clinical pilot trial on the effect of a probiotic fermented drink on antibiotic-associated diarrhea (aad)

Conditions: Antibiotic-associated Diarrhea

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.

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.

Eligibility criteria:
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

Keywords: probiotics, antibiotics, aad, helicobacter p.