Manipulation of Visceral Hypersensitivity With Probiotic Bacteria in Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01139736
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : January 21, 2013
Information provided by:
Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: VSL#3 Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Manipulation of Visceral Hypersensitivity With Probiotic Bacteria in Irritable Bowel Syndrome
Study Start Date : July 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Probiotics
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
IBS Patients will receive VSL#3 (450 billion lyophilized bacteria/sachet) twice daily for 4 weeks

Primary Outcome Measures :
  1. Clinical symptoms [ Time Frame: 4 weeks post probiotic ]

Secondary Outcome Measures :
  1. Differences in gut microbiota between IBS patients and controls [ Time Frame: 1 year ]
  2. Difference in gut microbiota post probiotic in IBS patients [ Time Frame: 1 year ]
  3. Differences in blood and mucosal SERT polymorphisms between IBS patients and controls [ Time Frame: 1 year ]
  4. Rectal sensitivity [ Time Frame: 4 weeks post probiotics ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01139736

Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Siew C Ng, PhD Chinese University of Hong Kong

Additional Information:
Responsible Party: Dr Siew C Ng, The Chinese Unviersity of Hong Kong Identifier: NCT01139736     History of Changes
Other Study ID Numbers: IBS Probiotics
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: February 2011

Keywords provided by Chinese University of Hong Kong:
Irritable bowel syndrome
rectal sensitivity
gut flora
gut bacteria

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Immune System Diseases