Ongoing Clinical Trials for Dyspepsia
This article provides information about 6 ongoing clinical trials investigating new treatments for dyspepsia. These studies are testing various medications and approaches, including antacids, herbal medicines, and strategies to reduce the use of proton pump inhibitors. Trials are currently taking place in Belgium, Germany, Greece, and Spain.
Clinical trial locations
- Belgium
- Study on Budesonide and Mannitol for Treating Inflammation in Patients with Functional Dyspepsia
- Study on Reducing Proton Pump Inhibitor Use in Patients with Heartburn, Reflux, or Dyspepsia: Comparing On-Demand Use, Alginate Therapy, and Gradual Dose Reduction
- Study on the Effects of Rikkunshito on Functional Dyspepsia in Primary Care Patients
- Germany
- Greece
- Spain
Safety Study of Almagate for Pregnant Women with Heartburn and Reflux, Assessing Effects on Mother and Baby
This trial is evaluating the safety of almagate, an antacid medication, specifically for pregnant women experiencing heartburn and reflux. The study focuses on pregnant women between 18 and 45 years old who are suffering from these common pregnancy-related digestive symptoms.
Inclusion criteria: Participants must be adult women aged 18-45 who are currently pregnant and experiencing heartburn, which is a burning feeling in the chest or throat.
Exclusion criteria: Men, non-pregnant women, and those not experiencing heartburn or reflux symptoms cannot participate in this study.
Main focus: The primary goal is to assess the safety of almagate for both mother and baby during pregnancy. Researchers will monitor various factors including the type of delivery, birth weight and length, overall newborn health, and long-term developmental outcomes. The study will also evaluate maternal satisfaction with the treatment. Participants will take the medication for up to 14 days and attend regular follow-up visits.
Investigational drug: Almagate (Almax Forte 1.5 g) is an oral suspension that works by neutralizing stomach acid to relieve heartburn and reflux symptoms. It is administered as a liquid taken by mouth.
Study on Budesonide and Mannitol for Treating Inflammation in Patients with Functional Dyspepsia
This Belgian study is investigating whether budesonide, a corticosteroid medication, can help reduce inflammation in the small intestine of patients with functional dyspepsia. The trial specifically targets inflammation in the duodenum, the first part of the small intestine.
Inclusion criteria: Participants must be between 18 and 70 years old and have functional dyspepsia with meal-related symptoms, known as postprandial distress syndrome, according to Rome IV diagnostic criteria. Both men and women can participate.
Exclusion criteria: The study excludes patients with other significant health problems, those taking medications that might interfere with results, recent surgery patients, pregnant or breastfeeding women, those with severe allergies to medications, people who cannot follow study procedures, recent participants in other trials, those with substance abuse history, certain mental health conditions, and those under 18 or over 65.
Main focus: The study aims to observe changes in the number of eosinophils (a type of white blood cell) in the duodenum, which are linked to inflammation. Researchers will also assess changes in digestive symptoms, quality of life, mental health status, stomach function, and how quickly the stomach empties. The treatment period lasts 8 weeks.
Investigational drug: Budesonide is administered as Jorveza 1 mg orodispersible tablets, which dissolve in the mouth. It works by reducing inflammation and immune responses in the digestive tract.
Study on the Effects of Rikkunshito on Functional Dyspepsia in Primary Care Patients
This trial is testing Rikkunshito (TJ-43), a traditional Japanese herbal medicine, for treating functional dyspepsia in primary care settings in Belgium. The study compares the herbal treatment with a placebo over a 16-week period.
Inclusion criteria: Participants must be 18 years or older with a new diagnosis of functional dyspepsia according to Rome Criteria. They should experience moderate bothersome fullness after eating or feeling full quickly for 2 to 5 days per week. Participants must provide written consent, understand study requirements, and use effective birth control methods.
Exclusion criteria: Patients not experiencing functional dyspepsia, those outside the specified age range, and vulnerable populations are excluded.
Main focus: The study evaluates whether Rikkunshito can effectively reduce symptoms of functional dyspepsia. Participants will complete daily symptom diaries using the Leuven Postprandial Distress Scale throughout the 8-week treatment period, following a 2-week run-in phase. Researchers will also assess quality of life, anxiety, depression, and changes in duodenal mucosal parameters.
Investigational drug: Rikkunshito is administered as oral granules. It is believed to work by enhancing gastric motility and increasing the release of digestive hormones.
Study on the Effectiveness and Safety of Betaine Citrate for Treating Functional Dyspepsia in Adults
This Greek study is evaluating ALKACITRAT, containing betaine citrate, for treating functional dyspepsia. The trial compares the medication with a placebo to determine its effectiveness and safety.
