Bloat Gummies for Digestive Health

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arrae

Must not be taking: Digestive enzymes, Probiotics, Antacids, Opioids

Disqualifiers: GI diseases, Cancer, Neurological disorders, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day per crossover period

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this crossover clinical trial is to evaluate the efficacy and safety of Bloat Gummies on postprandial bloating and related gastrointestinal discomfort in healthy adults with recurrent bloating. The main question it aims to answer is whether Bloat gummies reduce post-meal bloating, gas, or abdominal pain (stomach) discomfort. Participants will be asked to consume one dose of Bloat or Placebo after 2 test meals and answer questionnaires on gas, bloating and abdominal distension.

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing to complete online surveys and at-home measurements (waist circumference) at scheduled time points

Provides voluntary, written, informed consent to participate in the study prior to any study procedures

I agree to keep my current lifestyle habits during the study.

Exclusion Criteria

I do not have any serious or untreated medical or psychiatric conditions.

Wear dentures

Any other condition that, in the Investigator's opinion, may adversely affect the participant's ability to complete the study or its measures, or that may pose significant risk to the participant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume one dose of Bloat or Placebo after 2 test meals and answer questionnaires on gas, bloating, and abdominal distension

1 day per crossover period

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bloat Gummies

How Is the Trial Designed?

Group I: Bloat Gummy Experimental Treatment 1 Intervention

Bloat is a gummy that contains the active ingredients ginger root extract, lemon balm extract, dandelion root extract and the postbiotic HTES1, Bifidobacterium longum CECT7347.

Group II: Placebo Gummy Placebo Group 1 Intervention

The placebo is a gummy that looks and tastes like the study gummy, but with no active ingredients.

Who Is Running the Clinical Trial?

Arrae

Lead Sponsor

Trials

1

Recruited

40+