ConstipationNCT01102036
Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort in Healthy Women and Men
A study testing Cultura L casei F19, acidophilus La5 , B lactis Bb 12 and Yoghurt without probiotics in people with Constipation, run by Good Food Practice, Sweden at 1 site in Sweden.
Trial summary
The aim of this study is to determine the effect of cultura yoghurt on transit time and digestive discomfort during 2 weeks of treatment in comparison to placebo in healthy women and men. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Cultura L casei F19, acidophilus La5 , B lactis Bb 12 and Yoghurt without probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2010to Jun 2010
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female and Males
- Healthy
- BMI 19-29 at visit 1
- Age 18 and 60 years at visit 1
- Defecation 3-4 times per week or every second to third day (Bristol Stool Form) during the run-in
- Transit time 35 and 72 hours calculated from the abdominal X-ray at visit 3
- Signed written informed consent
Who cannot join
- Use of probiotics food or supplements during the study
- Past history of digestive disease
- Previous complicated GI surgery
- Oral use of antimicrobial medication or antimicrobial prophylaxis 4 weeks prior to screening visit
- Use of laxatives (medication or dietary supplements) during the study.
- Pregnant or lactating or wish to become pregnant during the period of the study
- Lack of suitability for participation in the trial, for any reason, as judged by the personnel at KPL Good Food Practice AB
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort During 2 Weeks of Treatment in Comparison to Placebo in Healthy Women and Men
The aim of this study is to determine the effect of cultura yoghurt on transit time and digestive discomfort during 2 weeks of treatment in comparison to placebo in healthy women and men.
Read the detailed description
Transit time is the time it takes for a substance to pass through the gut. The major part of the transit is spent in the large bowel is therefore mainly a colonic event. It has been observed that slow transit time is associated with high prevalence of large bowel disorders. The objectives of this study is to:
- determine the effect on mean transit time after 2 weeks intake of a investigational products using radio-opaque sulphate impregnated polyethylene pellets as markers.
- determine effect of investigational products on total symptom score according to Bristol Stool Form (BSF)
- determine effect of investigational products in gastrointestinal symptoms
- determine safety of intake of the investigational products
- Conditions
- Constipation
- Being tested
- Cultura L casei F19, acidophilus La5 , B lactis Bb 12, Yoghurt without probiotics
- Keywords
- Transit time, constipation, gut regularity, defecation frequency, Colonic transit time
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultura L casei F19, acidophilus La5 , B lactis Bb 12Other
Also called Cultura probiotic yoghurt, Yoghurt without prbiotics
2 weeks consumption,250 ml/day
Yoghurt without probioticsOther
Yoghurt without probiotics
| Study group | Role | What they receive |
|---|---|---|
| Yoghurt without probiotics | Placebo comparator | Yoghurt without probiotic bacteria Receives: Other: Yoghurt without probiotics |
| Cultura yoghurt | Active comparator | Cultura yoghurt with L casei F19, acidophilus La5 adn B lactis Bb 12 Receives: Other: Cultura L casei F19, acidophilus La5 , B lactis Bb 12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transit time between treatments
To determine the effect on mean transit time after 2 weeks intake of investigational products using radio-opaque barium sulphate impregnated polyethylen capsules. These capsules will be consumed during 3 days and thereafter an x-ray image will be taken over the bowel. The capsulese will then be calculated to determine the colonic transit time
Measured: February 2010-June 2010
Secondary outcomes (2)
Change between treatments on Bristol Stool Form (BSF)symptoms scores
To determine the effect of Cultura yoghurt on the total symptom score according to Bristol Stool Form (BSF) scale during 2 weeks of treatment in comparison to placebo in healthy women and men
Measured: February 2010-June2010
Change between treatments on gastrointestinal symptoms according to Bristol Stool Form
To determine the effect of Cultura yoghurt on gastrointestinal symptoms according to the Bristol Stool Form (BSF) after 2 weeks treatment of investigational products
Measured: February 2010-June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Good Food Practice, Sweden
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arla Foods
- Responsible party
- Principal investigator, Birgitta Sundberg, Good Food Practice, Sweden
- Investigators
- Lars Magnusson, CEO, Study director, Good Food Practice, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102036
- Sponsor's protocol ID
- C-X-Ray U-09-017
- Status last verified
- Apr 2010
- First submitted
- 8 Apr 2010
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort During 2 Weeks of Treatment in Comparison to Placebo in Healthy Women and Men
- ClinicalTrials.gov ID
- NCT01102036
- Acronym / sponsor ID
- C-X-Ray U-09-017
- Conditions
- Constipation
- Keywords
- Transit time, constipation, gut regularity, defecation frequency, Colonic transit time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Good Food Practice, SwedenIndustry (pharma, biotech, devices)
- Collaborators
- Arla Foods
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Apr 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.
The aim of this study is to determine the effect of cultura yoghurt on transit time and digestive discomfort during 2 weeks of treatment in comparison to placebo in healthy women and men.
Detailed description
Transit time is the time it takes for a substance to pass through the gut. The major part of the transit is spent in the large bowel is therefore mainly a colonic event. It has been observed that slow transit time is associated with high prevalence of large bowel disorders. The objectives of this study is to:
- determine the effect on mean transit time after 2 weeks intake of a investigational products using radio-opaque sulphate impregnated polyethylene pellets as markers.
- determine effect of investigational products on total symptom score according to Bristol Stool Form (BSF)
- determine effect of investigational products in gastrointestinal symptoms
- determine safety of intake of the investigational products
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoghurt without probiotics | Placebo comparator | Other: Yoghurt without probioticsYoghurt without probiotic bacteria |
| Cultura yoghurt | Active comparator | Other: Cultura L casei F19, acidophilus La5 , B lactis Bb 12Cultura yoghurt with L casei F19, acidophilus La5 adn B lactis Bb 12 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female and Males
- Healthy
- BMI 19-29 at visit 1
- Age 18 and 60 years at visit 1
- Defecation 3-4 times per week or every second to third day (Bristol Stool Form) during the run-in
Key exclusion criteria (7 listed)
- Use of probiotics food or supplements during the study
- Past history of digestive disease
- Previous complicated GI surgery
- Oral use of antimicrobial medication or antimicrobial prophylaxis 4 weeks prior to screening visit
- Use of laxatives (medication or dietary supplements) during the study.
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 |
|---|---|---|
| Cultura L casei F19, acidophilus La5 , B lactis Bb 12Also: Cultura probiotic yoghurt, Yoghurt without prbiotics2 weeks consumption,250 ml/day | Other | Cultura yoghurt |
| Yoghurt without probioticsYoghurt without probiotics | Other | Yoghurt without probiotics |
Primary outcome
Change in transit time between treatments
Time frame: February 2010-June 2010
To determine the effect on mean transit time after 2 weeks intake of investigational products using radio-opaque barium sulphate impregnated polyethylen capsules. These capsules will be consumed during 3 days and thereafter an x-ray image will be taken over the bowel. The capsulese will then be calculated to determine the colonic transit time
2 secondary outcomes
Change between treatments on Bristol Stool Form (BSF)symptoms scores
Time frame: February 2010-June2010
Change between treatments on gastrointestinal symptoms according to Bristol Stool Form
Time frame: February 2010-June 2010
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 26 Aug 2011.
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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.
Lars Magnusson, CEO study director
Good Food Practice, Uppsala, 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 Cultura L casei F19, acidophilus La5 , B lactis Bb 12 and Yoghurt without probiotics in people with Constipation, 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 7 inclusion and 7 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 26 Aug 2011. 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?
Change in transit time between treatments (time frame: February 2010-June 2010). 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 26 Aug 2011.