Manipulation of Visceral Hypersensitivity With Probiotic Bacteria in Irritable Bowel Syndrome
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome |
Dietary Supplement: VSL#3 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Manipulation of Visceral Hypersensitivity With Probiotic Bacteria in Irritable Bowel Syndrome |
- Clinical symptoms [ Time Frame: 4 weeks post probiotic ] [ Designated as safety issue: No ]
- Differences in gut microbiota between IBS patients and controls [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Difference in gut microbiota post probiotic in IBS patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Differences in blood and mucosal SERT polymorphisms between IBS patients and controls [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Rectal sensitivity [ Time Frame: 4 weeks post probiotics ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | July 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Siew C Ng, The Chinese Unviersity of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01139736 History of Changes |
| Other Study ID Numbers: | IBS Probiotics |
| Study First Received: | June 3, 2010 |
| Last Updated: | January 18, 2013 |
| Health Authority: | Hong Kong: Department of Health Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
Irritable bowel syndrome IBS probiotics |
rectal sensitivity gut flora gut bacteria |
Additional relevant MeSH terms:
|
Hypersensitivity Irritable Bowel Syndrome Immune System Diseases Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013