LactoSpore probiotic from Sabinsa granted new patent for depression symptoms in IBS patients

Photo © iStockphoto.com/Jacob Wackerhausen

Sabinsa (East Windsor, NJ) has been granted U.S. patent US10166261 for the administration of Bacillus coagulans MTCC 5856 (LactoSpore) at a dose of 2 billion colony forming units (CFU) per day as a way to manage dementia and dementia-related sleep disorders, presented as symptoms of major depressive disorder (MDD), in humans with Irritable Bowel Syndrome (IBS). The patent also claims LactoSpore’s ability to reduce serum myeloperoxidase, an essential biochemical marker of MDD.

The patented is supported by a randomized, double-blind, placebo-controlled multi-center, pilot clinical study published in Food & Nutrition Research¹. In the study, 40 patients diagnosed for MDD with IBS were randomized to receive 2 billion CFU of LactoSpore or placebo for 90 days. Subjects taking the probiotic experience significant changes in the primary outcome measures of Hamilton Rating Scale for Depression (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Center for Epidemiological Studies Depression Scale (CES-D), and Irritable bowel syndrome quality of life questionnaire (IBS-QOL). Secondary outcome measures of Clinical Global Impression-Improvement rating Scale (CGI-I), Clinical Global Impression Severity rating Scale (CGI-S), Gastrointestinal Discomfort Questionnaire (GI-DQ), and Modified Epworth Sleepiness Scale (mESS) also showed significant changes in the probiotic group.

“It is gratifying that the US patent office recognized the strain specific action of Sabinsa’s MTCC 5856 in allowing the claims,” said Shaheen Majeed, president worldwide, Sabinsa, in a press release. “We anticipate being granted patents on the discovery in additional countries in the near future.”

References:

1. Majeed M. et al. “Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, doubleblind, placebo controlled, multi-centre, pilot clinical study.” Food & Nutrition Research, vol. 62 (2018)