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Completed

NCT Number: NCT03815617

A Novel Formulation of Bifidobacterium Longum BB536 and Lactobacillus Rhamnosus HN001 With Vitamin B6 on 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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica Medica "A. Murri", Department of Biomedical Sciences & Human Oncology, University of Bari Medical School

Bari, BA, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Zircombi

Dietary Supplement

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.

Placebo

Dietary Supplement

Given as comparable packets. Same duration.

Primary outcomes

  1. Visual Analogue Scale, ranging from 0 to 100

    Time frame: Baseline

    For assessing abdominal pain and bloating

  2. Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)

    Time frame: Baseline

    Developed by Francis et al. (1997), and categorized as follows: remission (score <75), mild (75-175), moderate (175-300) and severe (>300).

  3. Bristol Stool Form Scale (BSFS)

    Time frame: Baseline

    To assess bowel movements, consisting of a self-report instrument for classifying stool form into seven types ranging from "separate hard lumps like nuts" (type 1) to "watery, no solid pieces" (type 7)

  4. MEDSTYLE questionnaire

    Time frame: Baseline

    A custom-designed questionnaire, tested across different ages, and anthropometric groups in health and disease, to measure anthropometric data, medical history, lifestyle and daily intake of foods. Frequency (day, week or month) and portion sizes (small, medium and large, represented by color pictures) of food consumption were estimated by using 35 food items (156 foods).The adherence to a Mediterranean diet was calculated by analyzing nine food categories with a score ranging from 0 point (lowest adherence) to 18 points (highest adherence).

  5. Intestinal permeability

    Time frame: Baseline

    It was assessed by oral administration of four sugar probes, which selectively characterize the permeability from different tracts of the gastrointestinal system. Sucrose (SO) was used as a marker of gastro-duodenal permeability; lactulose (LA) and mannitol (MA) were used as markers of small intestine permeability also as (LA/MA), and sucralose (SU) as marker of

    8 colonic permeability.

  6. Cultivable intestinal microbiota

    Time frame: Baseline

    It was evaluated by faecal samples (5 g) were mixed with 45 mL sterilized physiological solution and homogenized.

  7. Community level catabolic profiles

    Time frame: Baseline

    Biolog Eco microplates (Biolog, Inc., Hayward, CA, USA) were used to estimate the microbial diversity.

  8. Fecal metabolome

    Time frame: Baseline

    Three grams of fecal sample were placed into 10 mL glass vials and added with 10 μL of 4-methyl- 2-pentanol (final concentration of 33 mg/L) as the internal standard.

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study 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.

Acronym: LLB

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2019
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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