RecruitingNAINTERVENTIONAL

Visible Abdominal Distension

Do you suffer from tummy bloating that you can actually see? This research is exploring a new, easy-to-learn technique called biofeedback to help manage this. Many people experience bloating, especially if they have conditions like Irritable Bowel Syndrome (IBS) or indigestion. Current biofeedback methods can be complicated, so this study aims to see if a simpler version, taught through a training programme, can be effective. Participants will learn how to control certain tummy muscles to reduce bloating, or they will be in a group receiving a dummy treatment. We want to find out if this simple approach works across different hospitals and clinics. It's for adults aged 18 to 80 who have visible bloating often triggered by meals.

At a glance

Status

Recruiting

Phase

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrolment target

100

Start

30 Jul 2025

Estimated completion

01 Oct 2026

Irritable Bowel Syndrome Dyspepsia Functional Bloating

What is this study about?

This study is investigating a common and often uncomfortable problem: visible bloating of the tummy. Many people experience this, particularly those with conditions like Irritable Bowel Syndrome (IBS), indigestion (dyspepsia), or general tummy discomfort without a clear cause. This bloating often happens because of how the body's muscles around the tummy area are working.

Researchers have previously found that a technique called biofeedback can help. This involves learning to control certain body functions, often with the help of special equipment. However, the existing biofeedback methods for bloating can be quite complex and difficult to use in everyday life. So, this new study aims to make it much simpler and more accessible.

Now, the team wants to see if a new, easy-to-learn biofeedback method can be just as good. This new technique doesn't need special machines; instead, it's taught through a standard training programme. The goal is to prove that this simpler version effectively helps people reduce their visible tummy bloating, and that it can be taught and used successfully in different healthcare centres across the country. By making it less complicated, more people might benefit from this treatment.

Key takeaways

This study tests a simple biofeedback method for visible tummy bloating.
It's for adults aged 18-80 with bloating, especially after meals.
You'll either learn exercises or take a dummy pill.
The total participation time is about seven weeks.
The aim is to find an easier way to manage bloating without complex equipment.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged between 18 and 80 years old, both men and women, who experience visible bloating of their tummy. This bloating should typically be noticed after you've eaten a meal.

However, there are some reasons why you might not be able to join. You can't take part if a doctor has found a clear medical reason for your bloating after checking you over. Also, if you regularly get constipated, this study isn't suitable for you. Finally, if your bloating isn't consistently confirmed over a week before the study starts, you wouldn't be able to participate.

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.

Are you between 18 and 80 years old?
Do you experience visible bloating in your tummy?
Does your bloating often happen after you eat?
Has a doctor ruled out other serious medical reasons for your bloating?
Do you generally not suffer from constipation?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be put into one of two groups by chance: either the biofeedback group or the placebo (dummy treatment) group. For the first three weeks, you'll have three short sessions. If you're in the biofeedback group, a trained person will teach you exercises using a special video to help you control your tummy muscles. You'll then be asked to do these exercises at home, before and after every meal, for the next four weeks.

If you're in the placebo group, you'll have sham (fake) measurements of your tummy movement, and you'll be given a harmless sugar pill. You'll be asked to take this pill before and after every meal for the next four weeks. There will be some questionnaires to fill out during the study to check your bloating. The total time you'll be actively doing study-related tasks is about seven weeks.

Potential risks and benefits

Participating in this study might offer you a chance to learn skills to manage your visible bloating, potentially improving your comfort and quality of life, even if you are in the placebo group and a placebo effect helps. The biofeedback exercises are generally safe and non-invasive, meaning there are very few risks expected. The main commitment is your time and effort in attending sessions and doing exercises or taking pills as instructed. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

G. Oppenheimer Center for Neurobiology of Stress and Resilience
Verified postcode
Los Angeles, United States· Recruiting
McMaster University
Verified postcode
Hamilton, Canada· Recruiting
Bordeaux University Hospital
Verified postcode
Bordeaux, France· Active not recruiting
Santa Orsola Hospital
Verified postcode
Bologna, Italy· Active not recruiting
Hospital Universitari Vall d'Hebron
Verified postcode
Barcelona, Spain· Not yet recruiting
Sahlgrenska Hospital, Gothenburg
Verified postcode
Gothenburg, Sweden· Active not recruiting
Manchester University
Verified postcode
Manchester, United Kingdom· Active not recruiting

Common questions

What is biofeedback?

Biofeedback helps you learn to control your body's functions, like muscle activity, by being aware of them. In this study, it's about learning to control tummy muscles.

What is 'visible abdominal distension'?

It means your tummy bloating is noticeable and you can actually see it, rather than just feeling bloated inside.

What's a 'placebo'?

A placebo is a dummy treatment, like a sugar pill or fake exercise, that looks and feels like the real thing but has no active ingredients. It helps us compare the real treatment fairly.

Will I know if I'm getting the real treatment or the placebo?

No, you won't know which group you're in. This is called 'blinding' and it's important for ensuring the study results are fair and unbiased.

How long will I need to be involved?

The main part of your involvement will be over about seven weeks, including three initial sessions and four weeks of daily tasks.

How to find out more

Fernando Azpiroz, MD

azpiroz.fernando@gmail.com 34 932746259 Official trial record

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