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A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Gas and Bloating in Healthy Women

ConditionsBloatingGastrointestinal SymptomsIntestinal Gas
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorArrae

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Females aged 18-65 years, inclusive

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,

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

Disqualifiers

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

Participants residing in the same household as another study participant unless they are enrolled consecutively (e.g. not actively enrolled at the same time)

Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of IP, placebo, or standardized meal ingredients

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) as assessed by the QI

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bloat

    Dietary supplement

    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.

  • Placebo

    Other intervention

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: BloatExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arrae

Lead sponsor

KGK Science Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: