To determine the relief of GI discomfort after overfeeding with a high caloric meal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
30
oral dissolvable powder - dosage 300mg
oral dissolvable powder - dosage 300mg no active ingredient
Biotesys GmbH
Esslingen am Neckar, Germany
Overall gastrointestinal discomfort assessed with a visual analogue scale (VAS)
In the current study, GI discomfort, following a high caloric meal, will be assessed with a visual analogue scale (VAS) before and after meal at defined timepoints.
Time frame: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)
Assessment of gastrointestinal symptoms on a 6-point Likert scale
In the current study, the following GI symptoms will be assessed: Feeling of fullness / tension, Passage of gas/ Flatulence, Bloating, GI discomfort, cramps, pain, Rumbling, Burping, Heartburn symptom, Nausea, Urge of defecate
Time frame: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)
Follow up assessment of gastrointestinal symptoms on a 6-point Likert scale
In the current study, the following GI symptoms will be assessed: Feeling of fullness / tension, Passage of gas/ Flatulence, Bloating, GI discomfort, cramps, pain, Rumbling, Burping, Heartburn symptom, Nausea, Urge of defecate, as well as overall gastrointestinal discomfort.
Time frame: Day 1 immediately prior going to bed, day 2 immediately after wake up
Monitoring of related adverse events
Reporting of adverse effects to evaluate tolerability
Time frame: up to 14 hours after intake
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