Effects of Activia in IBS (MOSAIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Sahlgrenska University Hospital, Sweden
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014