Irritable bowel syndrome
Irritable bowel syndrome (IBS) is thought to have a prevalence of between 10-20% in most western countries. Symptoms can include pain and stomach cramps, diarrhoea, constipation and/or bloating. For sufferers it can be debilitating. There is no cure, though some patients find changes in diet and lifestyle helpful.
Qualitative and quantitative differences have been found in the gut luminal microbiota between healthy control subjects and patients with IBS. As such interventions which alter the intestinal bacterial composition are being increasingly explored.
A randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of Symprove in patients with symptomatic IBS was carried out. The study found a significant improvement in overall symptom severity.
G. Sisson, S. Ayis, R. A. Sherwood, I. Bjarnason (2014)
Randomised clinical trial: a liquid multi‐strain probiotic vs. placebo in the irritable bowel syndrome – a 12 week double‐blind study
Background:The importance of interactions between the host and gut microbiota in the pathogenesis of irritable bowel syndrome (IBS) is becoming increasingly apparent. Probiotics offer a potential new treatment for IBS, but current results are conflicting, largely as a result of poorly designed trials and non-standardisation of outcome measures.
Aim: To assess the efficacy of a liquid, multi‐strain probiotic (Symprove) in IBS.
Methods: A single‐centre, randomised, double‐blind, placebo‐controlled trial of adult patients with symptomatic IBS. Patients received 12 weeks of treatment with the probiotic or placebo (1 mL/kg/day). The primary efficacy measure was the difference in change in the IBS symptom severity score (IBS‐SSS) between probiotic vs. placebo at week 12. Secondary outcome measures included change in the IBS quality of life (IBS‐QOL) score and change in the IBS‐SSS symptom component scores.
Results: A total of 186 patients were randomised and 152 patients completed the study. The mean change in IBS‐SSS was −63.3 probiotic vs. −28.3 placebo. The mean difference in the IBS‐SSS was statistically significant [−35.0 (95% CI; −62.03, −7.87); P = 0.01]. There was no significant improvement in the IBS‐QOL. No serious adverse events were reported.
Conclusions: The multi‐strain probiotic was associated with a statistically significant improvement in overall symptom severity in patients with IBS, and was well tolerated. These results suggest this probiotic confers benefit in IBS and deserves further investigation (ISRCTN identifier: 77512412).
Diverticula are small bulges, or pockets, that can develop in the lining of the intestine as you get older. It is thought that approximately 1 in 3 over 60s and half of 80 year olds have these in their colon. Development of diverticula is traditionally linked to a low fiber diet. In most people the diverticula don’t cause symptoms and many people are unaware they have them. However, in some people the diverticula can cause symptoms such as lower abdominal pain, bloating, constipations and/or diarrhoea and sometimes mucus in stools, leading to a diagnosis of diverticular disease. If the diverticula become inflamed or infected this can lead to diverticulitis, causing more severe symptoms and can need surgical intervention. Some patients develop chronic symptoms – known as symptomatic uncomplicated diverticular disease (SUDD).
A double-blind, placebo-controlled trial to assess the ability of Symprove to reduce abdominal pain and other symptoms in elderly patients with SUDD was carried out. The study found no significant difference in the abdominal pain of sufferers, however it was found to:
- Significantly decrease the frequency of constipation and back pain
- Prevent exacerbation of intestinal inflammation in male patients
- Be associated with fewer episodes of diverticulitis during the trail than placebo in patient with frequent episodes of diverticulitis
Kvasnovsky CL, Bjarnason I, Donaldson AN, Sherwood RA, Papagrigoriadis S.
A randomized double-blind placebo-controlled trial of a multi-strain probiotic in treatment of symptomatic uncomplicated diverticular disease
Background: Diverticular disease is a significant burden on healthcare systems that is managed, surgically or medically, mainly as an emergency or acute condition. There are no standardized treatment recommendations for symptomatic uncomplicated disease. We hypothesized that a probiotic would reduce abdominal pain in such patients.
Methods: We conducted a single-center, double-blind, placebo-controlled trial of probiotic treatment (Symprove) in adult patients with moderate-to-severe chronic, non-acute symptomatic diverticular disease. 143 patients were randomized to receive 1 mL/kg/day of probiotic liquid (N = 72) or placebo (N = 71) daily for 3 months. The primary endpoint was abdominal pain severity. Secondary endpoints consisted of the change in the frequency of eight abdominal symptoms and the level of intestinal inflammation (fecal calprotectin).
