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Therapy-Related Side Effects and Their Prevention


Antibiotic-Associated Side Effects in Children and Adults

Reference

Cimperman L, 2011 USA

Study Objectives

Prevention of antibiotic-associated diarrhoea or infectious in hospitali zed adults, mean age 51y.

Study Design*

R, DB, PC 4 weeks + 2w follow-up

No. of Subjects (dose)

L. reuteri: 13 (2×108 CFU) Placebo: 10

Results

Significantly reduced incidence of diarrhoea: 7.7% in L. reuteri group and 50% in placebo

Reference

Kołodziej M, 2018 Poland

Study Objectives

Efficacy of drops with L. reuteri DSM 17938 in prevention of antibiotic-as sociated (AAD) or other diarrhoea in hospitalized children <18y. Episode of diarrhoea defined in three ways based on severity (≥3 or loose or watery stools/24h for a minimum of 48h or 24h, and ≥ 2 loose or watery stools/24h for a minimum of 24h). AAD was diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea.

Study Design*

R, DB, PC

9 days (mean) in both groups = during anti biotic therapy (oral or intrave nous). Follow-up at day 7 post antibiotic.

No. of Subjects (dose)

L. reuteri: 123 (2×108 CFU) Placebo: 124

Results

• Incidence of AAD by the strictest definition was 11.4% and 6.5% in the L. reuteri and placebo group, respectively, and 13% and 13.7%, respectively, for AAD by any of the other two definitions.
• Incidence and type of adverse events were similar
• Median age of subjects was 4 mo, mean age was 26 mo

Reference

Georgieva M, 2015 Bulgaria

Study Objectives

To evaluate the preventive effect of L. reuteri DSM 17938 on antibiotic associated diarrhoea and Clostri dium difficile-related infections in hospitalized children, 3-12 years old.

Study Design*

R, DB, PC Study product ingested during the antibiotic cour se and 7 days thereafter. Follow-up at 21 days post-antibiotic treatment

No. of Subjects (dose)

L. reuteri: 49 (1×108 CFU) Placebo: 48

Results

The incidence of diarrhoea was unexpectedly low with only one case in each group. Hence, the study was underpowered to be able to detect any statistical differences between groups. There were no Cl. difficile-related infections, and no differences between groups on proportion of subjects who were positive for Cl. difficile toxin A and B at baseline and on day 21, respectively. There were no differences between groups on the incidence of other GI-related symptoms.
The study products were well tolerated and there was no report of any adverse events.