The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms (PANDA)
Antibiotic-associated Diarrhea
About this trial
This is an interventional treatment trial for Antibiotic-associated Diarrhea focused on measuring Probiotic, Antibiotic-associated Diarrhea, GI microbiome, Lactobacillus, Bifidobacterium
Eligibility Criteria
Inclusion Criteria: Males and females ≥ 18 years and ≤65 years old Body Mass Index 18.5-30 kg/m2 Generally in good health Use of broad spectrum orally administered AB(s) for no more than 24h prior to V1 (penicillins, cephalosporins, quinolones, tetracyclines and lincomycins) for diagnosed infections other than those of GI, urinary or reproductive tract not requiring hospitalization, with a foreseen total duration of AB intake of 5-7 days Having access to a smartphone/tablet or a computer with an internet access, and familiar with the use thereof (checked during the visit) Readiness to keep dietary habits during the study Readiness to avoid the use of any nutritional (e. g. prebiotic, probiotic), medical and further interventional options for management of GI complaints/diarrhoea (beyond the IP) during the study Women of childbearing potential: commitment to use contraception methods negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1 Exclusion Criteria: More than 24h from the first dose of AB for diagnosed infections (as per inclusion criterion 4) until screening Intravenously administered antibiotics Taking AB in the last 30 days before starting current AB treatment Taking any probiotic or prebiotic supplements in the last 30 days prior to screening Using antidiarrheal medications / enemas on regular basis Multimedication with microbiome-impacting medications within 30 days before enrolment (e.g. proton pump inhibitors antivirals/immunosuppressants, antidepressants) Clinically relevant (as per investigator judgement) self-reported chronic diseases of GI tract (e.g. inflammatory bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, diverticulitis, idiopathic esophageal reflux, malabsorption disorder, severe constipation), urinary tract, reproductive tract (e.g. endometriosis, adenomyosis, pelvic inflammatory disease, uterine fibroids) or metabolic (diabetes (type 1 or Type 2), familial hypercholestraemia, hereditary haemachromatosis) diseases Any form of bowel preparation for endoscopy used in the last 3 months Recent GI surgery (within the last 6 months) Women of child-bearing potential: pregnancy, recently gave birth (within the last 6 months) and/or nursing Recent Covid-19 infection (less than 4 weeks since the first negative SARS-CoV-2 (self) test after the infection) Specific dietary restrictions (e.g. active phase of low Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP) diet) Any dietary mode excluding passage of food via GI tract High intake of alcohol (male subjects > 14 units per week, female subjects, >11 (1 unit corresponds to 360 mL beer, 45 mL spirits (40% alcohol) or 150 mL wine) History of confirmed Clostridium difficile infection in the last 6 months Known allergy or hypersensitivity to any ingredients of the IP Previous adverse reactions to antibiotics Artificial or damaged heart valves History and/or presence of other clinically significant known (self-reported) condition/ disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.: acute pancreatitis immunodeficiency eating disorder recurrent diarrhoea History of or current abuse of drugs or medication Inability to comply with study requirements Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship Participation in another clinical study in the 30 days prior to V1 and during the study
Sites / Locations
- analyze & realize GmbHRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Probiotic
Placebo
Participants in this arm will receive a daily dose of 2x10^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules twice daily, for the duration of antibiotic therapy, and 14 days thereafter.
Participants in this arm will receive an equivalent placebo for the duration of antibiotic therapy, and 14 day thereafter.