Condition category
Digestive System
Date applied
15/08/2008
Date assigned
12/09/2008
Last edited
20/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rod Lambert

ORCID ID

Contact details

School of Allied Health Professions
University of East Anglia
Earlham Road
Norwich
NR4 7TJ
United Kingdom

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

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Drug

Phase

Not Specified

Drug names

Probiotic drink (Yakult containing Lactobacillus Shirota)

Primary outcome measures

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

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

School of Allied Health Professions
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

Yakult UK Ltd (UK)

Sponsor details

c/o Dr Linda Thomas
UK Science Manager
Artemus
Odyssey Business Park
West End Road
Ruislip
Middlesex
HA4 6QE
United Kingdom

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.