Madempudi, Ratna Sudha http://orcid.org/0000-0003-1819-722X
Neelamraju, Jayanthi
Ahire, Jayesh J.
Gupta, Sandeep K.
Shukla, Vineet K.
Article History
First Online: 25 March 2019
Compliance with Ethical Standards
: This study was conducted in compliance with the code of conduct for research involving human volunteers as issued by the International Conference on Harmonisation–Good Clinical Practice (ICH-GCP), Indian Council of Medical Research guidelines (ICMR; ethical guidelines for biomedical research on human subjects) and the principles of the Declaration of Helsinki. Informed consent forms were approved by the ethical committees of study sites and the trial was registered prospectively with the clinical trial registry of India (CTRI/2017/11/010539). The study was initiated after obtaining informed consent.
: R.S.M., J.N. and J.J.A. are employed by Unique Biotech Ltd. which is a manufacturer of probiotics. They wish to state that the study was conducted independently with no intervention on their part during the duration of the study.