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Effects of Activia in IBS (MOSAIC)

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ClinicalTrials.gov Identifier: NCT01252550
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : November 18, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Irritable Bowel Syndrome Dietary Supplement: Activia® (125g/pot) Dietary Supplement: Acidified non-fermented dairy product

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2010
Primary Completion Date : May 2014
Study Completion Date : August 2014
Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. IBS symptoms [ Time Frame: 8 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252550


Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, Västra Götaland, Sweden, 41345
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, S413-45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Danone Research
Investigators
Principal Investigator: Magnus Simrén, MD, PhD Sahlgrenska University Hospital, Sweden
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Magnus Simrén, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01252550     History of Changes
Other Study ID Numbers: NU341
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Magnus Simrén, Sahlgrenska University Hospital, Sweden:
IBS
GI
QOL
Pathophysiology
Gut microbiota
Danone
Activia
Probiotics

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases