Ongoing Clinical Trials for Gastro-oesophageal Reflux Disease
This article provides detailed information about 4 ongoing clinical trials investigating new treatments for gastro-oesophageal reflux disease. These studies are exploring various approaches including medications and dietary interventions for patients across different age groups, from infants to adults, who have not achieved complete symptom relief with standard treatments.
Clinical trial locations
- Belgium
- Denmark
- Poland
Study of prucalopride in patients with gastro-esophageal reflux disease who have incomplete response to standard acid-reducing therapy
This Belgian trial is investigating whether prucalopride can provide additional relief for patients whose reflux symptoms persist despite taking standard acid-reducing medications known as proton pump inhibitors. The study focuses on adults aged 18 to 65 years.
Who can participate: The trial is open to patients who have confirmed reflux disease, either through evidence of inflammation in the food pipe seen during endoscopy or abnormal results on reflux monitoring tests. Participants must have experienced typical reflux symptoms at least three times per week for 12 weeks while taking proton pump inhibitors daily, including at least 8 weeks of twice-daily therapy. Women of childbearing age must use appropriate birth control methods, though oral contraceptives are not permitted due to potential interactions with the study medication.
Who cannot participate: The trial excludes individuals with a history of allergic reactions to prucalopride or similar medications, pregnant or breastfeeding women, and those with other gastrointestinal disorders such as inflammatory bowel disease. Patients with recent major gastrointestinal surgery, severe liver or kidney problems, uncontrolled high blood pressure, significant heart problems, or recent cancer history are also excluded. Those with psychiatric conditions, substance abuse issues, or current participation in other trials cannot join.
Study focus: The trial aims to determine whether adding prucalopride to existing acid-reducing therapy can further decrease acid reflux in patients not fully controlled by standard treatment alone. Participants will take either prucalopride 2 mg tablets or placebo tablets once daily for 4 weeks while continuing their regular acid-reducing medication. The study will measure acid levels through 24-hour monitoring tests and assess how well the food pipe muscles are working. Participants will also complete questionnaires about their symptoms before and after treatment.
Investigational drug: Prucalopride works by improving the movement of food and acid through the digestive system. It stimulates specific serotonin receptors in the digestive tract, which helps reduce reflux symptoms in patients who don’t respond adequately to proton pump inhibitors alone.
Study on Citalopram for Patients with Reflux Hypersensitivity or Functional Heartburn Not Fully Helped by Proton Pump Inhibitors
This Belgian study is exploring the use of citalopram, a medication typically used for depression, in treating specific subtypes of reflux disease called reflux hypersensitivity and functional heartburn. These conditions occur when patients experience heartburn symptoms without typical acid exposure.
Who can participate: Adults between 18 and 65 years old who have experienced typical reflux symptoms at least three times per week for 12 weeks while on proton pump inhibitor treatment are eligible. Participants must have been taking these acid-reducing medications daily for 12 weeks before joining, including at least 8 weeks of twice-daily dosing. Specific test results are required, including an acid exposure time of 4% or less and 80 or fewer reflux episodes during initial monitoring. Sexually active women who can become pregnant must use medically acceptable birth control methods.
Who cannot participate: The trial excludes patients who do not have reflux hypersensitivity or functional heartburn with incomplete response to proton pump inhibitor therapy. Those outside the specified age range and members of vulnerable populations cannot participate.
Study focus: The trial evaluates whether citalopram can effectively reduce symptoms when added to current treatment for patients not fully responding to standard proton pump inhibitor therapy. Participants will take citalopram 20 mg daily for eight weeks. The study will monitor changes in the number and volume of reflux episodes, symptom severity, and how sensitive the food pipe is to reflux. Questionnaires will help assess the impact of treatment on symptoms. The total trial duration is 16 weeks, including treatment and follow-up periods.
Investigational drug: Citalopram increases levels of serotonin, a brain chemical that can help improve mood and potentially influence gut function. By affecting these pathways, researchers hope it may reduce heartburn and discomfort in patients with reflux hypersensitivity or functional heartburn.
Study on the Safety and Effectiveness of Dexlansoprazole for Treating Nonerosive GERD in Children Aged 2 to 11 Years
This Polish trial is studying dexlansoprazole, a delayed-release medication designed to reduce stomach acid in children aged 2 to 11 years who have reflux disease without visible damage to the food pipe.
