Clinical trial NCT03815617: A Novel Formulation of Bifidobacterium Longum BB536 and Lactobacillus Rhamnosus HN001 With Vitamin B6 on IBS Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of IBS according to Rome IV Criteria

Exclusion Criteria:

* Diagnosis of structural abnormality of the GI tract
* Inflammatory bowel disorders
* Biliary duct obstructions
* Gallstones
* Abdominal surgery within the previous six months
* Infective diseases
* Drug or alcohol abuse
* Metabolic disturbances
* Mental illness
* Concomitant immunological, haematological or neoplastic disease
* Severe hepatic insufficiency (i.e., Child-Pugh class C)
* Severe heart failure (NYHA class III-IV)

Primary outcomes:
measure: Visual Analogue Scale, ranging from 0 to 100
timeFrame: Baseline
measure: Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
timeFrame: Baseline
measure: Bristol Stool Form Scale (BSFS)
timeFrame: Baseline
measure: MEDSTYLE questionnaire
timeFrame: Baseline
measure: Intestinal permeability
timeFrame: Baseline
measure: Cultivable intestinal microbiota
timeFrame: Baseline
measure: Community level catabolic profiles
timeFrame: Baseline
measure: Fecal metabolome
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Clinica Medica "A. Murri", Department of Biomedical Sciences & Human Oncology, University of Bari Medical School
state: BA
Study officials:
affiliation: Professor
name: Piero Portincasa
role: PRINCIPAL_INVESTIGATOR
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