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 range18 Years – 65 Years

SexALL

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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
✕. 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

What they're measuring

Change in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)

Timeframe: Baseline (V1), Day 6 - 11 (V2)

Trial details

NCT IDNCT05845073

SponsorThe Archer-Daniels-Midland Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-25

View on ClinicalTrials.gov More Antibiotic-associated Diarrhea trials