A Novel Formulation of Bifidobacterium Longum BB536 and Lactobacillus Rhamnosus HN001 With Vitamin B6 on IBS Patients
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Zircombi; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Twenty-five IBS patients (Rome IV criteria) (M:F= 8:17; age 48 yrs ± 11 SD) were enrolled and randomized to treatment or placebo in a a crossover randomized double-blind two-block placebo-controlled trial. Abdominal pain and bloating, intestinal habits, severity of disease, intestinal permeability, and intestinal microbiota were performed at the different time points.; Given as comparable packets. Same duration.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients entered the following program:
A run-in period of one month when symptoms, intestinal permeability, intestinal microbiota, and dietary evaluations were performed;
Phase 1: randomization to treatment or placebo lasting 30 days;
Wash-out period lasting 15 days, at the end of which symptoms were assessed;
Phase 2: switch to next treatment in a crossover fashion. Treatment lasted for 30 days and at the end symptoms, intestinal permeability, and intestinal microbiota were evaluated again.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IBS