Simple Diverticular Disease Clinical Trial
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 Diverticular Disease of the Colon
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
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 play an important role in some pathologies of the
gastrointestinal tract, from Inflammatory Bowel Diseases (IBD) to Irritable Bowel Syndrome
(IBS). Most likely, it plays the same role in diverticular disease. In fact, the current
western diet is poor in fibers and can cause an alteration of the resident bacterial
species, with a reduction of bifidobacteria and an increase of clostridia.
This alteration might be present in diverticular disease and the manipulation of the
microbial flora might represent both a treatment option for diverticular disease and the
prevention of its complications.
Recent studies showed that the treatment with probiotics can help reduce the activity index
in patients with DDS and as well as reduce the recurrence of the disease.
A new method has now been validated to assess the microbiota: the analysis of the faecal and
urinary metabolome by high resolution Nuclear Magnetic Resonance (NMR) spectroscopy. The
microbioma is the combination of the DNA of the microorganisms that compose the intestinal
microflora (microbiota). Metabolomics allow to assess the metabolic activity of the
microbiota and its possible interactions with the host.
The metabolomic analyses of stools and urine offer a new approach to evaluate the metabolome
of diverticular disease, and compare it in patients who take a probiotic, fibers,
non-absorbable antibiotics or an anti-inflammatory drug.
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Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02314013 -
Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon
|
N/A |