Our Clinical Trials

Kerry Beeson BSc (Nut. Med.) Nutritional Therapist

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 (see Probiotics Learning Lab for more glossary terms) tests and so on. Whilst in-vitro tests are extremely important1, it doesn't matter if a bacterial strain survives stomach acidity if it hasn't been demonstrated to offer a health benefit to the host! When selecting a supplement with live cultures (see Probiotics Learning Lab), it is therefore critical to question the number and quality of the human clinical trials behind it.

OptiBac on Trial

With the OptiBac brand, you can be confident that you're receiving a well-researched range. There are more than 160 published human clinical trials on finished products in the range,2,3 more than 200 published clinical trials on individual strains in the range,4,5 and a further 16 ongoing clinical trials which are yet to be completed and/or published6.

'For babies & children' researched for immunity in children7

In one significant clinical trial, 135 children were enrolled and randomly allocated into two groups. 62 of the children received 'For babies & children' and 73 received a placebo, over a 3-month winter period.

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’ researched for the support of gut health in those taking antibiotics3

The strains of bacteria in 'For those on antibiotics' have been featured in numerous clinical trials. You can read more about other trials on a strain contained in this product here.

In one of the most notable studies, 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 indicated that those in the ‘For those on antibiotics’ group were 1.5 times 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.

The evidence from this trial suggests that ‘For those on antibiotics’, when taken during a course of antibiotic therapy, may offer support for gut health in patients taking antibiotics.

'Saccharomyces boulardii' (formerly 'For bowel calm') researched for the support of diarrhoea symptoms.

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 a 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 Saccharomyces 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 range is supported by a large number of clinical trials. The next time you consider a supplement with natural bacteria or microorganisms, be sure to ask about the clinical evidence supporting it first.

Notes & References:

1 Each strain in the OptiBac 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