The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms (NCT05845073) | Clinical Trial Compass
CompletedNot Applicable
The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms
Germany69 participantsStarted 2023-05-09
Plain-language summary
This study evaluates the effect of a multistrain probiotic on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Exclusion criteria
. More than 24h from the first dose of AB for diagnosed infections (as per inclusion criterion 4) until screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
. 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