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CompletedNCT01127828Updated May 24, 2010

Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes

An interventional study of Arla Yoghurt with no probiotic and Probiotic yoghurt (Cultura) in Irritable Bowel Syndrome, Relief of Irritable Bowel Syndrome Symptoms and Quality of Life, sponsored by Good Food Practice, Sweden. Completed at 1 site in Sweden. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-24.

Sponsored by Good Food Practice, Sweden · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

Recent research has shown taht probiotic may give positive effect on symptoms among patients with (IBS) Irritable Bowel Syndrome. The mechanism behind the positive effect are not known but a positive effect on different cytokines are a possible mechanism. Also effect on the large intestine bacterial mass could be of importance.

02

Conditions studied

  • Irritable Bowel Syndrome
  • Relief of Irritable Bowel Syndrome Symptoms
  • Quality of Life

Keywords

  • IBS (Irritable Bowel Syndrome)
  • Probiotic yoghurt
  • Symptom severity
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 80 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Good Food Practice, Sweden is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

-

Exclusion Criteria:

  1. Participation in a clinical study one month prior to screening visit and throughout the study.
  2. Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
  3. Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator.
  4. Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
  5. Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator.
  6. Severe psychiatric disease as judged by the investigator.
  7. Previous history of drug or alcohol abuse six months prior to screening.
  8. Intolerance or allergy against milk products or gluten.
  9. Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study.
  10. Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
  11. Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study.
  12. Pregnant or lactating or wish to become pregnant during the period of the study.
  13. Lack of suitability for participation in the study for any reason as judged by the investigator.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Probiotic yoghurt (Cultura)

    Cultura yoghurt containing: L bulgaricus, S thermophilus

    Other: Probiotic yoghurt (Cultura)

  • Placebo comparator
    Yoghurt with no probiotic

    Other: Arla Yoghurt with no probiotic

Interventions

  • OtherArla Yoghurt with no probiotic

    two servings of 200 ml of investigational products per day

  • OtherProbiotic yoghurt (Cultura)

    200 ml per day

06

What researchers measure

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

    Time frame: 6 weeks intervention and 6 weeks follow up

Secondary outcomes

  1. Effects on gastrointestinal and extraintestinal symptoms

    effects of the investigational products on GI and extraintestinal symptoms assessed with the weekly IBS SSI questionnaire and the scores from the daily questions of the GI symptom questionnaire as weel as the effect on psychological symptoms and quality of life.

    Time frame: September 2005 to May 2006

07

Study locations

1 site
  • Department of Internal Medicine, Sahlgrenska University Hospital
    Gothenburg, 41345, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01127828
Lead sponsor
Good Food Practice, Sweden
First posted
May 21, 2010
Start date
Sep 2005
Primary completion
May 2006
Completion
May 2006
Last update
May 24, 2010

Study contacts

Magnus Simrén, Ass Prof
principal investigator · Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
Magnus Simren, Ass prof.
principal investigator · Sahlgrenska hospital, Gothenburg, Sweden
Magnus Simrén, Ass proff
principal investigator · Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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