Irritable Bowel SyndromeNCT02391220
Assessment of the Symbiotic Fermented Milk in Patients With Irritable Bowel Syndrome
A study testing LCA symbiotic fermented milk and heat-treated fermented milk in people with Irritable Bowel Syndrome, run by Clinres Farmacija d.o.o..
Trial summary
This study evaluates the effect of a symbiotic fermented milk on health-related quality of life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant IBS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- LCA symbiotic fermented milk and heat-treated fermented milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jan 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed constipation-predominant irritable bowel syndrome (on the basis of Rome III criteria) (≥ 25 % lumpy or hard stools and ≤ 25 % mushy or watery stools).
- Meeting Rome III criteria for the determination of irritable bowel syndrome in the last 6 months prior to inclusion and the presence of symptoms such as abdominal pain, bloating and general digestive discomfort at least twice a week in the last 3 months prior to inclusion.
- Colonoscopy in the last 7 years prior to inclusion with normal results.
Who cannot join
- Diarrhoea-predominant irritable bowel syndrome (≥ 25 % mushy or watery stools and ≤ 25 % lumpy or hard stools).
- Clinical signs of alarm, such as rectorrhagia, fever, recent unexplained weight loss.
- Organic gastrointestinal diseases, including chronic inflammatory bowel disease and systemic diseases with gastrointestinal difficulties.
- Severe abdominal pain and the taking of analgesics or antispasmodics for the previous 5 days or more.
- Having begun treatment with psychotropic medicines or other drugs for the treatment of irritable bowel syndrome within the previous month.
- Dietary habits that could influence the assessment of the investigational product, such as slimming or a vegetarian diet.
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- Known allergy to ingredient(s) in the investigational product.
- Known medical or psycho-physical condition that is, in the opinion of the investigator, in conflict with consumption of the investigational product and/or the course of the study.
- Participation in another clinical study less than one month before inclusion or concurrent participation in another clinical study.
About this study
Official title: The Effect of a Symbiotic LCA Yoghurt on Health-related Quality of Life and the Symptoms of Irritable Bowel Syndrome in Adults: A Randomized, Double-blind, Placebo Controlled, Multicentre Clinical Trial
This study evaluates the effect of a symbiotic fermented milk on health-related quality of life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant IBS.
Read the detailed description
Irritable bowel syndrome (IBS) is one of the most common digestive disorders in the developed world which. It is associated to numerous symptoms, of which the most characteristic are recurrent pain or discomfort in the abdominal region, changes and difficulties related to bowel movements, and bloating. Although not dangerous, the disease may significantly impair the patients' quality of life. Treatment is symptomatic, but currently not very efficient. The use of probiotics in the treatment of IBS is a promising approach and has been the subject of much research in the last two decades.
The purpose of this randomized, placebo-controlled study is to assess changes in health-related quality of life in patients with constipation-predominant IBS after regular consumption of symbiotic fermented milk (containing probiotics and dietary fibres) and to assess its effects on some symptoms, like abdominal pain or discomfort, bloating, and chronic constipation.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- LCA symbiotic fermented milk, heat-treated fermented milk
- 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.
LCA symbiotic fermented milkOther
LCA symbiotic fermented milk with the probiotic cultures Lactobacillus acidophilus La-5® and Bifidobacterium animalis ssp. lactis BB-12® and the Beneo dietary fibers.
