Our Clinical Trials
In recent years the supplements market has become saturated with natural bacteria products of all shapes and forms, boasting new delivery mechanisms, extremely high billions counts, numerous in-vitro tests and so on. Whilst in-vitro tests are extremely important1, it doesn't matter if a bacterial strain survives stomach acidity if it doesn't have a proven health benefit on the host! When selecting a supplement with live cultures, it is critical to question the number and quality of human clinical trials behind it.
OptiBac Probiotics on Trial
With OptiBac Probiotics, you can recommend a well-researched range with confidence. We have more than 150 published human clinical trials on finished products in our range,2,3 more than 200 published clinical trials on individual strains in our range,4,5 and a further 16 ongoing clinical trials which are yet to be completed and/or published6.
'For babies & children' (formerly 'For your child's health') shown to support immunity in children.7
The group taking 'For babies & children' had a 25% relative risk reduction in infections compared to placebo, and a 40% decrease in the relative risk of missing a day of school.
‘For those on antibiotics’ supports gut health in those on antibiotics.3
Here we summarise one of the numerous clinical trials on OptiBac Probiotics 'For those on antibiotics'. Details of other trials on this product can be found here.
244 participants aged 0-17 years with acute respiratory, urinary, or digestive problems were randomly split into two groups. 117 participants were given antibiotic therapy with ‘For those on antibiotics’ and 127 took antibiotic therapy alone.
Results show the ‘For those on antibiotics’ group were 1.5 times (significantly) less likely to develop antibiotic-associated diarrhoea, 10 times less likely to carry C. difficile and 8 times less likely to test positive for C. difficile toxins A + B, compared to the control group taking antibiotics only.
From this trial we can conclude that ‘For those on antibiotics’, when taken during a course of antibiotic therapy, gives significant gut health support to patients taking antibiotics; many of whom are concerned about the development of antibiotic-associated diarrhoea.
'Saccharomyces boulardii' (formerly ' For bowel calm') supports gut health.
Over 80 clinical trials have investigated the effect of the microorganism Saccharomyces boulardii, on a wide range of digestive complaints; including IBS, Crohn’s disease, ulcerative colitis and most notably, diarrhoea.
In one example8 92 adults with acute diarrhoea were randomised to receive either Saccharomyces boulardii or placebo. By the third day there had been a significant decrease in the severity of diarrhoea (calculated as the number of stools x consistency) in the S. boulardii group, from 22.7 to 5.5 (-17.2), whereas the placebo group saw significantly less of a decrease (-13.6). Furthermore the Saccharomyces boulardii group saw significant improvements in nausea scores, as well as increased patient satisfaction with the treatment, when compared to the placebo group.
High quality, published clinical trials are of critical importance in the rapidly developing world of microorganisms. The OptiBac Probiotics range is supported by a large number of clinical trials. The next time you recommend a supplement with natural bacteria or microorganisms, be sure to ask about the clinical evidence supporting it first.
For more information, and to see some of the trials, visit our scientific research page.
...And now you know that we have plenty of clinical trials, you can browse our product range in confidence!
Notes & References
1 Each strain in the OptiBac Probiotics range undergoes in-vitro testing for shelf stability, adhesion capabilities to cells in the intestinal lining, survival of gastric acidity & biliary salts, and good pathogen-inhibition. What’s more each strain, and finished product, is tested to meet excellent safety criteria.
2 Song H.J, et al (2010) Effect of probiotic Lactobacillus (Lacidofil® cap) for the prevention of antibiotic-associated diarrhoea: a prospective, randomised, double-blind, multicenter study. J Korean Med Sci 25 12 1784-91.
3 Maydannik, V. et al (2010) Efficiency and safety of Lacidofil in children with antibiotic-associated diarrhoea caused by Clostridium difficile. Paediatrics, Obstetrics and Gynaecology 3 53-57.
4 Ringel-Kulka T, et al (2011) Probiotic bacteria Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 versus placebo for the symptoms of bloating in patients with functional bowel disorders: a double-blind study. J Clin Gastroenterol 45 6 518-25
5 Mohan, R. et al (2006) Effects of Bifidobacterium lactis BB12 supplementation on intestinal microbiota of preterm infants: a double-blind, placebo-controlled, randomised study. J Clin Microbiol 44 11 4025-31
6 Full list of references for all published clinical trials available on request. For professional use only.
7 Cazzola, M. (2010) Efficacy of a synbiotic supplementation in the prevention of common winter diseases in children: a randomised, double-blind, placebo-controlled pilot study. Ther Adv Respir Dis 4 5 271-8
8 Saccharomyces boulardii in acute adult diarrhoea: Efficacy and tolerability of treatment. Höchter W, Chase D & Hagenhoff G Münch. Med. Wschr 132 12 188-192