Assessment of the probiotic symprove as a dietary supplement in patients with irritable bowel syndrome

Completed

Conditions: Irritable bowel syndrome
Digestive System

Registration Number: ISRCTN77512412

Lead Sponsor: Kings College Hospital (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 186

Inclusion Criteria

1. Aged between 18 - 65 years, either sex
2. A firm diagnosis of IBS (ROME III criteria)
3. Moderate to severe symptoms

Exclusion Criteria

1. Diagnosis of inflammatory bowel disease or other organic bowel disease
2. Significant co-morbidity
3. Major psychological disorders
4. Previous/current history of alcohol or drug dependence
5. Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 22/10/2013:<br>1. Efficacy ? change in IBS Symptom Severity Score (IBS-SSS) from baseline to week 12<br>2. Safety ? tolerability of the multistrain probiotic<br>The above change in protocol was made prior to the trial opening<br><br>Previous primary outcome measures:<br>Improvement in quality of life (QOL) as measured by a validated QOL questionnaire on week 12 of the study

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 22/10/2013:<br>Improvements in symptoms and QoL as described by:<br>1. Change in IBS-QoL score from baseline to week 12<br>2. Change in IBS-SSS component scores at week 12 <br>3. Changes in IBS-SSS and QoL between week 12 and 16<br>The above change in protocol was made prior to the trial opening<br><br>Previous secondary outcome measures:<br>1. Improvement in Sleep Quality Assessment<br>2. Improvement in Global Symptom Severity Score and specific symptom sub-scores (abdominal pain, bloating, stool frequency and stool consistency) <br>These will all be assessed at 4 weekly intervals (4, 8 and 12 weeks of treatment and week 16 - 4 weeks after treatment)