Bloating, Gastrointestinal Symptoms, Intestinal Gas
Conditions
Keywords
Bloat, Arrae, Bloating, Intestinal Gas, Gastrointestinal symptoms
Brief summary
The goal of this clinical trial is to investigate the safety and efficacy of Bloat on postprandial bloating in healthy women. The main question it aims to answer is what is the difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo, as assessed by the bloating numeric rating scale at screening/baseline. Participants will be asked to consume one dose of Bloat or Placebo for 55 days, and answer questionnaires on gas, bloating, and abdominal discomfort/distension.
Interventions
DIETARY_SUPPLEMENTBloat
Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.
OTHERPlacebo
Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.
Sponsors
Arrae
KGK Science Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Females aged 18-65 years, inclusive 2. BMI of 18.5 to 29.9 kg/m2, inclusive 3. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least one year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of 3 months. Acceptable methods of birth control include: * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) * Double-barrier method * Intrauterine devices * Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s) * Vasectomy of partner at least 6 months prior to screening * Abstinence and agrees to use contraception if planning on becoming sexually active during the study 4. Recurrent bloating and/or distension occurring on average at least one day per week which predominates over other GI symptoms in the previous three months, as assessed by the QI 5. Experiences significant bloating after consumption of the standardized meal provided at screening/baseline, as assessed by a score of ≤ 2 pre-meal and a score of ≥ 5 post-meal 6. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 7. Provided voluntary, written, informed consent to participate in the study 8. Healthy as determined by medical history as assessed by QI
Exclusion criteria
1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study 2. Participants residing in the same household as another study participant unless they are enrolled consecutively (e.g. not actively enrolled at the same time) 3. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of IP, placebo, or standardized meal ingredients 4. Current or history of any significant diseases of the GI tract or digestive disorders (e.g., irritable bowel syndrome, celiac disease, inflammatory bowel disease, functional constipation, gastroesophageal reflux disease, being treated within the past year for H. pylori infection or gastric ulcer), use of medications that inhibit peristaltic movement (e.g., opioids, loperamide), esophageal obstruction, or difficulty swallowing, as assessed by the QI 5. Individuals with anemia, gallstones, or gallbladder disease as assessed by the QI 6. Unstable metabolic disease or chronic diseases as assessed by the QI 7. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI 8. Type I or Type II diabetes 9. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis 10. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months 11. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI 12. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI 13. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable 14. Individuals with an autoimmune disease or are immune compromised as assessed by the QI 15. Chronic use of cannabinoid products (\>2 times/week) as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period 16. Regular use of tobacco or nicotine products in the past 6 months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period 17. Alcohol intake average of \>2 standard drinks per day as assessed by the QI 18. Alcohol or drug abuse within the last 12 months 19. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the IP (Section 7.3) 20. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI 21. Individuals who are unable to give informed consent 22. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo | Day 1 to Day 56 | The difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo, as assessed by the bloating numeric rating scale at screening/baseline. On a scale from 0 to 11, with 0 being 'none' and 10 being 'most I have ever experienced'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference in change in bloating from pre-dose (postprandial) at t = 30 mins post-dose (postprandial) and t = 120 mins post-dose (postprandial) between Bloat and placebo | Day 1 to Day 56 | The difference in change in bloating from pre-dose (postprandial) at t = 30 mins post-dose (postprandial) and t = 120 mins post-dose (postprandial) between Bloat and placebo, as assessed by bloating numeric rating scale at screening/baseline. On a scale from 0 to 11, with 0 being 'none' and 10 being 'most I have ever experienced'. |
| The difference in change in gas from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo | Day 1 to Day 56 | The difference in change in gas from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo, as assessed by the gas numeric rating scale at screening/baseline. On a scale from 0 to 11, with 0 being 'none' and 10 being 'most I have ever experienced'. |
| The difference in change in abdominal discomfort from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo | Day 1 to Day 56 | The difference in change in abdominal discomfort from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo, as assessed by the abdominal discomfort numeric rating scale at screening/baseline. On a scale from 0 to 11, with 0 being 'none' and 10 being 'most I have ever experienced'. |
| The difference in change in GI symptoms from baseline at Day 28 and Day 56 between Bloat and placebo | Day 1 to 56 | The difference in change in GI symptoms from baseline at Day 28 and Day 56 between Bloat and placebo, as assessed by PROMIS-GI Gas and Bloating Scale. All items are administered using a 5-point categorical response scale. |
| The difference in change in gas, bloating, and abdominal distention scores | Day 1 to Day 56 | The difference in change in gas, bloating, and abdominal distention scores as assessed weekly by the gas, bloating, and abdominal distension numeric rating scales. Participants will be instructed to complete 11-point numeric rating scales from 0 ('none') to 10 ('most I have ever experienced') |
| The difference in change in waist circumference from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo | Day 1 to Day 56 | The difference in change in waist circumference from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo at screening/baseline |
Countries
Canada
Contacts
CONTACTMarc Moulin, PhD
PRINCIPAL_INVESTIGATORDavid Crowley, MD
KGK Science Inc.
Outcome results
None listed