Effect of the consumption of a fermented dairy product on digestive symptoms and quality of life in patients with irritable bowel syndrome

Completed

• Conditions: Irritable Bowel Syndrome (IBS); Digestive System; Diseases of intestines

• Registration Number: ISRCTN78863629
• Lead Sponsor: Danone Research (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified