Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2019 Jun;27(3):465-473.
doi: 10.1007/s10787-019-00595-4. Epub 2019 May 3.

A randomised, double-blind, placebo-controlled trial of a multi-strain probiotic in patients with asymptomatic ulcerative colitis and Crohn's disease

Ingvar Bjarnason  1 , Guy Sission  2 , Bu'Hussaine Hayee  3
Affiliations
Randomized Controlled Trial

A randomised, double-blind, placebo-controlled trial of a multi-strain probiotic in patients with asymptomatic ulcerative colitis and Crohn's disease

Ingvar Bjarnason et al. Inflammopharmacology. 2019 Jun.

Abstract

Background: There is considerable interest in the possible importance of the gut microflora in the pathophysiology of the inflammatory bowel diseases (IBD) ulcerative colitis (UC) and Crohn's disease (CD). Probiotics offer a potential adjuvant treatment in these patients by modifying the intestinal milieu, but reports of their efficacy are conflicting.

Aims: To assess the efficacy of a multi-strain probiotic (Symprove™, Symprove Ltd, Farnham, United Kingdom) in quality of life issues and intestinal inflammation in patients with asymptomatic UC and CD.

Methods: A single-centre, randomised, double-blind, placebo-controlled trial of adult patients with asymptomatic IBD. Patients received 4 weeks of treatment with the probiotic or placebo (1 ml/kg/day). The primary efficacy measure was the difference in change in the IBD Quality of Life Questionnaire results (QOL) between probiotic vs. placebo at week 4. Secondary outcome measures included analyses of the change in laboratory findings, including faecal calprotectin (FCAL).

Results: Over 500 patients were recruited to the study and 81 and 61 patients with UC and CD, respectively were randomised and completed the study. There were no significant differences in IBD-QOL scores between placebo and the probiotic groups. Similarly, there were no significant changes observed in the laboratory data. However, the differences in FCAL between patients with UC before and after probiotics versus placebo approached statistical significance with a p value of 0.076. Post-hoc analyses showed that the FCAL levels were significantly (p < 0.015) reduced in the UC patients receiving the probiotic as opposed to placebo. No significant changes were seen in CD. No serious adverse events were observed.

Conclusion: This multi-strain probiotic is associated with decreased intestinal inflammation in patients with UC, but not in CD and is well tolerated. Further research is required to see if the probiotic reduces the incidence of clinical relapses in asymptomatic IBD patients.

Keywords: Alternative therapy; Complementary; IBD; Probiotic.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Individual change in FCAL levels in the study groups. The green bars indicate a reduction in FCAL levels whilst the red bars indicate an increase (color figure online)
See this image and copyright information in PMC

References

    1. Bensoussan M, Jovenin N, Garcia B, Vandromme L, Jolly D, Bouché O, Thiéfin G, Cadiot G. Complementary and alternative medicine use by patients with inflammatory bowel disease: results from a postal survey. Gastroenterol Clin Biol. 2006;30:14–23. doi: 10.1016/S0399-8320(06)73072-X. - DOI - PubMed
    1. Cheifetz AS, Gianotti R, Luber R, Gibson PR. Complementary and alternative medicines used by patients with inflammatory bowel diseases. Gastroenterology. 2017;152:415–429. doi: 10.1053/j.gastro.2016.10.004. - DOI - PubMed
    1. Cheung WY, Garratt AM, Russell IT, Williams JG. The UK IBDQ-a British version of the inflammatory bowel disease questionnaire: development and validation. J Clin Epidemiol. 2000;53:297–306. doi: 10.1016/S0895-4356(99)00152-3. - DOI - PubMed
    1. Cohen NA, Maharshak N. Novel indications for fecal microbial transplantation: update and review of the literature. Dig Dis Sci. 2017;62:1131–1145. doi: 10.1007/s10620-017-4535-9. - DOI - PubMed
    1. Doherty G, Bennett G, Patil S, Cheifetz A, Moss AC (2009) Interventions for prevention of post-operative recurrence of Crohn's disease. Cochrane Database Syst Rev 4: CD006873. - PubMed

Publication types

Substances

LinkOut - more resources