This study is being done to assess the effects of S. boulardii CNCM I-745 compared to placebo on impaired intestinal permeability, which is the control of material passing from inside the gastrointestinal tract through the cells lining the gut wall into the rest of the body.
This placebo-controlled parallel group clinical study in healthy adults from the general population aims to investigate whether oral supplementation with S. boulardii CNCM I-745 could strengthen the intestinal barrier function and counteract the acute NSAID-induced hyperpermeability. Indomethacin will be used short term to increase intestinal permeability. The primary objective of the study is to assess the effects of S. boulardii CNCM I-745 on this impaired intestinal permeability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
56
Immediate release oral capsules 50 mg, 3 times a day for 6 days
Two 250 mg capsules orally twice daily for 14 days
Two 250 mg capsules that contains no active study ingredient orally twice daily for 14 days
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGPermeability assays
Change in intestinal permeability parameters urinary lactulose and 13C (13carbon) mannitol in 0-2 hrs, 2-8 hrs, 8-24 hr urine collection
Time frame: Baseline, 2 hrs, 8 hrs, 24 hours
Change in serum zonulin
Circulating zonulin will be measured by ELISA (Immundiagnostik AG) reported in ng/mL
Time frame: Baseline, after intervention approximately 14 days
Change in serum claudin
Serum Claudin 1, 2, 3, 4, 5 and 8 will be measured by ELISAs (Enzyme-Linked Immunosorbent Assay)
Time frame: Baseline, after intervention approximately 14 days
Change in fecal calprotectin
Measured by ELISAs (Enzyme-Linked Immunosorbent Assay) from fecal samples reported in micrograms per milligram (μg/g)
Time frame: Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)
Change in serum C-reactive protein (CRP)
Measured by immuno-turbidimetric assay on an automated clinical chemistry analyzer reported in mg/L
Time frame: Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)
Change in Gastrointestinal Symptom Rating Scale (GSRS) scores
Measured by validated disease-specific questionnaire Gastrointestinal Symptom Response Scale (GSRS) used to evaluate common symptoms of gastrointestinal disorders. 15-item self-reported questionnaire related to signs and symptoms experienced by the subject during the past week, each rated on a seven-point Likert scale from no discomfort (score = 1) to very severe discomfort (score = 7). Total score is comprised between 15 and 105;
Time frame: Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)
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