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| Name | Class |
|---|---|
| Yakult Honsha Co., LTD | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | 2 bottles (á 65ml) of a probiotic dairy drink consumed daily for 6 weeks |
|
| Placebo | Placebo Comparator | 2 bottles (á 65ml) of a dairy drink containing chemically acidified milk without bacterial strains consumed daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic dairy drink | Other |
|
| |
| acidified milk |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulated duration of antibiotic-associated diarrhea (AAD) | Number of days with diarrhea within the intervention period | 6 weeks |
| Gastrointestinal Symptom Rating Scale | Standardized questionnaire according Dimenäs et al. |
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Inclusion Criteria:
Exclusion Criteria:
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
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:
subjects who are scheduled to undergo hospitalization during the study period
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| Name | Affiliation | Role |
|---|---|---|
| Chiyuki Kajita | Yakult Europe BV | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRC Clinical Research Center Kiel | Kiel | Schleswig-Holstein | 24118 | Germany |
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| ID | Term |
|---|---|
| C068637 | calcium D-pantothenate, L-cysteine drug combination |
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| Other |
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| 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) | 6 weeks |