Cure8 trial brief
Patients and clinicians often seek adjunctive options to improve symptoms, quality of life, or reduce treatment burden. This trial tests whether Bacillus spore probiotics added to standard care can provide measurable clinical or biological benefit in IBD.
Adults with ulcerative colitis or Crohn’s disease, gastroenterology clinicians, clinical researchers studying microbiome or probiotic therapies, and patients interested in probiotic adjuncts.
This is a ClinicalTrials.gov record for a randomized, blinded interventional study testing multi-strain Bacillus spore probiotics (LiveSpo® COLON and LiveSpo® DIA30) as an add-on to standard IBD treatment in adults 18–65.
The trial plans to enroll 150 participants randomized to placebo, COLON, or DIA30→COLON arms and will assess safety and efficacy with clinical visits at baseline, days 7, 14, and 30 and subclinical measures (blood, cytokines, stool PCR for Bacillus species).
Exploratory analyses include microbiome composition and endoscopic findings; the main comparison focuses on change from baseline to day 30.
The study interventions are probiotic product formulations containing Bacillus subtilis, Bacillus clausii, and Bacillus coagulans strains given as oral ampoules three times daily for up to 30 days alongside each participant’s standard IBD care.
Outcomes include clinical symptom scores, quality of life, laboratory/cytokine measures, and detection of probiotic strains in stool. This entry is a trial record (not results).
It describes planned methods and endpoints but does not report findings, so it should not be interpreted as evidence that the probiotics are effective or safe beyond what the trial will test.
This is a trial-record summary from ClinicalTrials.gov describing a study protocol that is not reporting results. Outcomes and safety will depend on future trial conduct and reporting. The intervention is an add-on to participants’ usual IBD treatments; results will be needed before changing clinical care.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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