Inclusion criteria: Men and women aged 18-75 who have symptoms of functional dyspepsia meeting Rome IV criteria, with a GOS (Global Overall Symptom) score of 4 or higher. Participants must be legally competent, understand the study information, and voluntarily agree to participate by signing informed consent.
Exclusion criteria: Pregnant or breastfeeding women, those with severe medication allergies, current participants in other trials, patients with serious heart, liver, or kidney conditions, history of alcohol or drug abuse, uncontrolled mental health disorders, previous stomach surgery, and those unable to follow study procedures are excluded.
Main focus: The study aims to evaluate symptom improvement measured by changes in GOS scores and quality of life assessments using the NDI-SF index. Researchers will track symptom severity and monitor for any adverse events throughout the treatment period.
Investigational drug: ALKACITRAT is an oral solution with 2 grams per tablet dosage. It works as an antacid, neutralizing stomach acid to alleviate stomach irritation, discomfort, and bloating.
Study on Juniper Berry Oil for Digestive Issues like Cramps, Gas, and Bloating in Adults
This German trial is investigating Roleca Wacholder 100mg, containing juniper berry oil, for treating dyspeptic digestive complaints including cramps, flatulence, and bloating. The study compares the herbal treatment with a placebo over up to 12 weeks.
Inclusion criteria: Participants must be between 18 and 59 years old with ongoing dyspeptic digestive symptoms for the past 3 months, including cramps, gas, and bloating. They must experience at least mild discomfort, pressure, and fullness in the upper abdomen. Women of childbearing potential need a negative pregnancy test and must agree to use reliable contraception. All participants must sign informed consent.
Exclusion criteria: Those under 18, pregnant or breastfeeding women, patients with known allergies to study ingredients, current participants in other trials, those with severe medical conditions or recent digestive surgery, history of substance abuse, and those unable to follow study procedures are excluded.
Main focus: The study evaluates how effective juniper berry oil is in relieving digestive symptoms using the Nepean Dyspepsia Index. Participants will keep symptom diaries throughout the treatment period. Researchers will assess safety, tolerability, medication compliance, and analyze changes in the intestinal microbiome before and during treatment.
Investigational drug: Roleca Wacholder is administered as 100mg soft capsules taken orally. The juniper-derived active ingredients are believed to reduce gastrointestinal spasms and gas formation.
Study on Reducing Proton Pump Inhibitor Use in Patients with Heartburn, Reflux, or Dyspepsia: Comparing On-Demand Use, Alginate Therapy, and Gradual Dose Reduction
This Belgian study focuses on finding the best way to help patients stop using proton pump inhibitors (PPIs) who have been taking them long-term without a clear medical reason. The trial compares three different strategies for discontinuing PPIs.
Inclusion criteria: Adults over 18 years old, both male and female, who have been using PPIs daily for more than 12 weeks without a specific medical reason for long-term use can participate.
Exclusion criteria: Patients with functional dyspepsia, those experiencing heartburn, or those with reflux are excluded from this study.
Main focus: The study compares three approaches: on-demand PPI use (taking medication only when symptoms occur), replacement with alginate formulation (containing sodium hydrogen carbonate, calcium carbonate, and sodium alginate), and gradual dose reduction through a fixed schedule. Researchers will evaluate which method is most effective by measuring successful outcomes, including reduced PPI use, patient satisfaction, and willingness to continue treatment. The study runs until August 2025.
Investigational drugs: PPIs reduce stomach acid production and are taken orally as tablets or capsules. The alginate formulation works differently by forming a protective barrier on top of stomach contents, preventing acid from flowing back into the esophagus.
Summary
These six clinical trials demonstrate diverse approaches to treating dyspepsia and related digestive conditions. Belgium is notably active in this research area, hosting three of the six trials, while Germany, Greece, and Spain each host one study. The trials reflect different therapeutic strategies, from traditional medications like antacids and corticosteroids to herbal medicines such as juniper berry oil and Rikkunshito.
Several studies focus on functional dyspepsia, particularly exploring anti-inflammatory approaches and treatments for specific symptom patterns like postprandial distress syndrome. One study uniquely addresses the needs of pregnant women with heartburn. Another takes a practical approach by investigating how to safely reduce long-term PPI use in patients who may no longer need these medications.
The trials use various outcome measures, including symptom severity scales, quality of life assessments, and in some cases, examination of inflammation markers and intestinal microbiome changes. Treatment durations range from 8 to 16 weeks, with most studies comparing active treatments against placebo to establish effectiveness.
