Alginate and lifestyle changes in gastro-oesophageal reflux disease
This study is looking for adults aged 18-70 who suffer from regular heartburn and indigestion, known as GORD. It aims to compare two different ways of managing these symptoms. One group will receive a common medicine called omeprazole, which reduces stomach acid. The other group will try an alginate gel, which helps block acid reflux, combined with personalised advice on diet and lifestyle from a dietitian. The project wants to see if changing lifestyle alongside alginate treatment can be as effective as omeprazole, especially given growing concerns about long-term use of acid-reducing medicines. By taking part, you could help improve how GORD is treated in the future.
At a glance
What is this study about?
This research study is looking at adults between 18 and 70 years old who experience ongoing heartburn and indigestion, a condition called Gastro-Oesophageal Reflux Disease (GORD). Many people with GORD are prescribed a type of medicine known as proton pump inhibitors (PPIs), such as omeprazole, which are usually very effective at reducing stomach acid and symptoms. However, doctors are becoming more aware of potential issues if these medicines are taken for a very long time.
We know that things like what we eat, our weight, smoking, and drinking alcohol can make acid reflux worse. This study wants to find out if taking an alginate medicine – which works by neutralising stomach acid and forming a protective layer – along with getting proper advice on healthy eating and lifestyle changes, can work just as well as PPI medication in controlling reflux symptoms. The main goal is to improve the comfort of people with GORD.
Ultimately, the results of this study could be very important. If the combination of alginate and lifestyle changes proves effective, it could offer a new way for doctors to help people manage their GORD, potentially reducing the need for long-term PPI use. This could lead to new best practices for treating this common condition.
Key takeaways
- The study compares a common acid reflux medicine (omeprazole) with alginate gel plus diet advice.
- It aims to find new, potentially safer ways to manage GORD for the long term.
- Participation involves 6 visits (3 remote, 3 in-person) over 6 months.
- You'll be randomly assigned to one of two treatment groups.
- Benefits include regular health monitoring; risks relate to treatment side effects and a few specific tests.
- The study runs from May 2025 to March 2027 and is for people aged 18-70 with GORD.
Who may be eligible?
To be considered for this study, you need to be an adult between 18 and 70 years old and have a confirmed diagnosis of Gastro-Oesophageal Reflux Disease (GORD), meaning you have regular heartburn and indigestion symptoms.
Specifically, during a one-week check-up period, you must report having heartburn or regurgitation (acid coming back up) on at least three days. While some discomfort is expected, you shouldn't have very severe heartburn or regurgitation on more than two days in total during this week, and any indigestion symptoms should be mild.
If you are a woman who could become pregnant, you'll need to have a negative pregnancy test at the start of the study. You must also agree to use an approved method of contraception throughout the study and for one month after your last dose of study medication.
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 70 years old?
- Do you experience heartburn or indigestion regularly (GORD)?
- Did you have heartburn or acid coming back up on at least 3 days in the past week?
- If you could become pregnant, are you willing to use effective contraception throughout the study?
What does participation involve?
If you decide to take part, you'll be involved in the study for six months. During this time, you will have a total of six appointments: three will be done remotely (for example, by phone or video call) and three will require you to visit the clinic in person.
Participants will be placed into one of two groups by chance. One group will take omeprazole, a medicine that reduces acid production in the stomach. The other group will take an alginate medicine, which helps neutralise stomach acid and forms a barrier to stop reflux, along with receiving regular support and advice on diet and lifestyle from a dietitian.
The main aim is to see how much your heartburn and indigestion improve after four weeks, which will be measured using a questionnaire. If your symptoms don't improve after four weeks, you'll receive further medical investigations. If they do improve, you'll continue with your assigned treatment and be monitored for the remaining five months.
Potential risks and benefits
Locations (2)
- The Functional Gut Clinic LondonApproximateLondon, England
- The Functional Gut Clinic ManchesterCity onlyManchester, England
Common questions
What is GORD?
GORD stands for Gastro-Oesophageal Reflux Disease. It's a common condition where stomach acid frequently flows back up into the gullet (oesophagus), causing symptoms like heartburn and indigestion.
What is omeprazole?
Omeprazole is a common medicine called a Proton Pump Inhibitor (PPI). It works by significantly reducing the amount of acid your stomach produces.
What is alginate?
Alginate is a type of medicine that helps to neutralise stomach acid and forms a protective layer, often called a 'raft', to prevent stomach contents from flowing back up into your gullet.
How long will I be in the study?
If you participate, you will be in the study for a total of six months.
Who is paying for this study?
The study is funded by Reckitt Benckiser Health Limited, a company that produces health-related products.
How to find out more
Sam Treadway
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.