Results: 120 patients completed the trial. Abdominal pain score, the primary end point, decreased in both groups, but no significant difference between the groups was found (P = 0.11). In relation to placebo, the probiotic significantly decreased the frequency of four of the eight secondary endpoints: constipation, diarrhea, mucorrhea, and back pain (P < 0.04). No significant differences were found in frequency of abdominal pain, PR bleeding, dysuria, and bloating.
Conclusions: Multi-strain liquid probiotic did not improve abdominal pain scores significantly, but significantly improved the frequency of four other symptoms associated with chronic, non-acute symptomatic diverticular disease.
Inflammatory bowel disease
Inflammatory bowel disease (IBD) primarily consists of two main conditions – ulcerative colitis (UC) and Crohn’s disease (CD). CD is thought to affect at least 115,000 people in the UK and UC around 146,000. Both are inflammatory disorders of the gastrointestinal tract (GIT), with UC affecting the mucosa of all, or part, of the colon and CD any part of the GIT. CD can be transmural. Symptoms of IBD can include abdominal pain diarrhoea and/or constipation, blood and/or mucus in stools, sickness and/or vomiting. Current treatments used are medication and surgery, though they are not always effective in inducing remission.
A growing body of evidence is showing that there is often dysbiosis of the microbiome in people with IBD (Ott et al, 2004; Frank et al, 2007; Manichanh et al, 2006). There is often a reduction in the abundance of the normally predominant phyla Firmicutes and Bacteroidetes, with an increase in the phylum Proteobacteria (of which Escherichia coli belongs) (Matsuoka & Kanai, 2015).
With this is mind a randomised, double-blind, placebo controlled trial took place to assess if Symprove taken for one month altered the quality of life in patients with UC and CD in clinical remission with only mild symptoms or reduced intestinal inflammation. The study found no significant changes to quality of life, however significant reductions in the median faecal calprotectin levels in UC patients taking Symprove were seen. No significant differences were seen in those with CD.
Guy Sisson, Bu Hayee, Ingvar Bjarnason
Assessment of a Multi Strain Probiotic (Symprove) in IBD
Background: With the knowledge that the intestinal microbiome may play a significant role in the pathogenesis of Inflammatory Bowel Disease (IBD) there is renewed interest in the possible treatment with probiotics. There are numerous open labeled studies and a few randomised controlled trials that show a significant symptomatic effect of probiotics in patients with active ulcerative colitis (UC) while the effects in Crohn’s disease (CD) seem to be lacking. It is not clear however whether the probiotics reduce intestinal inflammation.
Aim: A randomized, double-blinded, placebo controlled trial was undertaken to assess if the probiotic Symprove (a multistrain water based probiotic containing L. rhamnosus, E. faecium, L. acidophilus, and L. plantarum) taken for 1 month altered the quality of life in patients with UC and CD (primary outcome) in clinical remission with only mild symptoms or reduced intestinal inflammation (secondary outcome) as assessed by a faecal calprotectin test.
Methods: Eighty patients with UC and 80 with CD were planned. The study was stopped with 63 patients with CD because of slow recruitment. Patients included were aged 18-64, who were in clinical remission (mild to moderate disease activity, insufficiently severe as to escalate treatment). Patients with acute clinical relapse of disease, serious co-existing diseases or treatment with steroids or biologicals were excluded. IBDQ quality of life and faecal calprotectin were assessed before and after being randomized (2 stage computer randomisation utilising the Mersenne Algorithm) to receive the probiotic or a matching placebo (1 ml/kg body weight daily for one month).
Results: Primary outcome: There were no significant changes in IBDQ scores in any of the groups during the study. Secondary outcome: The median faecal calprotectin levels in UC treated with probiotic fell significantly (p < 0.01) (median 600 mg/kg (range 18.0-4800 mg/kg) to 343 mg/kg (range 10-2896 mg/kg) but not (p = 0.81) in the placebo treated patients (median 275 mg/kg (range 10-2024 mg/kg) v. 153 mg/kg (range 10-5000 mg/kg) pre and post, respectively. There were no significant differences (p = 0.35) between pre and post calprotectin levels in patients with CD treated with probiotic (median 425 mg/kg (range 41-4800 mg/kg) v. 355 mg/kg (range 20-2896 mg/kg)) or placebo (194 mg/kg (range 58-1128 mg/kg) v. 339 mg/kg (range 26-4800 mg/kg), p = 0.07). The differences in calprotectin levels between the active and placebo treated CD patients was not significant (p > 0.05).
Discussion: One month’s course of the probiotic Symprove had no significant effect on QOL assessments in patients with relatively quiescent UC or CD. However, intestinal inflammation was significantly reduced, as assessed by faecal calprotectin, in patients with UC, but not in CD.
https://www.gastrojournal.org/article/S0016-5085(15)31779-0/abstract *Awaiting publication