Open label probiotics trial and effects on anxiety/depression in irritable bowel syndrome (IBS) patients
| ISRCTN | ISRCTN30654050 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30654050 |
| EudraCT/CTIS number | 2014-001854-40 |
| Secondary identifying numbers | R16767 |
- Submission date
- 15/08/2008
- Registration date
- 12/09/2008
- Last edited
- 06/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rod Lambert
Scientific
Scientific
School of Allied Health Professions
University of East Anglia
Earlham Road
Norwich
NR4 7TJ
United Kingdom
Study information
| Study design | A pilot study, open label, placebo controlled, non-randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A pilot study, open label, placebo controlled, non-randomised trial of the influence of Lactobacillus Shirota on anxiety and depression in patients with irritable bowel syndrome (IBS) |
| Study objectives | Can regular daily consumption of 2 x 65 ml bottles of a probiotic drink (Yakult containing Lactobacillus Shirota) by patients diagnosed with irritable bowel syndrome (IBS) and moderate to severe anxiety and/or depression, have a therapeutic effect on both symptoms of IBS and anxiety/depression in conjunction with routine General Practitioner (GP) care? |
| Ethics approval(s) | REC Yorkshire and The Humber - Sheffield, 16/06/2014, ref: 14/YH/0176 |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome, associated anxiety and/or depression |
| Intervention | 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 using the ROME II Criteria, anxiety (using the Beck Anxiety Inventory) and depression (using the Beck Depression Inventory II), at baseline and again at the end of a 3-month trial. During the trial, patients in the trial arm will be provided with routine GP care plus a fortnightly supply of 65 ml bottles of Yakult probiotic drink containing Lactobacillus Shirota sufficient for two bottles per day over the 3-month period. This will be sent direct to either the GP Practice or the Clinical Research and Trials Unit at UEA, dependent upon the patient's preference, by Yakult for collection by the patient. The control arm will be provided with routine GP care plus a fortnightly supply of a Longlife Milk Shake. If they were taking medication at the beginning of the trial, this would have been at a stable dose for at least 4 weeks before entry into the trial. Trial and control arm patients will be selected from different GP Practices participating in the trial to minimise cross-over and contamination of information between patients. At the end of the 3-month trial, each patient in both study arms will be asked to complete the outcome measures again and will be asked if they have been given information from any source outside the trial about probiotic supplementation. |
| Intervention type | Supplement |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 06/10/2008 |
| Completion date | 03/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 referrals, 40 to final analysis (30 trial arm, 10 control arm) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/10/2008 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
NR4 7TJ
United Kingdom
Sponsor information
Yakult UK Ltd (UK)
Industry
Industry
c/o Dr Linda Thomas, UK Science Manager
Artemus
Odyssey Business Park
West End Road
Ruislip, Middlesex
HA4 6QE
United Kingdom
"ROR" |
https://ror.org/03wmnrc91 |
|---|
Funders
Funder type
Industry
Yakult UK Ltd (UK) (ref: R16767)
No information available
Results and Publications
| Intention to publish date | 03/10/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in Pharmaceutical Science Journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/06/2018: No publications found, verifying study status with principal investigator.
20/05/2016: The overall trial end date has been updated from 30/09/2009 to 03/10/2014. In addition, the ethics approval information and availability of the participant level data have been added.
09/05/2016: No publications found, verifying study status with principal investigator.