heat-treated fermented milkOther
heat-treated fermented milk without probiotic cultures and dietary fibres
| Study group | Role | What they receive |
|---|---|---|
| Symbiotic | Active comparator | LCA symbiotic fermented milk, 180 g pot, twice daily. Receives: Other: LCA symbiotic fermented milk |
| Placebo | Placebo comparator | heat-treated fermented milk, 180 g pot, twice daily. Receives: Other: heat-treated fermented milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
assessed by IBS-QoL questionnaire
Measured: 4 weeks of product consumption
Secondary outcomes (3)
Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)
assessed by IBS - Severity Scoring System
Measured: 4 weeks of product consumption
Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)
assessed by IBS - Severity Scoring System
Measured: 2 weeks of product consumption
Quality of life
assessed by IBS-QoL questionnaire
Measured: 2 weeks of product consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionJan 2013
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinres Farmacija d.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Competence Centre for Biotechnology Research and Innovation, European Regional Development Fund, Ministry of Higher Education, Science and Technology, Solvenia, Institute of Dairy Science and probiotics, Biotechnical Faculty, UL, Dairy Celeia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391220
- Sponsor's protocol ID
- KC_BRIN
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Symbiotic LCA Yoghurt on Health-related Quality of Life and the Symptoms of Irritable Bowel Syndrome in Adults: A Randomized, Double-blind, Placebo Controlled, Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT02391220
- Acronym / sponsor ID
- KC_BRIN
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Clinres Farmacija d.o.o.Industry (pharma, biotech, devices)
- Collaborators
- Competence Centre for Biotechnology Research and Innovation, European Regional Development Fund, Ministry of Higher Education, Science and Technology, Solvenia, Institute of Dairy Science and probiotics, Biotechnical Faculty, UL, Dairy Celeia
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Mar 2015 (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.
This study evaluates the effect of a symbiotic fermented milk on health-related quality of life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant IBS.
Detailed description
Irritable bowel syndrome (IBS) is one of the most common digestive disorders in the developed world which. It is associated to numerous symptoms, of which the most characteristic are recurrent pain or discomfort in the abdominal region, changes and difficulties related to bowel movements, and bloating. Although not dangerous, the disease may significantly impair the patients' quality of life. Treatment is symptomatic, but currently not very efficient. The use of probiotics in the treatment of IBS is a promising approach and has been the subject of much research in the last two decades.
The purpose of this randomized, placebo-controlled study is to assess changes in health-related quality of life in patients with constipation-predominant IBS after regular consumption of symbiotic fermented milk (containing probiotics and dietary fibres) and to assess its effects on some symptoms, like abdominal pain or discomfort, bloating, and chronic constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbiotic | Active comparator | Other: LCA symbiotic fermented milkLCA symbiotic fermented milk, 180 g pot, twice daily. |
| Placebo | Placebo comparator | Other: heat-treated fermented milkheat-treated fermented milk, 180 g pot, twice daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed constipation-predominant irritable bowel syndrome (on the basis of Rome III criteria) (≥ 25 % lumpy or hard stools and ≤ 25 % mushy or watery stools).
- Meeting Rome III criteria for the determination of irritable bowel syndrome in the last 6 months prior to inclusion and the presence of symptoms such as abdominal pain, bloating and general digestive discomfort at least twice a week in the last 3 months prior to inclusion.
- Colonoscopy in the last 7 years prior to inclusion with normal results.
Key exclusion criteria (9 listed)
- Diarrhoea-predominant irritable bowel syndrome (≥ 25 % mushy or watery stools and ≤ 25 % lumpy or hard stools).
- Clinical signs of alarm, such as rectorrhagia, fever, recent unexplained weight loss.
- Organic gastrointestinal diseases, including chronic inflammatory bowel disease and systemic diseases with gastrointestinal difficulties.
- Severe abdominal pain and the taking of analgesics or antispasmodics for the previous 5 days or more.
- Having begun treatment with psychotropic medicines or other drugs for the treatment of irritable bowel syndrome within the previous month.
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 |
|---|---|---|
| LCA symbiotic fermented milkLCA symbiotic fermented milk with the probiotic cultures Lactobacillus acidophilus La-5® and Bifidobacterium animalis ssp. lactis BB-12® and the Beneo dietary fibers. | Other | Symbiotic |
| heat-treated fermented milkheat-treated fermented milk without probiotic cultures and dietary fibres | Other | Placebo |
Primary outcome
Quality of life
Time frame: 4 weeks of product consumption
assessed by IBS-QoL questionnaire
3 secondary outcomes
Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)
Time frame: 4 weeks of product consumption
Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)
Time frame: 2 weeks of product consumption
Quality of life
Time frame: 2 weeks of product consumption
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 28 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LCA symbiotic fermented milk and heat-treated fermented milk in people with Irritable Bowel Syndrome, run by Clinres Farmacija d.o.o..
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 3 inclusion and 9 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 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Quality of life (time frame: 4 weeks of product consumption). 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 28 Jul 2015.