Antibiotic-Associated DiarrheaNCT02900196
Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders
A study testing 1 - Fermented dairy drink and 2 - Acidified dairy drink in people with Antibiotic-Associated Diarrhea, run by Danone Global Research & Innovation Center at 1 site in Germany.
Trial summary
The purpose of this clinical study is to evaluate the effect of a four-week consumption of a fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori eradication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antibiotic-Associated Diarrhea
- What is being tested?
- 1 - Fermented dairy drink and 2 - Acidified dairy drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteGermany
- Study dates
- 16 Sep 2016to 10 Aug 2017
- 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
- Subjects who have read and signed the Study Informed Consent Form
- Subjects positive for Helicobacter pylori infection and symptomatic due to Helicobacter pylori infection
- Subjects with an indication, as stated by a Gastroenterologist, for the eradication of Helicobacter pylori
Who cannot join
- Female subjects with a positive pregnancy test (based on serum test), or planning to become pregnant during the study or breast-feeding women
- Subjects enrolled in another interventional clinical study in the last 4 weeks or in an exclusion period following participation in another clinical trial
- Subject who have a history of alcohol abuse
- Subjects having diarrhea within the preceding 4-weeks
- Subjects with severe life-threatening illness, severe evolutive or chronic pathology
- Immune-suppressed subjects
Show all 15Show fewer
- Subjects with benign peptic ulcer or pre-malignant or malignant lesion
- Subjects presenting with an infection of the gastrointestinal tract
- Subjects with any past severe gastro-intestinal or metabolic pathology
- Subjects with history of Helicobacter pylori eradication therapy
- Subjects with history of cardiac or renal clinically significant disease
- Subjects that have had any surgery or intervention requiring general anesthesia in the last 4 weeks, or that have any planned
- Subjects with allergy or hypersensitivity against the medication for the eradication of Helicobacter pylori
- Subjects taking treatments likely to interfere with the evaluation of study parameters.
- Subjects with allergy or hypersensitivity to any component of the study products
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical study is to evaluate the effect of a four-week consumption of a fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori eradication.
- Conditions
- Antibiotic-Associated Diarrhea
- Being tested
- 1 - Fermented dairy drink, 2 - Acidified dairy drink
- Keywords
- Probiotics, Antibiotic Associated Diarrhea, Gastro-Intestinal disorders, Helicobacter pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 - Fermented dairy drinkOther
1 - Fresh fermented dairy drink containing yoghurt ferments and probiotic strains consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)
2 - Acidified dairy drinkOther
2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)
| Study group | Role | What they receive |
|---|---|---|
| 1 - Test | Experimental | Not described Receives: Other: 1 - Fermented dairy drink |
| 2 - Placebo | Placebo comparator | Not described Receives: Other: 2 - Acidified dairy drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of AAD
Measured: From Day 0 to Day 28
Secondary outcomes (7)
Duration of AAD
Measured: From Day 0 to Day 28
Time to event of AAD
Measured: From Day 0 to Day 28
Occurrence of Clostridium difficile Associated Diarrhea
Measured: From Day 0 to Day 28
Time to event of Clostridium difficile Associated Diarrhea
Measured: From Day 0 to Day 28
Duration of Clostridium difficile Associated Diarrhea
Measured: From Day 0 to Day 28
Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting)
Measured: From Day 0 to Day 28
Score of gastrointestinal symptoms
Measured: From Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start16 Sep 2016
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-Associated DiarrheaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Guillemard, PhD, Study chair, Danone Research, Palaiseau, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900196
- Sponsor's protocol ID
- NU372
- Status last verified
- Feb 2018
- First submitted
- 2 Sep 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders
- ClinicalTrials.gov ID
- NCT02900196
- Acronym / sponsor ID
- NU372
- Conditions
- Antibiotic-Associated Diarrhea
- Keywords
- Probiotics, Antibiotic Associated Diarrhea, Gastro-Intestinal disorders, Helicobacter pylori
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2016
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 14 Sep 2016 (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 clinical study is to evaluate the effect of a four-week consumption of a fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori eradication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Test | Experimental | Other: 1 - Fermented dairy drink |
| 2 - Placebo | Placebo comparator | Other: 2 - Acidified dairy drink |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who have read and signed the Study Informed Consent Form
- Subjects positive for Helicobacter pylori infection and symptomatic due to Helicobacter pylori infection
- Subjects with an indication, as stated by a Gastroenterologist, for the eradication of Helicobacter pylori
Key exclusion criteria (15 listed)
- Female subjects with a positive pregnancy test (based on serum test), or planning to become pregnant during the study or breast-feeding women
- Subjects enrolled in another interventional clinical study in the last 4 weeks or in an exclusion period following participation in another clinical trial
- Subject who have a history of alcohol abuse
- Subjects having diarrhea within the preceding 4-weeks
- Subjects with severe life-threatening illness, severe evolutive or chronic pathology
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 dairy drink1 - Fresh fermented dairy drink containing yoghurt ferments and probiotic strains consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28) | Other | 1 - Test |
| 2 - Acidified dairy drink2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28) | Other | 2 - Placebo |
Primary outcome
Occurrence of AAD
Time frame: From Day 0 to Day 28
7 secondary outcomes
Duration of AAD
Time frame: From Day 0 to Day 28
Time to event of AAD
Time frame: From Day 0 to Day 28
Occurrence of Clostridium difficile Associated Diarrhea
Time frame: From Day 0 to Day 28
Time to event of Clostridium difficile Associated Diarrhea
Time frame: From Day 0 to Day 28
Duration of Clostridium difficile Associated Diarrhea
Time frame: From Day 0 to Day 28
Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting)
Time frame: From Day 0 to Day 28
Score of gastrointestinal symptoms
Time frame: From Day 0 to Day 28
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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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.
Eric Guillemard, PhD study chair
Danone Research, Palaiseau, France
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 dairy drink and 2 - Acidified dairy drink in people with Antibiotic-Associated Diarrhea, run by Danone Global Research & Innovation Center at 1 site in Germany.
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 15 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: stopped early, as of the sponsor's last update on 7 Feb 2018. 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 Germany. 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Occurrence of AAD (time frame: From Day 0 to Day 28). 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 7 Feb 2018.