HealthyNCT02461485
Effect of a Fermented Milk Product With Probiotics Alone or in Combination With Fibers on Constipation Symptoms
A study testing Fermented milk product containing Probiotics, Fermented Milk Product containing Probiotics + Fibers C and Fermented Milk Product containing Probiotics + Fibers W in people with Healthy and Constipation, run by Danone Global Research & Innovation Center at 1 site in Ireland.
Trial summary
First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Constipation
- What is being tested?
- Fermented milk product containing Probiotics, Fermented Milk Product containing Probiotics + Fibers C and Fermented Milk Product containing Probiotics + Fibers W
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteIreland
- Study dates
- May 2015to 12 Oct 2016
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main eligibility criteria (non-exhaustive list) are defined as:
- Healthy Caucasian subject of both gender, aged from 18 to 69 years
- Subject with body mass index (BMI) between 18 kg/m2 (bound included) and 30 kg/m2 (bound excluded)
- Subjects with moderate constipation defined according to ROME III adapted criteria.
- Subjects without ongoing or diagnosed gastrointestinal disease or complications.
- Subjects without previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function.
- Subjects without known gluten intolerance, lactose intolerance or allergy to milk proteins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effects of Fermented Dairy Products Containing Probiotics Alone or in Association With Fibers on Bowel Functions, Constipation Symptoms and Health Related Quality of Life in Adult Subjects With Moderate Constipation: an Exploratory Randomized Double-blind, Controlled Adaptive Study
First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.
- Conditions
- Healthy, Constipation
- Being tested
- Fermented milk product containing Probiotics, Fermented Milk Product containing Probiotics + Fibers C, Fermented Milk Product containing Probiotics + Fibers W, Non fermented Milk Product
- Keywords
- adults, moderate constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented milk product containing ProbioticsOther
2 pots/day during 28 days
Fermented Milk Product containing Probiotics + Fibers COther
2 pots/day during 28 days
Fermented Milk Product containing Probiotics + Fibers WOther
2 pots/day during 28 days
Non fermented Milk ProductOther
2 pots/day during 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1=BOW_01 | Experimental | 1= Fermented Milk Product containing Probiotics Receives: Other: Fermented milk product containing Probiotics |
| 2=BOW_01 + fiber C | Experimental | 2= Fermented Milk Product containing Probiotics + Fibers C Receives: Other: Fermented Milk Product containing Probiotics + Fibers C |
| 3 =BOW_01 + fiber W | Experimental | 3= Fermented Milk Product containing Probiotics + Fibers W Receives: Other: Fermented Milk Product containing Probiotics + Fibers W |
| 4 = Control | Placebo comparator | 4= Non fermented Milk Product with same color, texture and organoleptic properties as investigational products 1 to 3. Receives: Other: Non fermented Milk Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.
Measured: Baseline and after 4 weeks.
Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.
Measured: Baseline and after 4 weeks.
Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.
Measured: Baseline and during the 4th week.
Change in fecal bulk (stool weight) at baseline and after 4 weeks.
Measured: Baseline and after 4 weeks.
Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.
Measured: Baseline and after 2 and 4 weeks. Validated questionnaire.
Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks.
Measured: Baseline and after 2 and 4 weeks. Validated questionnaire.
Study product satisfaction by questionnaire after 2 and 4 weeks.
Measured: after 2 and 4 weeks.
Adverse events in the week before baseline, at baseline, week 3, 4 and 5.
Measured: Evaluation of safety will be assessed with AE and SAE reporting throughout the whole study i.e. day -7 (screening period), day 0 (randomisation), day 15, day 22 and day 29 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016
- Study completion12 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461485
- Sponsor's protocol ID
- NU373
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effects of Fermented Dairy Products Containing Probiotics Alone or in Association With Fibers on Bowel Functions, Constipation Symptoms and Health Related Quality of Life in Adult Subjects With Moderate Constipation: an Exploratory Randomized Double-blind, Controlled Adaptive Study
- ClinicalTrials.gov ID
- NCT02461485
- Acronym / sponsor ID
- NU373
- Conditions
- Healthy, Constipation
- Keywords
- adults, moderate constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- 12 Oct 2016 (actual)
- First posted
- 3 Jun 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.
First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1=BOW_01 | Experimental | Other: Fermented milk product containing Probiotics1= Fermented Milk Product containing Probiotics |
| 2=BOW_01 + fiber C | Experimental | Other: Fermented Milk Product containing Probiotics + Fibers C2= Fermented Milk Product containing Probiotics + Fibers C |
| 3 =BOW_01 + fiber W | Experimental | Other: Fermented Milk Product containing Probiotics + Fibers W3= Fermented Milk Product containing Probiotics + Fibers W |
| 4 = Control | Placebo comparator | Other: Non fermented Milk Product4= Non fermented Milk Product with same color, texture and organoleptic properties as investigational products 1 to 3. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Fermented milk product containing Probiotics2 pots/day during 28 days | Other | 1=BOW_01 |
| Fermented Milk Product containing Probiotics + Fibers C2 pots/day during 28 days | Other | 2=BOW_01 + fiber C |
| Fermented Milk Product containing Probiotics + Fibers W2 pots/day during 28 days | Other | 3 =BOW_01 + fiber W |
| Non fermented Milk Product2 pots/day during 28 days | Other | 4 = Control |
Primary outcome
Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.
Time frame: Baseline and after 4 weeks.
Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.
Time frame: Baseline and after 4 weeks.
Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.
Time frame: Baseline and during the 4th week.
Change in fecal bulk (stool weight) at baseline and after 4 weeks.
Time frame: Baseline and after 4 weeks.
Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.
Time frame: Baseline and after 2 and 4 weeks. Validated questionnaire.
Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks.
Time frame: Baseline and after 2 and 4 weeks. Validated questionnaire.
Study product satisfaction by questionnaire after 2 and 4 weeks.
Time frame: after 2 and 4 weeks.
Adverse events in the week before baseline, at baseline, week 3, 4 and 5.
Time frame: Evaluation of safety will be assessed with AE and SAE reporting throughout the whole study i.e. day -7 (screening period), day 0 (randomisation), day 15, day 22 and day 29 (end of study)
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 22 Aug 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented milk product containing Probiotics, Fermented Milk Product containing Probiotics + Fibers C and Fermented Milk Product containing Probiotics + Fibers W in people with Healthy and Constipation, run by Danone Global Research & Innovation Center at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Aug 2017. 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 Ireland. 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 frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks. (time frame: Baseline and after 4 weeks.). The study lists 8 primary outcomes in all. 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 22 Aug 2017.