Antibiotic-associated DiarrheaNCT02746198
Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD)
A study testing probiotic dairy drink and acidified milk in people with Antibiotic-associated Diarrhea, run by Clinical Research Center Kiel GmbH at 1 site in Germany.
Trial summary
The aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- probiotic dairy drink and acidified milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jan 2016to 26 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals, both genders, aged ≥ 18 y
- Helicobacter p. infected individuals, to which eradication therapy has been recommended by gastroenterologists
- Willingness to undergo the Helicobacter p. eradication therapy
- Willingness to abstain from food and supplements containing probiotics, prebiotics and fermented products except the study product
- Written informed consent
Who cannot join
- Subjects currently enrolled in another interventional trial
- subjects having finished another interventional trial within the last 4 weeks before inclusion
- incapacity to comply with the study protocol
- allergy or hypersensitivity to any component of the test product (allergy against milk protein)
- allergy or hypersensitivity to any component of the eradication therapy (e.g. penicillin allergy)
- acute GIT infections
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- chronic inflammatory bowel diseases (IBD)
- irritable bowel syndrome (IBS)
- any episode of diarrhea according to WHO criteria during the last 4 weeks before inclusion
- history of lactose intolerance
- severe chronic disease (cancer, malabsorption, malnutrition, severe chronic inflammatory diseases (except chronic gastritis), renal, hepatic or cardiac diseases, artificial cardiac valve, COPD, respiratory insufficiency)
- history of active or persistent hepatitis B and C
- known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
- systemic treatment with antibiotics during the last 4 weeks before inclusion
- systemic treatment likely influencing absorption, metabolism and excretion of food ingredients (metoclopramide, laxatives, body weight management and/or medication etc.)
- systemic treatment likely interfering or influencing effectiveness of the eradication drugs used e.g. ergotamine, statins, clopidogrel
- regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
- severe neurological, cognitive or psychiatric diseases
- surgery or intervention requiring general anaesthesia within 2 months before the study
- vegan
- eating disorders (e.g. anorexia, bulimia)
- present alcohol and drug abuse
- pregnancy or lactation
- legal incapacity
- blood parameters:
- Hb < 12 g/dL
- liver transaminases (ALT, AST) > 2-fold increased
- serum creatinine out of the normal range
- subjects who are scheduled to undergo hospitalization during the study period
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRC Clinical Research Center Kiel
Kiel, Schleswig-Holstein, 24118
About this study
Official title: A Randomized Double-blind Placebo-controlled Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD) in Patients With Helicobacter Pylori Eradication Therapy
The aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory study.
Read the detailed description
Helicobacter p. positive subjects aged ≥18 years with an indication for Helicobacter pylori (Hp) eradication recommended by a gastroenterologist should be included in the study. Subjects should be willing to consume 2 servings of the study product per day for 6 weeks, and to undergo an Hp eradication therapy for 14 days starting with the consumption period.
- Conditions
- Antibiotic-associated Diarrhea
- Being tested
- probiotic dairy drink, acidified milk
- Keywords
- Probiotics, Antibiotics, AAD, Helicobacter p.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic dairy drinkOther
Also called verum
acidified milkOther
Also called placebo
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | 2 bottles (á 65ml) of a probiotic dairy drink consumed daily for 6 weeks Receives: Other: probiotic dairy drink |
| Placebo | Placebo comparator | 2 bottles (á 65ml) of a dairy drink containing chemically acidified milk without bacterial strains consumed daily for 6 weeks Receives: Other: acidified milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of antibiotic-associated diarrhea (AAD)
Occurrence of antibiotic-associated diarrhea (AAD) (as defined by number of subjects with diarrhea within the intervention period of 6 weeks after starting antibiotic treatment; diarrhea is defined according WHO
Measured: 6 weeks
Secondary outcomes (3)
Cumulated duration of antibiotic-associated diarrhea (AAD)
Number of days with diarrhea within the intervention period
Measured: 6 weeks
Gastrointestinal Symptom Rating Scale
Standardized questionnaire according Dimenäs et al.
Measured: 6 weeks
Cumulative sverity of antibiotic-associated diarrhea (AAD)
Sum of the values (obtained by transformation of Bristol stool form types) of all stools during days with diarrhea (transformation of Bristol scale types is defined: type 1 to 4 = 0; type 5 = 1; type 6 = 2 and type 7 = 3)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start22 Jan 2016
- Primary completion23 Dec 2016
- Study completion26 Apr 2017
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center Kiel GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Responsible party
- Sponsor
- Investigators
- Chiyuki Kajita, Study chair, Yakult Europe BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746198
- Sponsor's protocol ID
- 14DE-KIEL-HPAAD1
- Status last verified
- Feb 2021
- First submitted
- 12 Apr 2016
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo-controlled Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD) in Patients With Helicobacter Pylori Eradication Therapy
- ClinicalTrials.gov ID
- NCT02746198
- Acronym / sponsor ID
- 14DE-KIEL-HPAAD1
- Conditions
- Antibiotic-associated Diarrhea
- Keywords
- Probiotics, Antibiotics, AAD, Helicobacter p.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Clinical Research Center Kiel GmbHUniversity, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 21 Apr 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 aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory study.
Detailed description
Helicobacter p. positive subjects aged ≥18 years with an indication for Helicobacter pylori (Hp) eradication recommended by a gastroenterologist should be included in the study. Subjects should be willing to consume 2 servings of the study product per day for 6 weeks, and to undergo an Hp eradication therapy for 14 days starting with the consumption period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Other: probiotic dairy drink2 bottles (á 65ml) of a probiotic dairy drink consumed daily for 6 weeks |
| Placebo | Placebo comparator | Other: acidified milk2 bottles (á 65ml) of a dairy drink containing chemically acidified milk without bacterial strains consumed daily for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals, both genders, aged ≥ 18 y
- Helicobacter p. infected individuals, to which eradication therapy has been recommended by gastroenterologists
- Willingness to undergo the Helicobacter p. eradication therapy
- Willingness to abstain from food and supplements containing probiotics, prebiotics and fermented products except the study product
- Written informed consent
Key exclusion criteria (29 listed)
- Subjects currently enrolled in another interventional trial
- subjects having finished another interventional trial within the last 4 weeks before inclusion
- incapacity to comply with the study protocol
- allergy or hypersensitivity to any component of the test product (allergy against milk protein)
- allergy or hypersensitivity to any component of the eradication therapy (e.g. penicillin allergy)
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 |
|---|---|---|
| probiotic dairy drinkAlso: verum | Other | Verum |
| acidified milkAlso: placebo | Other | Placebo |
Primary outcome
Occurrence of antibiotic-associated diarrhea (AAD)
Time frame: 6 weeks
Occurrence of antibiotic-associated diarrhea (AAD) (as defined by number of subjects with diarrhea within the intervention period of 6 weeks after starting antibiotic treatment; diarrhea is defined according WHO
3 secondary outcomes
Cumulated duration of antibiotic-associated diarrhea (AAD)
Time frame: 6 weeks
Gastrointestinal Symptom Rating Scale
Time frame: 6 weeks
Cumulative sverity of antibiotic-associated diarrhea (AAD)
Time frame: 6 weeks
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 8 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Chiyuki Kajita study chair
Yakult Europe BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic dairy drink and acidified milk in people with Antibiotic-associated Diarrhea, run by Clinical Research Center Kiel GmbH 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 5 inclusion and 29 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 8 Feb 2021. 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 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?
Occurrence of antibiotic-associated diarrhea (AAD) (time frame: 6 weeks). 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 8 Feb 2021.