Study design: A 4-week clinical study of 188 adults who took ENVIVE once daily for 30 days. The primary endpoint was the percentage of participants with a positive end-of-study response for improvement in overall GI well-being. The secondary endpoints comprised outcomes for individual GI symptomatology, intestinal wall permeability, and quality of life. Overall GI well-being and patient satisfaction were evaluated on Day 30. GI symptom severity and frequency were measured at Day 1 (baseline), Day 14, Day 30, and Day 42. Severity was assessed using an 11-point scale (0=none, 10=severe). Frequency was assessed using a 5-point scale (0=never, 5=daily).1
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.