Probiotics - Clinical trial details 

Recruitment status:

Not Recruiting

Primary Sponsor:

Danone Research (France)

Recruitment countries:

United Kingdom

Health condition studied:

Irritable Bowel Syndrome (IBS)
Digestive System
Diseases of intestines

URL:

Link to the clinical trial website

About the trial

Interventions:

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.

Key inclusion and exclusion criteria:

• 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
• 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

• Age minimum: 
• Age maximum: 
• Gender:  Both

Primary outcomes:

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

Secondary outcomes:

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)

Target sample size:

240

Study type:

Interventional

Study design:

A multicentre, double blind randomised controlled study (Quality of life)

Contacts:

• Name:  
• Address: 
• Phone: 
• Email: 
• Affiliation: 

• Name: Lesley Roberts
• Address:  Department of Primary Care and General Practice Primary Care and Clinical Sciences Building University of Birmingham Edgbaston
• Phone: 
• Email: 
• Affiliation: 

Technical details

Scientific title:

Sources of monetary support:

Groupe Danone (France)

Secondary sponsors:

Main ID:

ISRCTN78863629

Secondary ID:

NU211

Register:

ISRCTN

Date of registration:

30/08/2007

Date of first enrollment:

01/01/2007

Last refreshed:

13 January 2015