The King’s College Hospital in London, UK, finished a 12-week clinical trial on 152 IBS patients in 2011 that found Symprove’s multi-strain probiotic improved typical symptoms associated with IBS . The findings have now been published in the Journal of Alimentary Pharmacology & Therapeutics – a move that worked to catch the attention of the medical world, Symprove’s chairman told NutraIngredients.
Barry Smith said initial unpublished findings had only generated interest among nutritionists. “To be frank, we struggled with the commercial uplift,” he said.
Because of that, Symprove decided to work on getting findings published in a high-level medical journal, he said. “What I’ve always argued you should do, is you’ve got to prove it to their [doctors] standards and work at their level.”
Smith said reaction to the publication so far had been incredible. “People are actually coming to us. It’s very exciting - we’ve got doctors and professors that want to talk to us... Doctors are taking Symprove seriously and recommending it for IBS.”
Symprove could play ‘significant role’ in IBS treatment
Symprove contains four strains of bacteria: Lactobacillus rhamnosus NCIMB 30174, Lactobacillus plantarum NCIMB 30173, Lactobacillus acidophilus NCIMB 30175 and Enterococcus faecium NCIMB 30176.
Findings showed that supplementation of the probiotic at 1mL/kg/day improved typical IBS symptoms. Abdominal pain and distension, bowel habits and quality of life were investigated in a 12-week randomised clinical trial.
On a scale of 0 – 500, patients taking the probiotic experienced a mean change in IBS symptom severity (IBS-SSS) of -63.3 versus -28.3 with the placebo.
“The multi-strain probiotic was associated with a statistically significant improvement in overall symptom severity in patients with IBS, and was well tolerated,” the researchers wrote.
The results were mainly due to improvements in patients’ perceived satisfaction of bowel habits and abdominal pain scores.
Researchers said the latter was particularly significant. “The significant change in the pain component score seen in this study is perhaps most relevant as pain is often regarded as the most important single symptom of IBS and is a good predictor of overall health status of the patient,” they wrote.
However, results indicated no overall improvement to quality of life. Despite this, the researchers said findings remained promising.
“IBS is a very complex condition with a wide range of contributing environmental factors. Thus, a multidisciplinary approach to treatment is essential for optimising outcomes. It seems increasingly likely that certain probiotics such as Symprove may play a significant role in the overall management of IBS. Nevertheless, our study may be limited by the study size, its single-centre design and should be followed up with a larger multi-centre trial.”
Study details: Randomised 12-week clinical trial
Patients with IBS took part in the single-centre, randomised, double-blind, placebo-controlled trial between October 2008 and June 2011 at King’s Collect Hospital. Of the 186 patients randomised 152 completed the 12-week study which involved three reviews at 4-weekly clinic visits.
The patients – men and women aged between 18 and 65 years – were symptomatic at the start of the study, chosen because of IBS-SSS of more than 150.
Two groups were given the probiotic and one the placebo, decided because the strain had never been studied formally in IBS patients. “It was therefore felt that including more patients in the probiotic arm 2:1) would yield more information about potential tolerance and side effects associated with this probiotic while controlling the cohort size for practical purposes as a single-centre study,” the researchers wrote.
The two probiotic groups were instructed to take 1mL/kg of refrigerated liquid probiotic each morning on an empty stomach.
Patients then rated the severity of their symptoms (abdominal pain and distension, satisfaction with bowel habit and the degree in which symptoms affect or interfere with quality of life) on a scale of 0 – 500, 500 being the worst. The scale measuring quality of life impact was based on 34 broad well-being issues including feelings of dysphoria, sexual relationships, social issues and body image, among others.
Source: Journal of Alimentary Pharmacology & Therapeutics
Published online ahead of print, doi: 10.1111/apt.12787. In print: 2014 July, Volume 40, Issue 1, Pages 51-62
"Randomised clinical trial: a liquid multi-strain probiotic vs. placebo in the irritable bowel syndrome – a 12 week double-blind study"
Authors: G. Sisson, S. Ayis, R. A. Sherwood and I. Bjarnason