Healthy Adult WomenNCT01388010
Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women
A study testing 1-Fermented Probiotic Dairy Product (test) in people with Healthy Adult Women, run by Danone Global Research & Innovation Center at 1 site in France.
Trial summary
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Women
- What is being tested?
- 1-Fermented Probiotic Dairy Product (test)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Oct 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female free-living subject aged from 18 to 60 years.
- Subject with a body mass index between 18 and 30.
- Subject with minor digestive symptoms as defined by screening questionnaire of frequency of digestive symptoms.
- Subject with normal stool frequency
Who cannot join
- Subject with a diagnosis of Irritable Bowel Syndrome (IBS) or other functional bowel disease (constipation, diarrhoea…)
- Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
- Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs
- Subject having taken antibiotics in the last 4 weeks
- Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
- Subject with known lactose intolerance or immunodeficiency
- Subject with known allergy to product component (milk protein for example)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.
- Conditions
- Healthy Adult Women
- Being tested
- 1-Fermented Probiotic Dairy Product (test), 2-Milk-based non-fermented dairy product(control)
- Keywords
- probiotics, gastrointestinal well being, digestive symptoms, healthy population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Fermented Probiotic Dairy Product (test)Other
2-Milk-based non-fermented dairy product(control)Other
| Study group | Role | What they receive |
|---|---|---|
| 1 = Test product | Experimental | Arm 1 - Intervention 1 (probiotics) Receives: Other: 1-Fermented Probiotic Dairy Product (test) |
| 2 = Control product | Other | Arm 2 - Intervention 2 (control) Receives: Other: 2-Milk-based non-fermented dairy product(control) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult WomenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 336 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
- NCT01388010
- Sponsor's protocol ID
- NU325
- Status last verified
- Oct 2016
- First submitted
- 3 Jul 2011
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"
- ClinicalTrials.gov ID
- NCT01388010
- Acronym / sponsor ID
- NU325
- Conditions
- Healthy Adult Women
- Keywords
- probiotics, gastrointestinal well being, digestive symptoms, healthy population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Jul 2011 (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 purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 = Test product | Experimental | Other: 1-Fermented Probiotic Dairy Product (test)Arm 1 - Intervention 1 (probiotics) |
| 2 = Control product | Other | Other: 2-Milk-based non-fermented dairy product(control)Arm 2 - Intervention 2 (control) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female free-living subject aged from 18 to 60 years.
- Subject with a body mass index between 18 and 30.
- Subject with minor digestive symptoms as defined by screening questionnaire of frequency of digestive symptoms.
- Subject with normal stool frequency
Key exclusion criteria (7 listed)
- Subject with a diagnosis of Irritable Bowel Syndrome (IBS) or other functional bowel disease (constipation, diarrhoea…)
- Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
- Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs
- Subject having taken antibiotics in the last 4 weeks
- Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
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 |
|---|---|---|
| 1-Fermented Probiotic Dairy Product (test) | Other | 1 = Test product |
| 2-Milk-based non-fermented dairy product(control) | Other | 2 = Control product |
Primary outcome
Not reported in the source record.
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 27 Oct 2016.
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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 1-Fermented Probiotic Dairy Product (test) in people with Healthy Adult Women, run by Danone Global Research & Innovation Center at 1 site in France.
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 4 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 27 Oct 2016. 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 France. 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. 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.
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 27 Oct 2016.