Ruzhentsova TA, 2018 Russia
Comparison of BioGaia ORS with L. reuteri DSM 17938 and zinc vs. ORS product Rehydron + Bifidobac terium bifidum, for treatment of acute gastroenteritis in hospitalized children, 5 mo -13y. In addition to ORS, intestinal sor bents, antimicrobial and antipyretic therapy were used.
R, open
Product ingested until cessation of diarrhoea
L. reuteri: 30 (1×109 CFU/ sachet/250mL indivi dualized dosage) Rehydron: 30 individualized dosage B. bifidum: <1y: 1×108 CFU 2-3 times/d, >1y: 5×108 2-3 times/d
Compared to Rehydron + B. bifidum, BioGaia ORS:
• Significantly reduced duration of diarrhoea by 0.9 days 2.2 vs. 3.1 days)
• Abdominal pain ended significantly faster in the BioGaia ORSgroup: 0.3 days vs. 1.9 days.
• Acceptance of the BioGaia ORS was 100% vs. 73% (22/30) of Rehydron
Dinleyici EC, 2014
Turkey
The efficacy of L. reuteri DSM 17938 in children aged 3 – 60 mo, and hospitalized for acute diarrhoea. Both groups of children received conventional rehydration therapy, but the control group received no probiotic.
R, single blin ded (effects analyst) 5 days
L. reuteri: 64 (1×108 CFU) Control: 63
Compared to controls:
• L. reuteri significantly reduced the duration of diarrhoea
• The proportion of children with watery diarrhoea after 48h and 72h was significantly reduced
• Duration of hospital stay was significantly reduced
• Prolonged diarrhoea was only reported in the control group of children
Dinleyici EC, 2015
Turkey
The efficacy of L. reuteri DSM 17938 in children aged 3 – 60 mo, and treated as outpatients for acute diarrhoea. Both active and control group of children received conven tional rehydration therapy, but the control group received no probiotic.
R, single blin ded (effects analyst) 5 days
L. reuteri: 29 (1×108 CFU) Control: 31
Compared to controls:
• L. reuteri significantly reduced the duration of diarrhoea
• At 48h the proportion of children with watery diarrhoea was significantly reduced From the 72nd hour of intervention, there was no difference between the two groups in the percentage of children with watery diarrhoea
Francavilla R, 2012
Italy
Effect on acute gastroenteritis caused by rotavirus in children 6-36 months old, and hospitalized due to clinical signs of mild to moderate dehydration.
R, DB, PC 7 days
L. reuteri: 35 (2×108 CFU) Placebo: 34
Compared to placebo L. reuteri significantly:
• reduced the duration of diarrhoea by 1.2 days
• the frequency of watery diarrhoea was significantly reduced on treatment days 2 and 3
• the number of children with normal stool consistency was significantly higher on days 2 and 3
Eom T-H, 2005
South Korea
Reduction of symptoms in children hospitalized for acute gastroenteri tis and aged 6 mo – 3y.
R, DB, PC 5 days or until discharged
L. reuteri: 25 (2×108 CFU) Placebo: 25
L. reuteri significantly reduced:
• frequency of watery diarrhoea
• frequency of vomiting
• hospital stay
Shornikova A, 1997a
Finland
Treatment of children hospitalized for acute gastroenteritis and aged 6 mo – 3y.
R, DB, PC 5 days or until discharged
L. reuteri: 19 (1×1010–1×1011 CFU) Placebo: 21
L. reuteri significantly reduced:
• frequency of watery diarrhoea
• frequency of vomiting
Shornikova A, 1997b
Finland
Treatment of children hospitalized for acute rotavirus gastroenteritis and aged 6 mo – 3y.
R, DB, PC 5 days or until discharged
L. reuteri: 21 (1×1010 CFU) L. reuteri: 20 (1×107 CFU) Placebo: 25
L. reuteri in the high dose significantly reduced:
• duration of watery diarrhoea
• frequency of diarrhoea Positive, but non-significant, effects were seen also in the low dose group compared to placebo
Pernica JM, 2017
Botswana
Pilot trial to verify the feasibility of a trial designed to measure the bene fits of rapid enteric diagnostic testing (REDT) and L. reuteri DSM 17938 on acute gastroenteritis, recurrence of diarrhoea and growth in children aged 2-60 mo. and admitted to hos pital. In addition, the children were treated with standard rehydration therapy, zinc, and targeted antimi crobial treatment if indicated.
R, DB, PC 60 days
1. L. reuteri + REDT: 18 (1×108 CFU = 5 drops/d)
2. Placebo + RETD: 17
3. L. reuteri + stan dard care: 15 (1×108 CFU = 5 drops/d)
4. Placebo + standard care: 20
Rapid enteric diagnostic testing and L. reuteri supplementa tion for 60 days was associated with a significant increase in 60-day adjusted standardized height and significantly less recurrent diarrhoea compared to standard care and placebo treatment. Conclusions: Rapid diagnostics and L. reuteri DSM 17938 th erapy hold promise for the treatment of gastroenteritis and the prevention of stunting in children living in high-burden settings.
Maragkoudaki M, 2018
Greece
The efficacy of an oral rehydration solution (ORS) enriched with L. reuteri DSM 17938 and zinc, in children trea ted as outpatients for acute diarr hoea. The control group received an ORS of similar osmolarity but without the probiotic and zinc. Mean age of the children was 1.8 years.
R, DB, PC 5 days
L. reuteri: 28 (≈7×108 CFU/first 4 hours*) Control: 23 * 1 sachet of the probiotic ORS contai ned 1×109 CFU, to be blended with 250 mL of water
All of the outcomes showed a trend to superiority in the L. reuteri + zinc-ORS group without reaching statistical signifi cance compared to control for any of them.
The study enrolled too few subjects to be able to show any statistically significant differences between groups.
Szymański H 2019
Poland
Effects of L. reuteri DSM 17938 as an adjunct to oral rehydration therapy of children younger than 5 years, hospitalized for acute diarrhoea lasting ≤ 5 days.
R, DB, PC 5 days Followed-up for 3 days to investi gate any recurrence of diarrhoea
L. reuteri: 44 (2×108 CFU) Control: 47
Compared to placebo, the effects of L. reuteri were:
• Duration of diarrhoea was unaffected
• Duration of hospital stay was significantly reduced by 6h. This effect was more pronounced in children unvaccinated against rotavirus (75% of the study population) with a reduction of almost 10h (p<0.025).
• No difference in other outcomes including adverse events