Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: A double blind randomized placebo controlled pilot clinical study
Nutr J. 2016;15:21. doi: 10.1186/s12937-016-0140-6
Several health benefits are known to be associated with probiotics consumption, including immune-boosting, protection against diarrheal diseases, nosocomial and respiratory tract infections, cholesterol lowering effects, attenuation of overt immune-inflammatory disorders and anti-cancer activities.
Lactobacillus and Bifidobacterium are the genera that most probiotic microorganisms belong to; however, some bacteria and yeast strains are also known to possess probiotic properties.
Due to the awareness about the benefits of probiotics in gut health and disease prevention and therapy, commercial interest in functional foods containing probiotics strains is gaining importance. As a result, preliminary research has suggested that some strain specific probiotics are possibly helpful in treating various forms of gastroenteritis.
To evaluate the safety and efficacy of Bacillus coagulans MTCC 5856 (LactoSpore®), as a dietary supplement, in patients receiving standard care of treatment for diarrhoea-predominant irritable bowel syndrome (IBS).
- It was a randomized, double-blind, parallel group, placebo-controlled, multi-centered study involved 36 subjects
- Each subject was randomized in a 1:1 ratio and asked to self administer one tablet of LactoSpore® (each tablet containing 2×109 cfu) as a dietary supplement in addition to either standard treatment or placebo for a period of 90 days
- A gap of at least 4h between the study product (placebo/active) and standard care of treatment was maintained
- Primary end point was evaluation of clinical symptoms of IBS, whereas secondary efficacy measures involved Physician’s global assessment and IBS quality of life, and both were measured through questionnaires
- Visual analog scale (VAS) was used to evaluate abdominal pain
Results and Discussion:
- During the study period, both groups showed normal laboratory parameters, anthropometric and vital signs, within the normal clinical range
- Participants receiving LactoSpore® showed a significant decrease (p<0.01) in the clinical symptoms, such as bloating, vomiting, diarrhoea, abdominal pain and stool frequency compared to placebo group (Table 1)
- Additionally, LactoSpore® group showed decreased disease severity (i.e. Physician’s global assessment) and better IBS-quality of life compared to placebo group (Fig. 1A and 1B, respectively)