At a glance
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Clinical Study on the Effects of the Product Mucosave® on Gastrointestinal Discomfort and the Quality of Life in Healthy Volunteers
In Brief
A clinical study evaluating Mucosave® capsules and Placebo for Gastrointestinal Discomfort. Completed, enrolled 100 participants across 1 site.
Detailed Summary
Gastrointestinal (GI) discomfort, which often includes gastroesophageal reflux disease (GERD) is a common disorder in healthy adults affecting 20% of people particularly women. The disorders related to GI discomfort usually have a huge impact on the quality of life. Current treatment for GERD are associated with side effects. In this study, researchers designed a randomized double-blind placebo-controlled trial to assess the effect of Mucosave® on the symptoms and quality of life of healthy adults with gastrointestinal discomfort. One hundred healthy subjects with GI discomfort were enrolled in the study and divided in two groups: 60 and 40 taking for 8 weeks Mucosave® (400 mg/day) or placebo (400 mg/day). To evaluate the effects of treatment, the questionnaires Gastrointestinal Quality of Life index (GIQLI) and GERD Symptom Assessment Scale (GSAS) were self-administered by participants before the beginning of period of supplementation (T0), after four weeks (T4) during the period of supplementation and after 8 weeks (T8) at the end of supplementation.
Study Details
Timeline
Interventions
400 mg/day of Mucosave® capsules for a period of 8 weeks, once a day.
400 mg/day of placebo capsules for a period of 8 weeks, once a day.