Irritable bowel syndrome, associated anxiety and/or depression Digestive System Irritable bowel syndrome
Conditions
Interventions
Eligible patients will be seen by a therapist trained in the study protocol. Over a 3-month patient recruitment period, 40 patients with a primary diagnosis of IBS will be assessed for IBS symptoms us
Sponsors
Yakult UK Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Beck Anxiety Inventory (16+ at baseline to determine moderate to severe anxiety) 2. Beck Depression Inventory (20+ at baseline to determine moderate to severe depression) The outcomes will be taken at baseline and again at 12 weeks. As a pilot study, no interim measures were felt necessary over this relatively short timescale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Irritable bowel syndrome measures using ROME-II Criteria 2. Acceptability of intervention (qualitative) The outcomes will be taken at baseline and again at 12 weeks. As a pilot study, no interim measures were felt necessary over this relatively short timescale. | — |
Countries
United Kingdom
Outcome results
None listed