For a study, patients with functional GI symptoms aged 18 to 75 years old were eligible to participate in a single-arm, open-label, multicenter research (NCT04155801). The unique probiotic combination was given once a day for 30 days as an oral capsule. Patient-reported improvement in total GI well-being at day 30 was the primary efficacy goal. As measured by the GI Health Symptom Questionnaire, changes in GI symptoms were used as secondary efficacy goals. At each visit, several treatment-related adverse events were reported. About 72.3% of the 188 patients enrolled were female, with a mean (SD) age of 44.1 (13.4) years. At the end of day 30, 85.1% of patients had achieved the primary goal, a good response indicating improved overall GI health. On day 30, 75.8% and 87.3% of patients reported improvements from baseline in diarrhea frequency (baseline frequency≥3 to 4 d/wk) and severity (baseline severity≥5/10). Constipation frequency (baseline frequency≥3 to 4d/wk) and severity (baseline severity≥5/10) improved in 73.6% and 80.4% of patients, respectively, over the same period. The majority of patients reported decreased frequency and intensity of straining, urgency, stomach pain/discomfort, bloating, and distention by day 30. On day 14, the improvements described on day 30 were generally visible. There were no warning signs discovered. A new 5-strain probiotic effective and safe combination relieved functional GI issues.
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