Condition category
Digestive System
Date applied
31/05/2007
Date assigned
30/08/2007
Last edited
12/09/2013
Prospective/Retrospective
Retrospectively 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 Lesley Roberts

ORCID ID

Contact details

Department of Primary Care and General Practice
Primary Care and Clinical Sciences Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NU211

Study information

Scientific title

Acronym

Study hypothesis

Irritable Bowel Syndrome (IBS) is a functional bowel disorder in which abdominal pain or discomfort is associated with a change in bowel habit and features of disordered defaecation. IBS is the most common chronic gastrointestinal disorder. The prevalence of IBS in the West Midlands is about 10%, with about half of these patients consulting their General Practitioner (GP) for advice, reassurance or symptom management. IBS is not a life-threatening disease but significantly reduces the quality of life of patients. IBS can have multiple causes and a wide range of symptoms. Symptoms vary greatly between individuals and this makes management of IBS difficult. For the patient, IBS can mean a substantial number of GP visits, prescriptions, tests and days off work, which is important in terms of cost to both the health service and the patient.

Hypothesis:
To determine the effect of consumption of probiotic yoghurt compared with non-probiotic yoghurt on symptoms of IBS and quality of life in patients with constipation predominant IBS.

Ethics approval

Approval received from the Nottingham Local Research Ethics Committee 2 on the 26th January 2007 (ref: 06/Q2404/172).

Study design

A multicentre, double blind randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Irritable Bowel Syndrome (IBS)

Intervention

1. Intervention group: receive two daily servings of a probiotic yoghurt which contains live strains of bacteria
2. Control group: receive two daily servings of a yoghurt that does not contain probiotic bacteria

The total duration of the study is 14 weeks, which includes two weeks of completing a daily diary only, followed by 12 weeks of eating two yoghurts daily and completing a daily diary. Participants will meet with a researcher on four occasions.

Intervention type

Drug

Phase

Not Specified

Drug names

Probiotic yoghurt

Primary outcome measures

The primary outcome measure is the effect on Subjects' Global Assessment (SGA) of IBS symptoms relief at four weeks

Secondary outcome measures

1. Effect on SGA of IBS symptoms relief over 12 weeks and per week
2. Effect on bloating, abdominal pain and flatulence/passage of gas over 4 and 12 weeks and per week
3. Effect on composite score of IBS symptoms (sum of severity score of bloating, abdominal pain and flatulence/passage of gas) over 4 and 12 weeks and per week
4. Effect on bowel function (stool frequency and consistency, bowel movement difficulty) over 4 and 12 weeks and per week
5. Effect on quality of life (IBS-QOL) after 4, 8 and 12 weeks
6. Effect on severity of IBS (IBS-SSS) after 4, 8 and 12 weeks
7. Effect on IBS specific symptoms questionnaire (pain, constipation and diarrhoea) after 4, 8 and 12 weeks
8. Effect on responders rate for SGA of IBS symptoms relief over 1 - 4 weeks and 1 - 12 weeks period (a responder will be defined as a patient who reported satisfactory relief on at least 50% of weeks of the considered period)
9. Effect on responders rate for bloating severity at 4 weeks and 12 weeks (a responder will be defined as a patient who reported at least a 50% decrease of bloating severity at 4 or 12 weeks)

Overall trial start date

01/01/2007

Overall trial end date

30/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female or male free-living patients aged from 18 to 65 years
2. Patient with a diagnosis of IBS according to Rome III criteria: recurrent abdominal pain or discomfort at least three days per month in the last three months associated with two or more of the following:
2.1. Improvement with defaecation
2.2. Onset associated with a change in frequency of stool
2.3. Onset associated with a change in form (appearance) of stool
3. Patient with a diagnosis of IBS according to Rome III criteria with symptom onset at least six months prior to diagnosis
4. Patient with constipation-predominant symptom profile according to Rome III criteria: hard or lumpy stools (type 1 - 2 of Bristol scale) greater than 25% and loose (mushy) or watery stools (type 6 - 7 of Bristol scale) less than 25% of bowel movement
5. Patient having an Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score greater than 75
6. Patient passing three or less stools per day during baseline data gathering phase

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Patient with a diagnosis of IBS with diarrhoea-predominant, mixed and unsubtyped according to Rome III criteria: loose (mushy) or watery-type 6-7 of Bristol scale) stools greater than 25% and hard or lumpy (type 1-2 of Bristol scale) stools less than 25% of bowel movement
2. Patient with a diagnosis of IBS with clinical signs of alarm (rectorragy, fever, associated inflammatory articular signs, recent weight loss)
3. Commencement of an anti-psychotic medication within the prior month
4. Change of prescribing for IBS-symptoms within the prior month
5. Change of dietary habit within the preceding month
6. Patient with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
7. Patient undergoing general anaesthesia in the month prior to inclusion
8. For female patient:
8.1. Pregnant patient or patient planning to become pregnant during the study
8.2. Breast-feeding
9. Patient currently involved in any other clinical trial or having participated in a trial for IBS within the preceding three months
10. Patient with known lactose intolerance or immunodeficiency
11. Patient with known allergy to product component (milk protein for example)
12. Patients who are morbidly obese (Body Mass Index [BMI] greater than 35) or where BMI is less than 18 (as this will be deemed suggestive of abnormal diet or function)
13. Patients with history of laxative abuse

Recruitment start date

01/01/2007

Recruitment end date

30/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care and General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Danone Research (France)

Sponsor details

c/o Nicolas Gausseres
Route Departementale 128
Paris
91767
France

Sponsor type

Industry

Website

http://www.danone.com/

Funders

Funder type

Industry

Funder name

Groupe Danone (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23496803

Publication citations

  1. Results

    Roberts LM, McCahon D, Holder R, Wilson S, Hobbs FD, A randomised controlled trial of a probiotic 'functional food' in the management of irritable bowel syndrome., BMC Gastroenterol, 2013, 13, 45, doi: 10.1186/1471-230X-13-45.

Additional files

Editorial Notes