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Abstract

Objectives: To determine if Lactobacillus plantarum DSM9843 (LP299V) reduces the frequency of antibiotic-associated loose/watery stools and gastrointestinal symptoms, and can be administered safely to children who are prescribed antibiotics.

Study design: We performed a prospective, double-blind, randomized, placebo-controlled, multicenter, parallel-group study in children receiving outpatient antibiotic therapy in primary healthcare settings. The children were given LP299V/placebo during the antibiotic therapy and for 1 week after the end of treatment. The primary outcome measure was the incidence of at least 1 loose/watery stool (type 6 or 7 according to the Bristol Stool Form Scale). Gastrointestinal symptoms (abdominal pain, abdominal distention, vomiting, and flatulence) were followed up until 1 week after the last intake of the study product.

Results: A total of 438 children (male: 235, female: 203) aged 1-11 years (mean ± SD: 5.2 ± 2.7) were randomized to receive LP299V (N = 218) or placebo (N = 220). The incidence of loose/watery stools in the 2 study groups (LP299V and placebo) was similar, 39% vs 44.5% respectively (P = .26) as was the mean number of loose/watery stools (3.9 ± 3.5 vs 4.7 ± 6.3; P = .9). Antibiotic-associated diarrhea (defined as ≥3 loose/watery stools/24 hours starting from 2 hours after initiation of antibiotic treatment until the end of the study) occurred in 2.8% of the subjects receiving LP299V compared with 4.1% in the placebo arm (P = .4). The number of children with abdominal symptoms did not differ between the groups.

Conclusions: No beneficial effect of LP299V compared with placebo was observed for the incidence of loose/watery stools, mean number of loose/watery stools, or the incidence of abdominal symptoms. LP299V had a satisfactory safety profile.

Trial registration: ClinicalTrials.gov: NCT01940913.

Keywords: diarrhea; probiotics.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Lactobacillus plantarum DSM 6595Increased Abdominal Symptoms in Children Taking AntibioticsNeutral
Small
Lactobacillus plantarum DSM 6595Increased Frequency of Loose or Watery StoolsNeutral
Small
Lactobacillus plantarum DSM 6595Reduced Antibiotic-Associated Diarrhea in ChildrenNeutral
Small
Lactobacillus plantarum DSM 6596Increased Incidence of Abdominal SymptomsNeutral
Small
Lactobacillus plantarum DSM 6596Reduced Incidence of Loose StoolsNeutral
Small
Lactobacillus plantarum DSM 6596Reduced Stool VolumeNeutral
Small
Lactobacillus plantarum LP-01Reduced Abdominal SymptomsNeutral
Small
Lactobacillus plantarum LP-01Reduced Antibiotic-Associated DiarrheaNeutral
Small
Lactobacillus plantarum LP-01Reduced Incidence of Loose StoolsNeutral
Small
Lactobacillus plantarum LP-01Reduced Stool VolumeNeutral
Small
Lactobacillus plantarum LP09Increased Frequency of Loose or Watery StoolsNeutral
Small
Lactobacillus plantarum LP09Reduced Abdominal SymptomsNeutral
Small
Lactobacillus plantarum LP09Reduced Antibiotic-Associated DiarrheaNeutral
Small
Lactobacillus plantarum Lp-115Improved Safety ProfileNeutral
Moderate
Lactobacillus plantarum Lp-115Reduced Abdominal SymptomsNeutral
Small
Lactobacillus plantarum Lp-115Reduced Antibiotic-Associated DiarrheaNeutral
Small
Lactobacillus plantarum Lp-115Reduced Incidence of Loose StoolsNeutral
Small
Lactobacillus plantarum Lp-115Reduced Stool VolumeNeutral
Small

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