A double-blind, randomised study on the effects of STW 5 on symptoms and immunologic function in patients with irritable bowel syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12609000085279
• Lead Sponsor: Royal Adelaide Hospital Gastroenterology and Hepatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Symptoms consitent with IBS according to the Rome III criteria; Not recieved antibiotics 8 wks prior; Not taking immunosuppressive medications;No Laxatives, no prokinetic drugs for 2 weeks;
Able to sign consent

Exclusion Criteria

Previous abdominal or gynaecological surgery (except appendectomies and cholecystectomies) previous gastrointestinal cancer;Known peptic ulcers;pregnancy or breastfeeding;chronic inflammatory disease, cardiovascular disease; respiratory disease;Diabetes mellitus; Epilepsy;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the improvement of symptoms in patients with IBS during treatment with the herbal preparation, Iberogast (STW 5) and placebo the subject will complete previously standardised questionnaires[Visit 1 baseline, visit 2 week 2, visit 3 week 4, visit 4 week 5, visit 5 week 7.]

Secondary Outcome Measures

Name	Time	Method
Through analysis subjects blood sample at visit 1,3,4 and 5 we will measure the influence of the treatment on Peripheral Blood Monouclear cell (PBMC)-mediated cytokine secretion and gut homing T cells.[Visit 1 baseline, visit 3 week 4, visit 4 week 5, visit 5 week 7]