The goal of this clinical trial is to investigate the safety and efficacy of Bloat on gas and bloating in healthy women. The main question it aims to answer is what is the change in postprandial gas and bloating from pre-dose at t = 60 mins post-dose between Bloat and placebo, as assessed by Gas and Bloating Likert scale at screening/baseline. Participants will be asked to consume one dose of Bloat or Placebo and answer questionnaires on gas and bloating.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal during the screening/baseline clinic visit.
Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal during the screening/baseline clinic visit
KGK Science Inc.
London, Ontario, Canada
The difference in change in postprandial gas and bloating from pre-dose at t = 60 mins post-dose between Bloat and placebo
The difference in change in postprandial gas and bloating from pre-dose at t = 60 mins post-dose between Bloat and placebo, as assessed by Gas and Bloating Likert scale at screening/baseline. On a scale of 0 to 3, with 0 being "mild" and 3 being "severe".
Time frame: Day 0 to 56
The difference in change in GI symptoms from baseline between Bloat and placebo
The difference in change in GI symptoms from baseline at Day 28 between Bloat and placebo, as assessed by PROMIS-GI Gas and Bloating Scale. On a scale of 0 to 4, with 0 being "no symptoms" to 4 being "severe symptoms"
Time frame: Day 0 to 28
The difference in change in GI symptoms from baseline between Bloat and placebo
The difference in change in GI symptoms from baseline at Day 56 between Bloat and placebo, as assessed by PROMIS-GI Gas and Bloating Scale. On a scale of 0 to 4, with 0 being "no symptoms" to 4 being "severe symptoms"
Time frame: Day 0 to 56
The difference in change in GI symptoms from baseline between Bloat and placebo
The difference in change in GI symptoms from baseline at Day 28 between Bloat and placebo, as assessed by PROMIS-GI Reflux Scale. On a scale of 0 to 4, with 0 being "no symptoms" to 4 being "severe symptoms"
Time frame: Day 0 to 28
The difference in change in GI symptoms from baseline between Bloat and placebo
The difference in change in GI symptoms from baseline at Day 56 between Bloat and placebo, as assessed by PROMIS-GI Reflux Scale. On a scale of 0 to 4, with 0 being "no symptoms" to 4 being "severe symptoms"
Time frame: Day 0 to 56
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The difference in change in GI symptoms from baseline between Bloat and placebo
The difference in change in GI symptoms from baseline at Day 28 between Bloat and placebo, as assessed by PROMIS- GI Belly Pain Scale. On a scale of 0 to 4, with 0 being "no symptoms" to 4 being "severe symptoms"
Time frame: Day 0 to 28
The difference in change in GI symptoms from baseline between Bloat and placebo
The difference in change in GI symptoms from baseline at Day 56 between Bloat and placebo, as assessed by PROMIS- GI Belly Pain Scale. On a scale of 0 to 4, with 0 being "no symptoms" to 4 being "severe symptoms"
Time frame: Day 0 to 56
The difference in change in gas and bloating scores as assessed weekly by the Gas and Bloating Likert scales
The difference in change in gas and bloating scores as assessed weekly by the Gas and Bloating Likert scales. On a scale of 0 to 4, with 0 being "no symptoms" to 4 being "severe symptoms".
Time frame: Day 0 to 56