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Acute Gastroenteritis (AGE)


AGE Prevention in Children

Study Objectives

Evaluate if daily administration of L. reuteri DSM 17938 reduces the frequency and duration of diarrhoea episodes and respiratory tract infections (RTI) in Mexican day school children aged 6-36 months. A cost-effectiveness analysis was also made

Study Design*

R, DB, PC 3 months of intervention, follow-up at 6 months

No. of Subjects (dose)

L. reuteri: 168 (1×108 CFU) Placebo: 168

Results

Compared to placebo:
• L. reuteri significantly reduced the frequency and duration of episodes of diarrhoea and respiratory tract infection at both 3 and 6 months
• he number of doctor visits, antibiotic use, absenteeism from day school and parental absenteeism from work were signifi cantly reduced
• The use of L. reuteri was associated with a reduction of costs by 36 US dollars (USD) for each case of diarrhoea, and by 37 USD for each case of RTI

Reference
Study Objectives

Prevention of common infections in day-care children 4–10 months old.

Study Design*

R, DB, PC 12 weeks

No. of Subjects (dose)

L. reuteri: 68 (1.2×109 CFU) Bb-12: 73 (1.2×109 CFU) Control: 60

Results

L. reuteri significantly reduced (compared to Bb-12 and control):
• Days with fever
• Need to consult doctor and need of antibiotics
• Absence from day-care Both probiotics significantly reduced:
• Episodes with fever
• Episodes and days with diarrhoea

Reference
Study Objectives

To investigate milk with low and re gular calcium content, respectively, and the addition of probiotics (L. reuteri DSM 17938 or L. casei CRL431) to milk with regular calcium con tent, on the incidence and duration of diarrhoea and acute respiratory infections in healthy Indonesian children, 1-6y old.

Study Design*

R, DB, PC 6 months

No. of Subjects (dose)

L. reuteri: 124 (5×108 CFU) L. casei: 120 (5×108 CFU) Low calcium milk: 124 Regular calcium milk: 126

Results

Only L. reuteri significantly reduced:
• Incidence of diarrhoea in children with lower nutritional sta tus, irrespective of definition of diarrhoea
• Incidence of diarrhoea in all children when diarrhoea was defined as ≥ 2 loose/liquid stools/24h instead of ≥ 3 loose/ liquid stools/24h The interventions had no effect on incidence or duration of acute respiratory infection

Reference

Agustina R, 2012b (substudy of Agustina 2012a) Indonesia

Study Objectives

To investigate milk with low and regular calcium content, respectively, and the addition of probiotics (L. reuteri DSM 17938 or L. casei CRL431) to milk with regular cal cium content, on the incidence and duration of acute diarrhoea due to rotavirus or other causes in healthy Indonesian children, 1-6y old.

Study Design*

R, DB, PC 6 months

No. of Subjects (dose)

L. reuteri: 124 (5×108 CFU) L. casei: 120 (5×108 CFU) Low calcium milk: 124 Regular calcium milk: 126

Results

• L. reuteri significantly reduced the duration of diarrhoea in affected children
• Rotavirus-positive episodes were significantly shortened by L. reuteri and by calcium
• L. casei shortened the duration of rotavirus-negative episo des

Reference
Study Objectives

The efficacy of L. reuteri DSM 17938 in prevention of nosocomial diarr hoea in hospitalized children, 1-48 months old.

Study Design*

R, DB, PC During hospi tal stay

No. of Subjects (dose)

L. reuteri: 54 (1×108 CFU) Placebo: 52

Results

L. reuteri did not affect the incidence of hospital-acquired diarrhoeal disease.

Reference
Study Objectives

The efficacy of L. reuteri DSM 17938 in prevention of nosocomial diarr hoea in hospitalized children, 1-48 months old. A repeat of Wanke’s trial with a 10 times higher dose.

Study Design*

R, DB, PC During hospi tal stay

No. of Subjects (dose)

L. reuteri: 91 (1×109 CFU) Placebo: 93

Results

L. reuteri did not affect the incidence of hospital-acquired diarrhoeal disease.
There was also no difference between the L. reuteri and placebo groups for any of the secondary outcomes, including adverse effects. Rotavirus vaccination status had no impact on the results.

Reference

Weizman Z, 2009 (abstract, follow-up of Weizman, 2005) Israel

Study Objectives

To evaluate if day-care infants acquire a long-term protection against common infections, fol lowing a probiotic supplementation period.

Study Design*

R, DB, PC Follow-up af ter 12 weeks

No. of Subjects (dose)

L. reuteri: 66 (1.2×109 CFU) Bb-12: 69 (1.2×109 CFU) Control: 59

Results

• Protection only observed during supplementation period
• No long-term protection against common infections for any of the probiotics compared to control