Effect of CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial.

Cesare Cremon, Simone Guglielmetti, Giorgio Gargari, Valentina Taverniti, Anna Maria Castellazzi, Chiara Valsecchi, Carlotta Tagliacarne, Walter Fiore, Massimo Bellini, Lorenzo Bertani, Dario Gambaccini, Michele Cicala, Bastianello Germanà, Maurizio Vecchi, Isabella Pagano, Maria Raffaella Barbaro, Lara Bellacosa, Vincenzo Stanghellini, Giovanni Barbara

Journal: United European gastroenterology journal 2017;6(4):604-613

PMID: 29881616

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Plain Language Summary

Intestinal bacteria have a role to play in the development and symptoms of irritable bowel syndrome (IBS). The objective of this randomised controlled trial was to assess the effects of Lactobacillus paracasei CNCM I-1572 on clinical and gut microbiota-related factors in IBS. Forty IBS patients took part in the trial, and took either the probiotic or a placebo for four weeks. Lactobacillus paracasei CNCM I-1572 did not significantly improve IBS symptoms such as abdominal pain and discomfort. It did however induce a significant reduction in Ruminococcus, which has previously been associated with IBS. Patients taking the probiotic also showed a significant increase in the short chain fatty acids (SCFAs) acetate and butyrate, and a significant reduction in the pro-inflammatory cytokine interleukin-15. This pilot study shows that Lactobacillus paracasei CNCM I-1572 is able to modulate gut microbiota structure/function and reduce immune activation in IBS. As no statistically significant effect on IBS symptoms was found, further studies are necessary to determine the role of this probiotic in IBS.

Abstract

BACKGROUND

Evidence suggests a role of intestinal microbiota-host interactions in the pathophysiology and symptoms of irritable bowel syndrome (IBS).

OBJECTIVE

The objective of this article is to assess the effects of CNCM I-1572 on clinical and gut microbiota-related factors in IBS.

METHODS

We conducted a multicenter, randomized, double-blind, cross-over, 18-week, placebo-controlled, pilot trial assessing the effect of CNCM I-1572 on symptoms, gut microbiota composition, fecal short chain fatty acid (SCFA), immunoglobulin A, and cytokines in IBS. The intestinal microbial ecosystem was characterized by 16S rRNA gene profiling.

RESULTS

Forty IBS patients were enrolled from five Italian centers. CNCM I-1572 did not significantly improve IBS symptoms, including primary efficacy variables worst abdominal pain/discomfort and IBS degree of relief. Interestingly, CNCM I-1572 induced a significant reduction in genus , dominated by taxa related to and , a significant increase in the SCFAs acetate and butyrate, and a significant reduction in the pro-inflammatory cytokine interleukin-15.

CONCLUSIONS

This pilot study shows that CNCM I-1572 is able to modulate gut microbiota structure/function and reduce immune activation in IBS. As no statistically significant effect on IBS-symptoms was found, further studies are necessary to determine the role of this probiotic in IBS. The study was registered at ClinicalTrials.gov registry under identifier NCT02371499.

Address: Department of Medical and Surgical Sciences, Centre for Applied Biomedical Research, University of Bologna, Bologna, Italy.; Department of Food, Environmental and Nutritional Sciences, Division of Food Microbiology and Bioprocesses, University of Milan, Milan, Italy.; Department of Clinical Surgical Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.; 4Sofar S.p.A., Trezzano Rosa, Italy.; Gastroenterology Unit, Department of Gastroenterology, University of Pisa, Pisa, Italy.; Gastroenterology Unit, University Campus Bio-Medico of Rome, Rome, Italy.; Gastroenterology Unit, S. Martino Hospital, Belluno, Italy.; 8Gastroenterology and Digestive Endoscopy Unit, IRCCS Policlinico San Donato, San Donato Milanese, Italy.

DOI: 10.1177/2050640617736478