NCT01127828

Brief Summary

To determine the effect of cultura probiotic yoghurt on number of responders to treatment during 8 weeks of treatment in comparison to placebo. To determine the effect of cultura yoghurt on change in total score of (IBS) irritable bowel syndrome severity index during 8 weeks of treatment in comparison to placebo in IBS out patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
Last Updated

May 24, 2010

Status Verified

May 1, 2010

Enrollment Period

8 months

First QC Date

May 20, 2010

Last Update Submit

May 21, 2010

Conditions

Irritable Bowel SyndromeRelief of Irritable Bowel Syndrome SymptomsQuality of Life

Keywords

IBS (Irritable Bowel Syndrome)Probiotic yoghurtSymptom severity

Outcome Measures

Primary Outcomes (1)

  • Relief of IBS symptoms

    The primary endpoint of this study was the proportions of patients reporting adequate relief of their IBS symptoms at least 50 % of the weeks during the treatment period

    6 weeks intervention and 6 weeks follow up

Secondary Outcomes (1)

  • Effects on gastrointestinal and extraintestinal symptoms

    September 2005 to May 2006

Study Arms (2)

Probiotic yoghurt (Cultura)

ACTIVE COMPARATOR

Cultura yoghurt containing: L bulgaricus, S thermophilus

Other: Probiotic yoghurt (Cultura)

Yoghurt with no probiotic

PLACEBO COMPARATOR
Other: Arla Yoghurt with no probiotic

Interventions

Arla Yoghurt with no probioticOTHER

two servings of 200 ml of investigational products per day

Yoghurt with no probiotic
Probiotic yoghurt (Cultura)OTHER

200 ml per day

Probiotic yoghurt (Cultura)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed consent to participate age 18-70 years IBS according to Rome II criteria

You may not qualify if:

  • Participation in a clinical study one month prior to screening visit and throughout the study.
  • Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
  • Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator.
  • Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
  • Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator.
  • Severe psychiatric disease as judged by the investigator.
  • Previous history of drug or alcohol abuse six 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 antibiotic drugs 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.
  • Lack of suitability for participation in the study for any reason as judged by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Magnus Simrén, Ass Prof

    Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

  • Magnus Simren, Ass prof.

    Sahlgrenska hospital, Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

  • Magnus Simrén, Ass proff

    Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 21, 2010

Study Start

September 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

May 24, 2010

Record last verified: 2010-05

Locations

SE(1)