Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Menthacarin® in the treatment of functional gastrointestinal disorders

This study is about understanding how a treatment called Menthacarin works for common tummy troubles, known as functional gastrointestinal disorders. These are conditions that cause symptoms like tummy pain, bloating, or changes in bowel habits, but without any clear damage inside the gut. Menthacarin is already available, and this study aims to gather more information on how effective it is in real-world use. Researchers will ask participants about their symptoms, how they feel overall, and their quality of life. They will also look at how satisfied people are with the treatment and check for any side effects. This research helps doctors and patients better understand if Menthacarin is a good option for managing these frustrating gut issues.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Dr. Willmar Schwabe GmbH & Co. KG

Enrolment target

Start

30 Mar 2023

functional gastrointestinal disorders

What is this study about?

This study is all about a treatment named Menthacarin and its effects on common gut problems. These problems are often called 'functional gastrointestinal disorders'. This is a long name for conditions where people have uncomfortable symptoms like tummy aches, bloating, constipation, or diarrhoea, even though tests don't show any obvious disease or damage in their digestive system. For many people, these symptoms can be quite disruptive and affect their daily lives.

The main goal of this research is to see how well Menthacarin helps people manage their symptoms. Because Menthacarin is already available, this study is like a detailed check-up to understand its real-world performance. The researchers want to know if it makes a noticeable difference to people's symptoms, how it affects their overall well-being, and if it's well-tolerated.

To do this, participants will be asked to share a lot of information about their experiences. This includes rating their pain and other symptoms, describing their bowel habits, and explaining how the treatment impacts their daily life and their overall satisfaction. They will also keep an eye out for any unwanted effects. This kind of research is really important because it helps us learn more about existing treatments, making sure doctors can give the best advice to patients struggling with these often-frustrating gut conditions.

Key takeaways

This study evaluates Menthacarin for common gut problems.
It aims to understand Menthacarin's real-world effectiveness.
You'll report symptoms, bowel habits, and satisfaction.
Participation involves questionnaires and possibly blood tests.
Both men and women aged 18+ can join.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old or older. There's no upper age limit, meaning older adults are welcome to participate too. Both men and women can join the study, as the treatment is being looked at for everyone.

Key things they'll be looking for include having been diagnosed with a functional gastrointestinal disorder. This means you experience ongoing symptoms like tummy pain, bloating, or changes in how often you go to the toilet, but doctors haven't found any other specific disease causing these problems.

The research team will have a more detailed list of criteria to make sure the study is right for you and that the results are as accurate as possible. It's always best to discuss these with the study doctor or nurse to see if you're a good fit.

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 18 years old or older?
Do you experience symptoms of a functional gastrointestinal disorder (e.g., IBS)?
Have doctors investigated your symptoms and ruled out other gut diseases?
Are you willing to regularly report on your symptoms and experiences?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need to attend lots of hospital visits. This study is mainly about tracking your experience with Menthacarin in your daily life, as it's a treatment that's already out there. You'll likely be asked to regularly rate your symptoms using simple scales. This could involve using a number from 0 to 10 to describe how bad your tummy pain is, or how much your symptoms bother you.

You'll also be asked about your bowel movements, including how often you go and what they look like, perhaps using a chart like the Bristol Stool Scale. There will be questionnaires to fill out about your overall satisfaction with the treatment and how it affects your quality of life. The study might also involve a blood test to check certain markers related to gut health. You'll be asked to report any side effects you experience.

The overall duration of your participation in the study would be discussed with you by the research team, but it primarily involves regular reporting of your symptoms and experiences over a set period.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it helps doctors and other patients understand more about Menthacarin and how it works for functional gastrointestinal disorders, which could ultimately lead to better care for these conditions. For you personally, it might offer a structured way to monitor your symptoms and communicate with healthcare professionals. Potential risks are generally low, as Menthacarin is an existing treatment; however, you might experience side effects, just like with any medication. You will also need to dedicate time to complete questionnaires and potentially have blood tests. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What are 'functional gastrointestinal disorders'?

These are conditions like Irritable Bowel Syndrome (IBS) where you have tummy symptoms such as pain, bloating, constipation, or diarrhoea, but tests don't show any physical problem with your gut.

What is Menthacarin?

Menthacarin is a treatment that is already available, and this study is looking at how it helps people who have functional gut problems.

Will I have to go to hospital for this study?

It's unlikely you'll need many hospital visits. The study mainly involves you reporting your symptoms and experiences from home or during routine check-ups.

Will I get paid to be in the study?

The study information doesn't mention payment for participation. Travel expenses might be covered, but you'd need to confirm this with the study team.

Can I stop being part of the study once I start?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.