Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Health… (NCT05603416) | Clinical Trial Compass
UnknownNot Applicable
Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects
Germany30 participantsStarted 2022-11-09
Plain-language summary
To determine the relief of GI discomfort after overfeeding with a high caloric meal.
Who can participate
Age range
25 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
* Age ≥ 25 and ≤ 70 years
* BMI: 19-30 kg/m2
* Overall GI discomfort after high caloric meal of at least 5 on the VAS scale
* Male or female
* Written consent to participate in the study
* Subject is able and willing to follow the study protocol procedures
* If applicable, stable intake of chronic medication of at least 3 months
Exclusion 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 years
* BMI: 19-30 kg/m2
* Overall GI discomfort after high caloric meal of at least 5 on the VAS scale
* Male or female
* Written consent to participate in the study
* Subject is able and willing to follow the study protocol procedures
* If applicable, stable intake of chronic medication of at least 3 months
Criteria 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 screening
* Intake of antibiotics in the last 4 weeks
* Women suffering from distinct PMS sympt…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall gastrointestinal discomfort assessed with a visual analogue scale (VAS)
Timeframe: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)