Manipulation of Visceral Sensitivity and Immune System in IBS

NCT00418340 | Unknown Phase 4

• 1 other identifier: 07.IBS.1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is a common condition. At least 20% of the population suffer from IBS. The symptoms of abdominal pain, diarrhoea, constipation, bloating and difficulty with bowel motions are often disabling. Many of those affected are young and report a poor quality of life (QOL) to a degree that is similar to gut inflammatory conditions like ulcerative colitis and Crohn's disease. Yet the impact of IBS on patients' lives is often underestimated. This is probably because unlike inflammatory bowel disease, in which the bowel is inflammed and bleeds, the bowel in IBS looks normal. Instead the problem is of abnormal functioning of the gut the cause of which is unknown. Currently therapy for IBS is limited and until recently therapy has focused on treating the symptoms to improve QOL primarily because the underlying mechanism of IBS is poorly understood. However as more processes are being implicated in IBS e.g. visceral hypersensitivity (excessive response to sensory stimuli within the gut), infection, immune activation, dysmotility and abnormal gut fermentation , the potential for new therapies looks promising. The evidence that gut bacteria play a role in inducing IBS symptoms is due to observations of an improvement of IBS symptoms with probiotic therapy (bacterial supplements) and antibiotic therapy. Patients with IBS are hypersensitive to colorectal distension compared with healthy controls. Studies carried out in our unit have shown that visceral pain thresholds in response to stress are lower in patients with IBS compared with healthy volunteers. This hypersensitivity is apparent in response to both a physical and chemical stimulus 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. This proposal will focus on further exploration of the mechanisms underlying visceral hypersensitivity to direct future targeting of therapy. Previous independent studies showed that (a) bacteria reduce visceral hypersensitivity, (b)probiotic therapy can alter gut immune response and (c) gut sensation is affected by the type of immune cells in the gut. Our research proposal will investigate the relationship between gut bacteria, the immune system and the sensory gut nerves in order to understand how IBS symptoms are generated. This understanding will be the critical for effective future drug treatment.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome,; Visceral hypersensitivity,; probiotic therapy,; immune response

Outcome Measures

Primary Outcomes (2)

• The primary outcome measure is the change in physiological rectal sensitivity and before and after probiotic

• therapy.

Secondary Outcomes (2)

• Secondary outcome measures are the change symptoms and QOL induced by probiotic therapy and the

• change in the immune response after probiotic therapy.

Interventions

probiotic (bacterial/dietary supplement) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients fulfilling the Rome II criteria for the diagnosis of IBS
• normal blood investigations
• normal colonoscopy

You may not qualify if:

• a history of weight loss
• rectal bleeding
• fevers
• psychiatric illness (severe depression, anxiety, mania and schizophrenia)
• active infection
• recent antibiotic therapy or anti-inflammatory medication within previous 4 weeks

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

North West London Hospitals NHS Trust - St Mark's

London, Middlesex, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Probiotics; Dietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Naila Arebi, MD, PhD, MRCP

  London North West Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naila Arebi, MD,PhD, MRCP

CONTACT

020 8235; n.arebi@doctors.org.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: December 1, 2007
• Last Updated: November 16, 2007

Record last verified: 2007-11

Locations

GB (1)