Not yet recruitingNAINTERVENTIONAL

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

This research study is looking into a new product called Bloat to understand how safe and effective it is for healthy women who suffer from gas and bloating. We want to find out if Bloat can reduce these uncomfortable symptoms after eating, compared to a placebo (a dummy pill with no active ingredients). Participants will take either Bloat or the placebo and then complete questionnaires about their gas and bloating. This will help the researchers compare the effects of Bloat against the placebo. The study aims to gather important information that could potentially lead to new ways to manage common digestive discomfort in women.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Arrae

Enrolment target

100

Start

01 May 2026

Estimated completion

01 Jul 2026

Bloating Gastrointestinal Symptoms Intestinal Gas

What is this study about?

Imagine you often feel gassy or bloated, especially after meals. This study is designed to explore a new product, which for now we're calling 'Bloat,' to see if it could offer some relief. We're looking for healthy women who regularly experience these uncomfortable symptoms.

The main goal is to understand if Bloat can make a real difference in how much gas and bloating you feel an hour after eating, compared to taking a placebo – that's a pill that looks the same but contains no active ingredients. This helps us ensure any changes are due to Bloat itself, not just the expectation of feeling better.

By taking part, you'd be helping scientists gather important information about this new intervention. This kind of research is crucial for developing new and effective ways to manage common digestive issues that many women face.

Key takeaways

This study tests a new product called 'Bloat' for gas and bloating.
It's for healthy women aged 18-65 who often feel bloated.
You'll take either 'Bloat' or a dummy pill (placebo).
You'll share how you feel after taking the dose by answering questions.
The goal is to see if 'Bloat' reduces gas and bloating after eating.
Your participation helps improve understanding of digestive discomfort.

Who may be eligible?

This study is looking for women between 18 and 65 years old. You should regularly experience bloating and/or a swollen tummy at least once a week, and these symptoms should be the main digestive problem you have.

The researchers will also check if you experience significant gas and bloating after eating a standard meal they provide. It's important that you are generally healthy and don't have other serious medical conditions.

If you could become pregnant, you'll need to confirm you're not pregnant at the start of the study and agree to use an approved method of contraception throughout the study period. If you've had certain procedures like a hysterectomy or have been through menopause for at least a year, you wouldn't need contraception.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I a woman between 18 and 65 years old?
Do I experience bloating or a swollen tummy at least once a week?
Are these digestive problems usually my main issue?
Am I generally healthy and don't have other serious health problems?
If I could become pregnant, am I willing to use an approved contraception method?
Am I able to keep my daily habits (like diet) consistent during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to take either a single dose of Bloat or a placebo. You won't know which one you're taking, and neither will the study team – this is called a 'blinded' study and helps make the results fairer. After taking the dose, you'll be asked to fill out questionnaires to describe your feelings of gas and bloating at specific times.

Before you start, the team will check your health and make sure you fit the study criteria. They'll also provide a standard meal to see how your body reacts. You'll be asked to try and keep your usual daily routine, like diet and exercise, as consistent as possible throughout your participation. The exact number of visits will be explained, but the main part involves taking one dose and completing some questionnaires. The total duration of your active involvement in the study is expected to be quite short, mainly focused on that single dose and immediate follow-up.

Potential risks and benefits

Taking part in research like this always involves some potential benefits and risks. A potential benefit is that you might find your gas and bloating symptoms improve if you receive the active Bloat treatment. However, there's no guarantee of benefit, as you might receive the placebo. There may also be unknown side effects from the study product, although it's being tested for safety. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

KGK Science Inc.
Verified postcode
London, Canada

Common questions

What is 'Bloat'?

Bloat is the name for the new product being tested in this study to see if it helps with gas and bloating.

What is a 'placebo'?

A placebo is a dummy pill that looks like the study drug but has no active ingredients. It helps researchers compare the real effects of the study drug.

Will I know if I'm taking Bloat or the placebo?

No, neither you nor the study team will know which you are taking during the study. This helps keep the results unbiased.

How long will I be in the study?

Your active participation, involving taking the dose and answering questions, focuses on a single instance.

What if I get pregnant during the study?

Women who could become pregnant must use a reliable form of birth control throughout the study to avoid pregnancy.

How to find out more

Marc Moulin, PhD

mmoulin@kgkscience.com 2267819094 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.