. 2% (P < 0.001) and 50 vs. 24% (P < 0.001) respectively]. Less additional medication (antipyretics, antiemetics, antibiotics) was administered in the synbiotic group. Physicians were globally more satisfied with the synbiotic food supplement treatment than with placebo (P = 0.005). One patient in the placebo group was hospitalised. Conclusion : The median duration of diarrhoea was significantly 1 day shorter in the synbiotic than in the placebo group, associated with decreased prescription of additional medications.
Keywords
SACCHAROMYCES-BOULARDII, ACUTE DIARRHEA, ROTAVIRUS, METAANALYSIS, PREVENTION, LACTOBACILLUS, INFANTS

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Citation

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Chicago
Vandenplas, Y, and Stefan De Hert. 2011. “Randomised Clinical Trial : the Synbiotic Food Supplement Probiotical Vs Placebo for Acute Gastroenteritis in Children.” Alimentary Pharmacology & Therapeutics 34 (8): 862–867.
APA
Vandenplas, Y, & De Hert, S. (2011). Randomised clinical trial : the synbiotic food supplement probiotical vs placebo for acute gastroenteritis in children. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 34(8), 862–867.
Vancouver
1.
Vandenplas Y, De Hert S. Randomised clinical trial : the synbiotic food supplement probiotical vs placebo for acute gastroenteritis in children. ALIMENTARY PHARMACOLOGY & THERAPEUTICS. 2011;34(8):862–7.
MLA
Vandenplas, Y, and Stefan De Hert. “Randomised Clinical Trial : the Synbiotic Food Supplement Probiotical Vs Placebo for Acute Gastroenteritis in Children.” ALIMENTARY PHARMACOLOGY & THERAPEUTICS 34.8 (2011): 862–867. Print.
@article{1909200,
  abstract     = {Background : Some probiotic strains reduce the duration of acute diarrhoea. As a result of strain and product specificity, each product needs support by clinical data. 
Aim : In children with acute diarrhoea, to test the efficacy of the synbiotic food supplement Probiotical (Streptoccoccus thermophilus, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium infantis, fructo-oligosaccharides). The primary end-points were duration of diarrhoea and the number of children that had a normalised stool consistency. 
Method : 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). 
Results : The median duration of diarrhoea was 3 days (IQ 25-75: 2-4 days) in the Probiotical group, compared with 4 days (IQ 25-75: 4-5 days) in the placebo group (P {\textlangle} 0.005). The number of children with normal stool consistency (defined as stool Bristol score {\textlangle}= 4) was higher in the synbiotic group on days 2 and 3 [21 vs. 2\% (P {\textlangle} 0.001) and 50 vs. 24\% (P {\textlangle} 0.001) respectively]. Less additional medication (antipyretics, antiemetics, antibiotics) was administered in the synbiotic group. Physicians were globally more satisfied with the synbiotic food supplement treatment than with placebo (P = 0.005). One patient in the placebo group was hospitalised. 
Conclusion : The median duration of diarrhoea was significantly 1 day shorter in the synbiotic than in the placebo group, associated with decreased prescription of additional medications.},
  author       = {Vandenplas, Y and De Hert, Stefan},
  issn         = {1365-2036},
  journal      = {ALIMENTARY PHARMACOLOGY \& THERAPEUTICS},
  keyword      = {SACCHAROMYCES-BOULARDII,ACUTE DIARRHEA,ROTAVIRUS,METAANALYSIS,PREVENTION,LACTOBACILLUS,INFANTS},
  language     = {eng},
  number       = {8},
  pages        = {862--867},
  title        = {Randomised clinical trial : the synbiotic food supplement probiotical vs placebo for acute gastroenteritis in children},
  url          = {http://dx.doi.org/10.1111/j.1365-2036.2011.04835},
  volume       = {34},
  year         = {2011},
}

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