Effects of Activia in IBS (MOSAIC)
This study is currently recruiting participants.
Verified May 2013 by Sahlgrenska University Hospital, Sweden
Sponsor:
Sahlgrenska University Hospital, Sweden
Collaborator:
Danone Research
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01252550
First received: December 2, 2010
Last updated: May 28, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to investigate the association between gut microbiota, immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge test in IBS patients.
| Condition | Intervention |
|---|---|
|
Irritable Bowel Syndrome |
Dietary Supplement: Activia® (125g/pot) Dietary Supplement: Acidified non-fermented dairy product |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Association Between GI Microbiota, Low-grade Inflammation and Classical Pathophysiological Factors in Patients With Irritable Bowel Syndrome (IBS) and Effect of the Consumption of Activia on GI Symptoms Provoked by a Lactulose Challenge Test in IBS Patients |
Resource links provided by NLM:
Further study details as provided by Sahlgrenska University Hospital, Sweden:
Primary Outcome Measures:
- IBS symptoms [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Activia®
Activia® (125g/pot)
|
Dietary Supplement: Activia® (125g/pot)
Activia® (125g/pot) - dairy product containing bacterial culture Acti Regularis®
|
|
Placebo Comparator: Acidified non-fermented dairy product
Acidified non-fermented dairy product (125g/pot)
|
Dietary Supplement: Acidified non-fermented dairy product
Acidified non-fermented dairy product (125g/pot)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Signed written informed consent
- Age: between 18 and 65 years old at baseline visit
- IBS according to the Rome III criteria
- Ability to understand and willingness to comply to the study procedures
Exclusion Criteria:
- Participation in another clinical study 1 month prior to screening visit and throughout the study
- Abnormal results on the screening laboratory tests clinically relevant for study participation
- Other gastrointestinal disease(s) explaining the patient's symptoms, as judged by the investigator
- Other severe disease(s) such as malignancy, severe heart disease, kidney disease or neurological disease
- Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, weight loss or fever
- Severe psychiatric disease
- Previous history of drug or alcohol abuse 6 months prior to screening
- Intolerance or allergy against milk products or gluten
- Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study
- Consumption of antibiotics 1 month prior to screening and throughout the study
- Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study
- Pregnant or lactating or wish to become pregnant during the period of the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252550
Locations
| Sweden | |
| Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Västra Götaland, Sweden, 41345 | |
| Contact: Magnus Simrén, Prof. MD. PhD. +46313421000 magnus.simren@medicine.gu.se | |
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Danone Research
More Information
No publications provided
| Responsible Party: | Magnus Simrén, Professor, Sahlgrenska University Hospital, Sweden |
| ClinicalTrials.gov Identifier: | NCT01252550 History of Changes |
| Other Study ID Numbers: | NU341 |
| Study First Received: | December 2, 2010 |
| Last Updated: | May 28, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Sahlgrenska University Hospital, Sweden:
|
IBS GI QOL Pathophysiology |
Gut microbiota Danone Activia Probiotics |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013