Who can participate: Children between 2 and 11 years old with a history of reflux symptoms for at least 3 months before the study starts are eligible. The child must have reported symptoms like hurting or burning in the stomach, chest, or throat on at least 3 out of any 7 consecutive days during the screening period, recorded in an electronic diary. Importantly, the child should not have signs of erosive esophagitis, meaning no visible damage to the food pipe. A 24-hour pH test may be used to confirm that symptoms are related to acid. Both boys and girls can participate.
Who cannot participate: Children outside the 2 to 11 age range cannot participate. Those without symptomatic nonerosive reflux disease, those with other medical conditions that might interfere with the study, or those taking medications that could affect study results are excluded. Children who have recently participated in another clinical trial, have allergies to the study medication or similar drugs, or have serious health issues that might make participation unsafe are also excluded.
Study focus: The trial assesses the safety and effectiveness of dexlansoprazole in reducing reflux symptoms in children. Participants will receive the medication in capsule form once daily for 12 weeks. Different doses (15 mg, 30 mg, or 60 mg) will be compared to determine which is most effective. Some participants may receive a placebo. Researchers will monitor the percentage of days without symptoms such as stomach pain, burning sensations, vomiting, and trouble eating. The study aims to understand how to better treat reflux disease across different age groups of children.
Investigational drug: Dexlansoprazole is a proton pump inhibitor that works by blocking acid production in the stomach lining. The delayed-release capsules release the medication slowly over time to provide longer-lasting symptom relief.
Study on Omeprazole and Cow’s Milk-Free Diet for Treating Gastroesophageal Reflux Disease in Infants Under 1 Year
This Danish trial is investigating two different treatment approaches for reflux disease in infants: the medication omeprazole and a cow’s milk-free diet. The study recognizes that some infants with reflux symptoms may also have a cow’s milk allergy.
Who can participate: Infants under 1 year old diagnosed with reflux disease are eligible if they experience at least three reflux episodes daily on average, along with troublesome symptoms such as unexplained crying, discomfort, weight issues, feeding difficulties, breathing pauses, or back-arching. The infant must be older than 1 month at the start of treatment. Both male and female infants can participate.
Who cannot participate: Infants older than 1 year cannot participate. Those who do not have reflux disease or a cow’s milk allergy are excluded, as are infants not part of the specific vulnerable population selected for the study.
Study focus: The trial investigates how well a cow’s milk-free diet or omeprazole works in reducing reflux symptoms in infants under one year of age. Infants will be randomly assigned to one of three groups: a cow’s milk-free diet, omeprazole treatment, or a placebo group. Treatment lasts four weeks. Parents will record the number of reflux episodes and symptoms daily using an app. The study will monitor changes in weight, episodes of visible blood in reflux, crying, feeding refusal, breathing issues, and discomfort. For infants in the diet group, an oral provocation test with cow’s milk will be conducted after four weeks to confirm any milk allergy. The trial is expected to conclude by December 31, 2025.
Investigational treatments: Omeprazole is a proton pump inhibitor that reduces stomach acid production, aiming to decrease the frequency and severity of reflux episodes. The cow’s milk-free diet involves feeding the infant with alternatives to cow’s milk to see if removing these proteins decreases reflux symptoms, particularly in infants who may have an undiagnosed milk allergy.
Summary
These four clinical trials represent diverse approaches to managing gastro-oesophageal reflux disease across different age groups and patient populations. The trials are distributed across three European countries: Belgium, Poland, and Denmark, with Belgium hosting two studies focused on adult patients.
A notable pattern is the focus on patients who have not achieved adequate symptom control with standard proton pump inhibitor therapy. Two trials in Belgium are exploring additional treatment options for adults, investigating prucalopride and citalopram as add-on therapies. These studies recognize that some patients need more than acid suppression alone.
The pediatric population is well-represented, with trials targeting different age groups: infants under 1 year in Denmark and children aged 2 to 11 years in Poland. The infant study is particularly innovative in comparing both dietary intervention and medication, acknowledging the potential overlap between reflux disease and cow’s milk allergy in this age group.
The investigational approaches vary from proton pump inhibitors in children to prokinetic agents and antidepressants in adults, reflecting the growing understanding that reflux disease may require different treatment strategies depending on its underlying causes and the patient’s individual characteristics. These trials may provide valuable insights into personalized treatment approaches for patients across the age spectrum who continue to experience symptoms despite current standard care.
