Irritable Bowel SyndromeNCT01127828
Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes
A study testing Arla Yoghurt with no probiotic and Probiotic yoghurt (Cultura) in people with Irritable Bowel Syndrome and Relief of Irritable Bowel Syndrome Symptoms, run by Good Food Practice, Sweden at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Relief of Irritable Bowel Syndrome Symptoms, Quality of Life
- What is being tested?
- Arla Yoghurt with no probiotic and Probiotic yoghurt (Cultura)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2005to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed consent to participate age 18-70 years IBS according to Rome II criteria
- -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: Effects of Cultura Yoghurt on Symptoms Intestinal Flora and Immunological Changes in Patients With Irritable Bowel Syndrome(IBS)
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.
- Being tested
- Arla Yoghurt with no probiotic, Probiotic yoghurt (Cultura)
- Keywords
- IBS (Irritable Bowel Syndrome), Probiotic yoghurt, Symptom severity
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arla Yoghurt with no probioticOther
two servings of 200 ml of investigational products per day
Probiotic yoghurt (Cultura)Other
200 ml per day
| Study group | Role | What they receive |
|---|---|---|
| Probiotic yoghurt (Cultura) | Active comparator | Cultura yoghurt containing: L bulgaricus, S thermophilus Receives: Other: Probiotic yoghurt (Cultura) |
| Yoghurt with no probiotic | Placebo comparator | Not described Receives: Other: Arla Yoghurt with no probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: September 2005 to May 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startSep 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Good Food Practice, Sweden
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Magnus Simrén, Ass Prof, Principal investigator, Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, SwedenMagnus Simren, Ass prof., Principal investigator, Sahlgrenska hospital, Gothenburg, SwedenMagnus Simrén, Ass proff, Principal investigator, Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127828
- Sponsor's protocol ID
- U-05-008
- Status last verified
- May 2010
- First submitted
- 20 May 2010
- Last updated
- 24 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cultura Yoghurt on Symptoms Intestinal Flora and Immunological Changes in Patients With Irritable Bowel Syndrome(IBS)
- ClinicalTrials.gov ID
- NCT01127828
- Acronym / sponsor ID
- U-05-008
- Keywords
- IBS (Irritable Bowel Syndrome), Probiotic yoghurt, Symptom severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Good Food Practice, SwedenIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic yoghurt (Cultura) | Active comparator | Other: Probiotic yoghurt (Cultura)Cultura yoghurt containing: L bulgaricus, S thermophilus |
| Yoghurt with no probiotic | Placebo comparator | Other: Arla Yoghurt with no probiotic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed consent to participate age 18-70 years IBS according to Rome II criteria
- -
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arla Yoghurt with no probiotictwo servings of 200 ml of investigational products per day | Other | Yoghurt with no probiotic |
| Probiotic yoghurt (Cultura)200 ml per day | Other | Probiotic yoghurt (Cultura) |
Primary outcome
Relief of IBS symptoms
Time frame: 6 weeks intervention and 6 weeks follow up
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
1 secondary outcome
Effects on gastrointestinal and extraintestinal symptoms
Time frame: September 2005 to May 2006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arla Yoghurt with no probiotic and Probiotic yoghurt (Cultura) in people with Irritable Bowel Syndrome and Relief of Irritable Bowel Syndrome Symptoms, run by Good Food Practice, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of IBS symptoms (time frame: 6 weeks intervention and 6 weeks follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2010.