“The study confirmed that the B. coagulans MTCC 5856 is safe for human consumption as a dietary supplement at a dose of 2 × 109 cfu/day,” the researchers of Sabinsa’s study wrote in the Nutrition Journal.
The pilot study was a double blind randomized placebo controlled clinical study done on 36 newly diagnosed diarrhea-predominant irritable bowel syndrome (IBS) patients, a population which the researchers said the effects of the probiotic strain “has not been clinically elucidated till date.”
“This particular study expresses without any doubt that LactoSpore can reach an end-point, particularly with such a disorder as IBS, and help create relief,” Shaheen Majeed, Marketing Director at Sabinsa, told NutraIngredients-USA
One of the basic criteria to select study participants was a diagnosis of IBS and whether or not they have exhibited symptoms within the last three months.
The 36 participants were then divided into two equally-sized groups. All participants were given the two standard drugs to treat IBS symptoms, a combination of Domperidone 30 mg and Esomeprazole 40 mg, and Metronidazole 400 mg. Then, depending on group, participants were either given Sabinsa’s B. Coagulans MTCC 5856 (LactoSpore) with 2 billion spores per tablet, or a placebo, daily for 90 days.
A decrease in IBS symptoms
Study participants were evaluated in three different clinics, and clinical IBS symptoms were considered the primary end point measure evaluated through questionnaires, while a visual analog scale (VAS) was used for abdominal pain.
“The patients who received [the probiotic tablet] had a significant change/decrease in clinical symptoms like bloating, vomiting, diarrhea, abdominal pain, and stool frequency, whereas the placebo arm did not exhibit any such improvement,” the report said.
Moreover, all anthropometric measurements and vital signs were within the normal range during the 90 days of supplementation, and there were no statistical difference between both the treatment groups.
Probiotics are thriving
While the potential role of bacteria was first hypothesized in the early 20th Century by Élie Metchnikoff, and the term 'probiotic' was coined in the 1960s, an official definition by the World Health Organization was not released until 2001 ("live micro-organisms which, when administered in adequate amounts, confer a health beneﬁt on the host"). Despite a century of scientific interest and research some regulatory entities, such as the European Food Safety Authority, are yet to be convinced by the science (though it seems like they’re turning the corner).
This is why manufacturers like Sabinsa are initiating and funding research. “It is our belief that these efforts will help bring more credibility as a whole for the dietary supplement market, something which has been questioned by critics of this industry,” Majeed said. “Having solid science gives a product an advantage in the market place but more importantly also helps to give confidence to the consumers who buy these dietary supplements and trust they will help them achieve better health.”
As more policy makers are easing up on how they regulate probiotics, it seems like the ingredient industry and manufacturers won’t be alone in their probiotic research, as some governments are supporting more research on it. Based on the multiple innovations of how these bacteria are incorporated in food, beverages, supplements, and everything in between, consumers are getting the message of its benefits.
“The Probiotic segment is one of the fastest growing segments of the Dietary supplement marketplace, with a very positive outlook for the next few years to come,” Majeed said. Media investment in the US has bolstered the category, far surpassing its European counterpart. Data from SPINS reported a year-over-year 20.4% increase in pre- and probiotic supplements to $12,923,656 in the US as of the week ending Jan. 25, 2016.