Open label probiotics trial and effects on anxiety/depression in irritable bowel syndrome (IBS) patients

Completed

• Conditions: Irritable bowel syndrome, associated anxiety and/or depression; Digestive System; Irritable bowel syndrome

• Registration Number: ISRCTN30654050
• Lead Sponsor: Yakult UK Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-12
• Study Completion: 2014-10-03
• Last Update Posted: 2 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged between 20 and 50 years, either sex
2. Diagnosis of IBS using Rome II Criteria and either moderate/severe anxiety and/or depression
3. Medication on stable dosage for at least 4 weeks before entry into the study
4. Demonstrates a full understanding of the study protocol and its requirements
5. Demonstrates willingness to take either trial probiotic or control placebo as required in the study protocol

Exclusion Criteria

1. Already taking regular probiotic supplement
2. No IBS
3. Has IBS but not moderate/severe anxiety or depression
4. Unstable medication
5. Lactose intolerance
6. Demonstrates difficulty in understanding study protocol requirements
7. Does not agree to take either trial probiotic or control placebo as required in the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified