Additional identifiers
EudraCT number
2014-001854-40
ClinicalTrials.gov number
Protocol/serial number
R16767
Study information
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)
Acronym
Study hypothesis
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
REC Yorkshire and The Humber - Sheffield, 16/06/2014, ref: 14/YH/0176
Study design
A pilot study, open label, placebo controlled, non-randomised trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
06/10/2008
Overall trial end date
03/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 referrals, 40 to final analysis (30 trial arm, 10 control arm)
Participant 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
Recruitment start date
06/10/2008
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
Funders
Funder type
Industry
Funder name
Yakult UK Ltd (UK) (ref: R16767)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in Pharmaceutical Science Journal.
Intention to publish date
03/10/2017
Participant level data
Available on request
Basic results (scientific)
Publication list