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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
125
CRC Clinical Research Center Kiel
Kiel, Schleswig-Holstein, Germany
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
Time frame: 6 weeks
Cumulated duration of antibiotic-associated diarrhea (AAD)
Number of days with diarrhea within the intervention period
Time frame: 6 weeks
Gastrointestinal Symptom Rating Scale
Standardized questionnaire according Dimenäs et al.
Time frame: 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)
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.