Clinical Observations on the Effects of a Dietary Supplement (GI Regenerate<sup>TM</sup>) on Patients’ Gastrointestinal Symptoms and Quality of Life Assessments

Background: Different treatments have been developed and used to control symptoms and improve quality of life in patients with digestive diseases and disorders. Although the use of drugs or alternative approaches has improved symptom severity in some but not all patients, often these improvements were not sustainable. Objectives: An open label clinical study was initiated to determine if oral capsules containing a dietary supplement of herbs and oils (GI RegenerateTM) could reduce self-reported gastrointestinal symptoms and improve quality of life (QOL) indicators in patients with gastrointestinal conditions. Methods: Participants included 50 patients (40 females and 10 males) of mean age of 51.1 ± 12.7 years (range, 24 - 77 years) with a diagnosis of a gastrointestinal disorder or gastrointestinal symptoms. These patients consumed five soft-gels containing the test supplement 30 minutes before each meal for 90 days. Symptoms were evaluated by medical staff, and patient health status was self-reported using a validated quality of life questionnaire (Quality of Life Digestive Survey) designed for functional digestive disorders. Exit interviews (Patient Global Impression of Change, PGIC) were conducted by the medical staff. Results: Participants in the study responded with improved symptom severities and QOL scores to the test dietary supplement within the 90 day period; most improvements occurred within 20 days on the test dietary supplement. By the end of the study there were significant overall global improvements in the symptoms and QOL health surveys (p = 0.0183), with significant improvements in symptom discomfort (p = 0.0004), daily activities (p = 0.029) and anxiety (p = 0.018). In contrast, there were insignificant improvements in diet (p = 0.398), sleep (p = 0.136), health perception (p = 0.686), coping with the disease (p = 0.309) and impact of stress (p = 0.785). Using the PGIC exit interview that measured each patient’s impression of overall global change in symptoms and QOL these data also indicated overall significant improvements in symptoms and in satisfaction with the test supplement (moderately better improvements in symptoms and QOL or score of 4.8 ± 0.169, p < 0.0001). There were no significant differences in the responses between males and females, and no significant differences between older (>50 years) versus younger (<50 years) subjects. There were also no safety issues that arose during the trial. Conclusions: The GI RegenerateTM natural dietary supplement safely and significantly reduced gastrointestinal symptoms and improved quality of life in subjects with a broad spectrum of gastrointestinal disorders and symptoms.