Irritable Bowel Syndrome Clinical Trial
Official title:
The Beneficial Effects of a Novel Formulation of Bifidobacterium Longum BB536 and Lactobacillus Rhamnosus HN001 With Vitamin B6 on Gut Microbiota and Intestinal Permeability in IBS Patients.
Irritable bowel syndrome (IBS) is one of the most frequent functional gastrointestinal disorder with a prevalence ranging from 10 to 15 percent. IBS results from an interaction among several factors, including genetic predisposition, gastrointestinal motility, visceral hypersensitivity, immune activation with minimal inflammation, alterations in intestinal microbiota, increased intestinal permeability, and food sensitivity. Of note, the management of patients with IBS is critical. Since quantitative and qualitative disturbances of intestinal microbiota can occur in IBS, interesting data support the use of probiotics to modulate intestinal microbiota. The present study aimed to investigate the effects of a novel formulation of B. longum BB536 and L. rhamnosus HN001 with vitamin B6 on the gut microbiota and intestinal permeability in IBS subjects.
Irritable bowel syndrome (IBS) is one of the most frequent functional gastrointestinal
disorder with a prevalence ranging from 10 to 15 percent. It is characterized by recurrent
chronic abdominal pain or discomfort in the absence of detectable organic causes with two or
more of the following conditions: onset associated with a change in frequency of stool, onset
associated with a change in form (appearance) of stool, or improvement with defecation.
IBS results from an interaction among several factors, including genetic predisposition,
gastrointestinal motility, visceral hypersensitivity, immune activation with minimal
inflammation, alterations in intestinal microbiota, increased intestinal permeability, and
food sensitivity.
IBS is associated with a high economic burden for the health care costs and work absenteeism.
The disease course is represented by unchanged symptoms in 30 to 50 percent or progression of
symptoms in 2 to 18 percent. On the other hand, an improvement in symptoms was recorded in 12
to 38 percent of patients.
Of note, the management of patients with IBS is critical. Several therapeutic options have
been proposed looking to the underlying pathophysiological mechanisms (i.e., dietary
modification, osmotic laxatives, lubiprostone, guanylate cyclase agonists,
5-hydroxytryptamine (serotonin) 4 receptor agonists, antidiarrheal agents, bile acid
sequestrants, 5-hydroxytryptamine (serotonin) 3 receptor antagonists, antispasmodic agents,
antidepressants, antibiotics, probiotics, behavior modification, anxiolytics, mast cell
stabilizer, and fecal transplantation).
Since quantitative and qualitative disturbances of intestinal microbiota can occur in IBS,
interesting data support the use of probiotics to modulate intestinal microbiota. The genus
Bifidobacterium is one of the most representative member of the intestinal microbiota with
large effects on overall gut physiology. Its metabolic activity results from the degradation
of oligo-fructose, production of acetate, and promotion of butyrate production by means of
cross-feeding. In particular, B. longum has beneficial effects on the immune system, and can
be considered a promising candidate for prevention/treatment of immune-mediated inflammatory
diseases.
The combination of specific bacterial strains of Lactobacillus with Bifidobacterium species
plays an interesting role in reserving the intestinal dysbiosis. The synergic action results
in survival on adverse gastrointestinal conditions, adhesion to intestinal mucosa,
immunomodulatory activities, and restoration of gut environment.
The present study aimed to investigate the effects of a novel formulation of B. longum BB536
and L. rhamnosus HN001 with vitamin B6 on the gut microbiota and intestinal permeability in
IBS subjects.
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