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

Clinical Research Center Kiel

Status

Completed

Conditions

Antibiotic-associated Diarrhea

Treatments

Other: acidified milk

Other: probiotic dairy drink

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02746198

14DE-KIEL-HPAAD1

Details and patient eligibility

About

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.

Full 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.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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