Scientific evidence of BIOFLOR

Formation UL réservée à l'usage interne. Reproduction pour communication externe interdite _ 5. UL/Les preuves cliniques/août 2009 _ version finale
Certaines études ne sont peut-être pas incluses dans votre RCP (Résumé des Caractéristiques du Produit)
Scientific evidence of
BIOFLOR

Meta-analysis
Dinleyici & al. Expert Opin Biol Ther. 2012 Apr 12 (4): 395-410.
NEW
2012

Meta-analysis
381 articles found 19 clinical trials selected:
utilization of S.boulardii for acute
infectious diarrhea
6 studies eliminated because:
• Adult population
• Giardiasis or amebiasis
11 studies included in the meta-
analysis on the duration of diarrhea
 1306 patients in total
 Daily dose of Sb from 250mg and 750mg / day
 All the studies with the same strain = Sb from Biocodex
 No adverse effects reported

Meta-analysis
Dinleyici EC, Expert Opin Biol Ther. 2012 Feb 16. [Epub ahead of print]
Dinleyici meta-analysis: Effectiveness and safety of Sb
for acute infectious diarrhea – Results
Reduction of approximately 1 day

for acute infectious diarrhea – Conclusions
Meta-analysis

Meta-analysis
for acute infectious diarrhea – Conclusions

Sb training exclusively for internal use. No copy for external communication_Poland_September 2012 8
Sb in the Prevention of Antibiotic- Associated Diarrhea in
Children. Kotowska, et al study
Kotowska et al. Alimentary Pharmacology And Therapeutics. 2005;21:583-590
Children

Aim
Patients
Design
Criteria
Children. Kotowska, et al study (2)
Children
Placebo + antibiotic (n = 127*)
Sb 250x2mg/d + antibiotic (n = 119*)
Duration of antibiotic treatment
*number of patients analyzed
To determine whether Sb prevents AAD in children
269 children, aged 6 months to 14 years with acute otitis
media and/or respiratory tract infection and receiving short-term
treatment with antibiotic were enrolled
Double-blind, randomized, placebo-controlled study
Primary: Frequencies of diarrhea and AAD
Secondary: Frequencies of rotavirus, Salmonella, Shigella, and C difficile
diarrhea; need for discontinuation of antibiotic treatment, hospitalization or IV
hydration; adverse events

Results
Children
Placebo
n=127
Sb
n=119
0
5
10
15
20
25
Diarrhea
- 67 %
RR (95% CI) : 0.3 (0.2-0.7)
NNT: 7 (5-16)
%Patientswithdiarrhea
23%
7.5%

Results
Children
0.0
5.0
10.0
15.0
20.0
Placebo (n=127) Sb (n=119)
- 81%
RR :(95% CI) 0.2
(0.07-0.5)
NNT : 8 (5-15)
Occurrence of Antibiotic-associated Diarrhea
%PatientswithAAD
17.3%
3.4%

 Secondary outcome measures
 C difficile diarrhea  Lower in Sb group (borderline of significance)
 No need for
 No adverse events reported  BIOFLOR is well tolerated
Children
Results
Discontinuation of
antibiotic treatment
Hospitalization
IV hydration

 “Results from this prospective study support the use of Sb
as adjunctive treatment in children undergoing antibiotic
therapy for otitis media and/or respiratory tract infections.”
 “This is the first RCT to assess the effectiveness of S.
boulardii in preventing AAD in children.”
 “The likely advantages of probiotic co-administration with
antibiotics include ease of administration and potential cost
benefits.”
Kotowska, et al. Alimentary Pharmacology And Therapeutics. 2005;21:583-590
Children
Conclusion

JAMA
2012
Meta-analysis
Hempel S. & al. JAMA. 2012 May 9;307(18):1959-69. doi: 10.1001/jama.2012.3507.

Meta-analysis
Hempel et al. meta-analysis: Probiotics for the prevention
and treatment of AAD
2426 full articles found on
probiotic use during AAD
82 randomized clinical trials
selected
19 studies eliminated because did not
reported the number of patients:
• With diarrhea
• Randomized to both treatment groups
63 studies included in the
meta-analysis on the effect
of probiotics on AAD
 15 RCTs on Saccharomyces boulardii
 Highest number of RCT on 1 strain
 In the majority of RCTs  No adverse effects reported

Probiotics decrease the risk of developing
AAD by 42%
and treatment of AAD – Results
Meta-analysis
Saccharomyces decreases the risk of
developing AAD by 52%

 « The relative efficacy of probiotic interventions may be strain
specific »
 More research needed
Meta-analysis
and treatment of AAD – Conclusion
Which patients receiving which
specific antibiotics
Which probiotics are associated with
the greatest efficacy

Antibiotic Associated Diarrhea (AAD)
McFarland 2010 meta-analysis
 Representing 1869 patients in total
 Importance to have a meta-analysis on:
 A single strain of probiotic and not on an association or on “probiotics” in general
 On a precise indication
322 citations with
S.boulardii
278 were not studies on S.boulardii
44 randomized controlled
trials
34 studies eliminated because:
• Pediatric population
• Not AAD indication in adults
10 studies analyzed
The efficacy of a probiotic is
strain-dependent
Meta-analysis
L McFarland WJG 2010 May 14; 16(18): 2202-2222

L McFarland WJG 2010 May 14; 16(18): 2202-2222
Results
PRECOSA decreases the risk of
developing AAD by 53%
Antibiotic Associated Diarrhea (AAD)
Meta-analysis

Sb training exclusively for internal use. No copy for external communication_ 5.Sb/Clinical Evidences// 08.2012
Some studies may not belong to your SmPC (Summary of Product Characteristics)
Conclusion
 Bioflor is effective in the treatment of
gastroenteritis in its entirety :
 Diarrhea
 Nausea and vomiting
 Fever
 Stomach Cramps
 Bioflor is effective in all types of infectious
diarrhea:
 Viral
 Bacterial
 Parasitic

Formation UL réservée à l'usage interne. Reproduction pour communication externe interdite _ 3. UL/Historique et PK/Mars 2010_ short_ 21
 Bioflor provides an economic and social benefit by reducing
absenteeism and direct and indirect health costs
 There are important differences between yeasts and bacteria
 Bioflor reduces by 53% the risk of developing antibiotic-
associated diarrhea
 Bioflor reduces by 25% the days with diarrhea in
tube-fed patients
Conclusion (2)

Scientific evidence of BIOFLOR

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Scientific evidence of BIOFLOR