Irritable Bowel Syndrome (IBS) Digestive System Diseases of intestines
Conditions
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 probiot
Sponsors
Danone Research (France)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the effect on Subjects' Global Assessment (SGA) of IBS symptoms relief at four weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Outcome results
None listed