Clinical Trial: Evaluation of the Metabolome in Diverticular Disease

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Evaluation of the Metabolome in Diverticular Disease and Effects of Probiotic Mixture VSL#3 vs Fibers, Rifaximin and Mesalazine on the Metabolome in

Brief Summary: To evaluate the effect of the probiotic formulation VSL#3 on the metabolome and microbiota of diverticular disease, comparing it with the effects exerted by supplementation with fibers, by rifaximin and by mesalazine, and assessing the evolution over time after each specific treatment

Detailed Summary:

The incidence of diverticular disease of the colon has increased over the last few years. Since it presents potentially severe complications (both in terms of morbidity and mortality), the most recent studies are focusing on the underlying mechanisms and therapeutic options.

Diverticular disease of the colon presents important etiopathogenetic events. The first is that the severity of microscopic inflammation is correlated to the disease activity. The second is the bacterial overgrowth which is observed in the colon, where the diverticula form "recesses" where bacteria can proliferate. The third is that the "metabolome" plays an important role in the pathogenesis of diseases of the gastrointestinal tract (and not only). An extensive combination of microbial species live permanently in the human gut and participate in the metabolic activities of the gastro-intestinal tract (such as the synthesis of certain vitamins, improvement of the immune system, and balance of the resident bacterial species). There is little published clinical evidence suggesting a direct link between microbiota and diverticular disease; however, an altered microbiota in the flora of patients with colon cancer, irritable bowel syndrome, and IBD has been described.

It is clear that human metabolism and inflammatory response are influenced by genetic information outside our genome. Insights into the influence of microorganisms on the pathogenesis in gastrointestinal function and diverticular disease are in their infancy and often rely on extrapolation from other disease states. Microbiological analysis of fecal microbiota can provide important information on the role that the microbial-mammalian axis might have on the pathogenesis of diverticular disease.

Alteration of the metabolome pl
Sponsor: S.Eugenio Hospital

Current Primary Outcome:

• identify the metabolome of symptomatic uncomplicated Diverticular Disease (SUDD) [ Time Frame: 12 months ]
  As no studies have ever been conducted or published on this aspect, the main outcome of the study is to analyze and identify the metabolome of patients with SUDD before starting any therapy and after a 2 week therapy of a probiotic, fibers or antibiotics. The metabolomic analysis will allow a precise evaluation of the systemic and organ-specific processes based on low molecular weight components thus providing a profile of the metabolic system of these patients.
• verify changes in the intestinal microbiota following treatment in the different study groups. [ Time Frame: 12 months ]

Original Primary Outcome: identify the metabolome of symptomatic uncomplicated Diverticular Disease (SUDD) [ Time Frame: 12 months ]

Current Secondary Outcome:

• evaluate the symptomatology and metabolome [ Time Frame: 12 months ]
  Evaluate the difference in symptomatology in the different groups, in particular stool frequency, abdominal pain, mucus or blood in faeces, intestinal gas, and assess possible link to the different metabolome and microbiota
• evaluate the different metabolomes and microbiota according to the treatment used [ Time Frame: 12 months ]
  Evaluate if the variation in metabolome and microbiota induced by the different treatments modify the symptomatology of the patients and for how long.
• Evaluate the effects of supplementation with VSL#3 on the metabolome and microbiota of Diverticular Disease [ Time Frame: 12 months ]
  Evaluate the effects of supplementation with VSL#3 on the metabolome and microbiota of Diverticular Disease, comparing it with the effects of supplementation with fibers, or treatment with rifaximin or with mesalazine.
• evaluate if difference in the symptomatology in the different groups are correlated with changes in the intestinal microbiota [ Time Frame: 12 months ]

Original Secondary Outcome:

• evaluate the symptomatology and metabolome [ Time Frame: 12 months ]
  Evaluate the difference in symptomatology in the different groups, in particular stool frequency, abdominal pain, mucus or blood in faeces, intestinal gas, and assess possible link to the different metabolome
• evaluate the different metabolomes according to the treatment used [ Time Frame: 12 months ]
  Evaluate if the variation in metabolome induced by the different treatments modify the symptomatology of the patients and for how long.
• Evaluate the effects of supplementation with VSL#3 on the metabolome of Diverticular Disease [ Time Frame: 12 months ]
  Evaluate the effects of supplementation with VSL#3 on the metabolome of Diverticular Disease, comparing it with the effects of supplementation with fibers, or treatment with rifaximin or with mesalazine.

Dates:
Date Received: December 4, 2012
Date Started: December 2012
Date Completion: May 2015
Last Updated: October 16, 2014
Last Verified: October 2014