Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Antibiotic-associated Diarrhea

Intervention / Treatment
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* Other: probiotic dairy drink
* Other: acidified milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>2 bottles (á 65ml) of a probiotic dairy drink consumed daily for 6 weeks | Other: probiotic dairy drink<br> <br> * Other names: verum;|
| Placebo Comparator: Placebo<br>2 bottles (á 65ml) of a dairy drink containing chemically acidified milk without bacterial strains consumed daily for 6 weeks | Other: acidified milk<br> <br> * Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Antibiotics, AAD, Helicobacter p.