Manipulation of Visceral Hypersensitivity With Probiotic Bacteria in Irritable Bowel Syndrome

NCT01139736 | Completed Phase 4

• 1 other identifier: IBS Probiotics
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome is a common digestive disorder worldwide. However, there is no effective treatment of irritable bowel syndrome. Visceral pain thresholds in response to stress are lower in patients with IBS compared to healthy volunteers, but the triggers to visceral hypersensitivity remain largely unknown. Animal models suggest roles for both host immune response and intestinal bacteria in the induction of visceral hypersensitivity. For instance colorectal distension increased in association with an alteration in bacterial flora induced by antibiotic therapy, which suggest a relationship between bacterial gut content and visceral afferent processing. Intestinal bacteria play a significant role in inducing IBS. Clinical studies have shown that manipulation of the commensal microbiota with probiotic bacteria, in particularly preparations that contain bifidobacteria, can alleviate IBS symptoms. Serotonin (5-HT) plays a crucial role in the regulation of gastrointestinal physiology and alterations in mucosal serotonin signaling is a possible mechanism of altered function and sensation in patients with IBS. Impairment of serotonin reuptake transporter (SERT) expression and function may also play a role in IBS. The investigators hypothesise that bacteria modulate sensory afferent and serotonin signaling necessary for visceral sensation and that these pathways can be targeted for therapy of IBS using probiotic bacteria. The first part of this study will be a cross-sectional study comparing the colonic microbiota and SERT polymorphisms in IBS patients and healthy controls. The second part will be an open-label pilot study to assess the effects of oral probiotic bacteria in visceral hypersensitivity and mucosal microbiota in patients with IBS. Clinical response will be assessed based on IBS symptom score and rectal sensitivity, and changes in mucosa microbiota will be measured using 454 pyrosequencing. This proposal will provide novel data on gut microbiota in Asian IBS patients, and explore the mechanisms underlying visceral hypersensitivity to direct future targeting of therapy in IBS.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome; IBS; probiotics; rectal sensitivity; gut flora; gut bacteria

Outcome Measures

Primary Outcomes (1)

• Clinical symptoms

  4 weeks post probiotic

Secondary Outcomes (4)

• Differences in gut microbiota between IBS patients and controls

  1 year

• Difference in gut microbiota post probiotic in IBS patients

  1 year

• Differences in blood and mucosal SERT polymorphisms between IBS patients and controls

  1 year

• Rectal sensitivity

  4 weeks post probiotics

Study Arms (1)

Probiotics

EXPERIMENTAL

IBS Patients will receive VSL#3 (450 billion lyophilized bacteria/sachet) twice daily for 4 weeks. VSL#3 was selected for use in this study because (a) it contains three different Bifidobacteria strains (in addition to lactobacilli and streptococci) and the limited evidence available Bifidobacteria as the most effective probiotics in IBS .

Dietary Supplement: VSL#3

Interventions

VSL#3 DIETARY_SUPPLEMENT

IBS Patients will receive VSL#3 (450 billion lyophilized bacteria/sachet) twice daily for 4 weeks

Probiotics

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Symptoms of abdominal pain or discomfort of at least 3 times a month, in the last 6 months, associated with 2 or more of the following:
• Improvement with defecation
• Onset associated with a change in frequency of stool
• Onset associated with a change in form (appearance) of stool

You may not qualify if:

• history of weight loss or rectal bleeding
• history of psychiatric illness (severe depression, mania and schizophrenia)
• history of active infection
• recent antibiotic therapy or anti-inflammatory medication

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Siew C Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 9, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 21, 2013

Record last verified: 2011-02

Locations

HK (1)