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NCT05603416
Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects
Conditions: Healthy Volunteers
Sex: All
Ages: 25 Years – 70 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 30
Sponsor: Vital Solutions GmbH
Location: Germany
Summary
To determine the relief of GI discomfort after overfeeding with a high caloric meal.
Eligibility Criteria
Inclusion Criteria:Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.Age ≥ 25 and ≤ 70 yearsBMI: 19-30 kg/m2Overall GI discomfort after high caloric meal of at least 5 on the VAS scaleMale or femaleWritten consent to participate in the studySubject is able and willing to follow the study protocol proceduresIf applicable, stable intake of chronic medication of at least 3 monthsExclusion Criteria:Criteria for inclusion:Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.Age ≥ 25 and ≤ 70 yearsBMI: 19-30 kg/m2Overall GI discomfort after high caloric meal of at least 5 on the VAS scaleMale or femaleWritten consent to participate in the studySubject is able and willing to follow the study protocol proceduresIf applicable, stable intake of chronic medication of at least 3 monthsCriteria for exclusion:Relevant history, presence of any medical disorder (e.g.
cancer, severe liver disease, severe renal disease, severe cardiovascular disease)Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or use of PPI (proton pump inhibitors) or other digestive auxiliaries potentially interfering with this study at screeningIntake of antibiotics in the last 4 weeksWomen suffering from distinct PMS symptomsAcute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeksChange of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)Vegetarian or vegan nutrition stylePregnant subject or subject planning to become pregnant during the study; breast-feeding subject.Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical studySubject who according to the study staff's opinion is not suitable for participation in the study
Source: ClinicalTrials.gov (NCT05603416). StuddyBuddy aggregates publicly available trial information.