Clinical trial NCT02746198: Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic-associated Diarrhea
Keywords: Probiotics, Antibiotics, AAD, Helicobacter p.
Lead sponsor: Clinical Research Center Kiel GmbH
Sponsor class: OTHER
Collaborators: name: Yakult Honsha Co., LTD
First posted: 2016-04-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

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

Primary outcomes:
measure: Occurrence of antibiotic-associated diarrhea (AAD)
timeFrame: 6 weeks
Secondary outcomes:
measure: Cumulated duration of antibiotic-associated diarrhea (AAD)
timeFrame: 6 weeks
measure: Gastrointestinal Symptom Rating Scale
timeFrame: 6 weeks
measure: Cumulative sverity of antibiotic-associated diarrhea (AAD)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRC Clinical Research Center Kiel
state: Schleswig-Holstein
Study officials:
affiliation: Yakult Europe BV
name: Chiyuki Kajita
role: STUDY_CHAIR
References: