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WITHDRAWN: Response to the article “Microbiological and molecular characterization of commercially available probiotics containing Bacillus clausii from India and Pakistan”
Accepted Manuscript Response to the article “Microbiological and molecular characterization of commercially available probiotics containing Bacillus clausii from India and Pakistan”
Aruna Poojary, Seema Rohra, Anurag Kumar Bari PII: DOI: Reference:
S0168-1605(18)30313-1 doi:10.1016/j.ijfoodmicro.2018.06.008 FOOD 7944
To appear in:
International Journal of Food Microbiology
Received date: Accepted date:
2 May 2018 10 June 2018
Please cite this article as: Aruna Poojary, Seema Rohra, Anurag Kumar Bari , Response to the article “Microbiological and molecular characterization of commercially available probiotics containing Bacillus clausii from India and Pakistan”. Food (2017), doi:10.1016/ j.ijfoodmicro.2018.06.008
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Correspondence: Response to the article “Microbiological and molecular characterization of commercially available probiotics containing Bacillus clausii from India and Pakistan”
Aruna Poojary, Seema Rohra, Anurag Kumar Bari
PT
Dept. of Pathology & Microbiology, Breach Candy Hospital Trust To ,
RI
The Editor
SC
Sir,
We read the article “Microbiological and molecular characterization of commercially
NU
available probiotics containing Bacillus clausii from India and Pakistan” written by Patrone V and colleagues and published in your esteemed journal in November 2016 issue.1 We read this article with great interest and appreciate the methods used for microbiological and
MA
molecular characterization of probiotics and applaud the premise on which the study was performed from the point of view that strain specificity, purity and appropriate concentrations
D
are essential elements of any probiotic supplementation. However, after reading the article carefully, we found following observations which might introduce bias in the study conduct
PT E
and interpretation of results.
The authors have not mentioned the study design. Overall, the design looks like an open label study. If so, the study design introduces a major bias which needs to be taken into
CE
consideration while interpreting the results. The investigators should have used operator blinded study design. There is absence of controls for Bacillus claussi both in the phenotypic
AC
assays and genotypic assays. Although authors have disclosed the support provided by a pharmaceutical company (Sanofi-Aventis, France), the bias because of the study design can’t be ruled out.
Colony counts for each batch were performed in triplicates, but the bacterial spore counts are presented as single result. The results should have been presented as mean and standard error of mean. Inter observer variations are expected while counting the bacterial spores. It is intriguing to see the complete concordance in the bacterial spore counts of two batches for Enterogermina, whereas there is considerable variation in the count of spores for other products. Blinded study design could have helped to overcome this bias. The statement in the section 3.1 of the manuscript reads as “The bacterial/spore count analysed using the plate
ACCEPTED MANUSCRIPT count method showed poor correlation with label indications for three of the five analysed products. Enterogermina and Entromax matched the label claim (2 X 109 spores/5 ml and 2 X 109 CFU/g, respectively)”. The readings given for Enterogermina are per ml and if calculated for 5 ml, they do not match 2 X 109 spores. The study should have been supported with pictures of varying colony morphologies. Despite factors discussed above that have potential to introduce bias, the authors have not included a statement on limitations of the study.
PT
Considering this, we feel that these results should be carefully extrapolated.
RI
Reference:
1. Patrone V, Molinari P, Morelli L. Microbiological and molecular characterization of
SC
commercially available probiotics containing Bacillus clausii from India and Pakistan.
AC
CE
PT E
D
MA
NU
Int J Food Mirobiol 2016;237:92-97
Aruna Poojary, Seema Rohra, Anurag Kumar Bari PII: DOI: Reference:
S0168-1605(18)30313-1 doi:10.1016/j.ijfoodmicro.2018.06.008 FOOD 7944
To appear in:
International Journal of Food Microbiology
Received date: Accepted date:
2 May 2018 10 June 2018
Please cite this article as: Aruna Poojary, Seema Rohra, Anurag Kumar Bari , Response to the article “Microbiological and molecular characterization of commercially available probiotics containing Bacillus clausii from India and Pakistan”. Food (2017), doi:10.1016/ j.ijfoodmicro.2018.06.008
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Correspondence: Response to the article “Microbiological and molecular characterization of commercially available probiotics containing Bacillus clausii from India and Pakistan”
Aruna Poojary, Seema Rohra, Anurag Kumar Bari
PT
Dept. of Pathology & Microbiology, Breach Candy Hospital Trust To ,
RI
The Editor
SC
Sir,
We read the article “Microbiological and molecular characterization of commercially
NU
available probiotics containing Bacillus clausii from India and Pakistan” written by Patrone V and colleagues and published in your esteemed journal in November 2016 issue.1 We read this article with great interest and appreciate the methods used for microbiological and
MA
molecular characterization of probiotics and applaud the premise on which the study was performed from the point of view that strain specificity, purity and appropriate concentrations
D
are essential elements of any probiotic supplementation. However, after reading the article carefully, we found following observations which might introduce bias in the study conduct
PT E
and interpretation of results.
The authors have not mentioned the study design. Overall, the design looks like an open label study. If so, the study design introduces a major bias which needs to be taken into
CE
consideration while interpreting the results. The investigators should have used operator blinded study design. There is absence of controls for Bacillus claussi both in the phenotypic
AC
assays and genotypic assays. Although authors have disclosed the support provided by a pharmaceutical company (Sanofi-Aventis, France), the bias because of the study design can’t be ruled out.
Colony counts for each batch were performed in triplicates, but the bacterial spore counts are presented as single result. The results should have been presented as mean and standard error of mean. Inter observer variations are expected while counting the bacterial spores. It is intriguing to see the complete concordance in the bacterial spore counts of two batches for Enterogermina, whereas there is considerable variation in the count of spores for other products. Blinded study design could have helped to overcome this bias. The statement in the section 3.1 of the manuscript reads as “The bacterial/spore count analysed using the plate
ACCEPTED MANUSCRIPT count method showed poor correlation with label indications for three of the five analysed products. Enterogermina and Entromax matched the label claim (2 X 109 spores/5 ml and 2 X 109 CFU/g, respectively)”. The readings given for Enterogermina are per ml and if calculated for 5 ml, they do not match 2 X 109 spores. The study should have been supported with pictures of varying colony morphologies. Despite factors discussed above that have potential to introduce bias, the authors have not included a statement on limitations of the study.
PT
Considering this, we feel that these results should be carefully extrapolated.
RI
Reference:
1. Patrone V, Molinari P, Morelli L. Microbiological and molecular characterization of
SC
commercially available probiotics containing Bacillus clausii from India and Pakistan.
AC
CE
PT E
D
MA
NU
Int J Food Mirobiol 2016;237:92-97