Can a capsule calm the Post-Meal stomach blues?
NCT ID NCT05199441
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial tests whether a capsule called Galeo (dihydroxydibutylether) can ease the bloating, fullness, and nausea that some people feel after eating, a condition known as postprandial distress syndrome. About 226 adults with this condition will take either Galeo or a placebo for 4 weeks. Researchers will compare symptom changes to see if Galeo offers real relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dihydroxydibutylether (Galeo®), taken as a capsule before meals
- What this could lead to
- If it works, this could offer a new option for people with post-meal stomach discomfort, improving their daily quality of life.
- What could go wrong
- This is a phase 4 trial, but results may not apply to everyone. The treatment may not outperform placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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226 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Jul 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * postprandial distress syndrome according to Rome III criteria * Those who have at least 3 of the 10 symptoms of the GIS evaluation are moderate or more and have at least 1 of bloating, delayed digestion, belching, and nausea * Those with no organic lesions on the upper gastrointestinal endoscopy within 3 months prior to screening Exclusion Criteria: * Those who have confirmed the following medical history or surgical history at the time of screening 1. Surgery that may affect gastrointestinal motility (eg, laparoscopic or laparotomy of the gastrointestinal tract) (except for appendectomy and hysterectomy due to simple appendicitis) 2. Diseases that can cause organic dyspepsia, such as irritable bowel syndrome, inflammatory bowel disease, gastroesophageal disease, and duodenal disease (gastric ulcer, esophagitis \[from RE A\], etc.) within 3 months before screening history of drug use 3. Malignant tumors of the digestive system (except in cases where there is no history of recurrence within 5 years or cases where a cure has been obtained) 4. Other malignant tumors other than the digestive system within 5 years (however, except for if there is no history of recurrence within 5 years or cured cases) 5. History of organic neurological or psychiatric disorders (major depressive disorder or anxiety disorder, etc.), alcoholism, substance abuse, and drug dependence (except nicotine and caffeine) * Those with the following diseases at the time of screening 1. Organic causes of gastroparesis (diabetic gastroparesis, etc.) 2. glaucoma 3. urinary tract disease or prostate disease 4. Biliary duct obstruction or biliary duct stones (eg, intrahepatic gallstones, extrahepatic gallstones) 5. uncontrolled diabetes mellitus (glycated hemoglobin \> 8.0%) 6. Aspartate transaminase or alanine aminotransferase levels are more than 3 times the upper limit of normal, or total bilirubin levels are more than 3 times the upper limit of normal, or liver disease 7. Serum creatinine level is 1.5 times or more of the upper limit of normal, or renal disease 8. Other clinically significant diseases of the heart (blood pressure 160/100 mmHg or more), kidney, lung, blood, and endocrine system, and dysfunction that may affect efficacy and safety evaluation * Those who have administered the following drugs that may affect efficacy evaluation within 2 weeks before screening 1. emollient: artichoke extract, ursodeoxycholic acid, etc. 2. prokinetics: metoclopramide, itopride, etc. 3. inhibitors of gastric acid secretion: H2 receptor antagonist (proton pump inhibitor), gastric acid pump antagonist (acid pump antagonist) 4. gastric mucosal protective agent, antacid, digestive agent 5. fundus relaxants: sumatriptan, buspirone, etc. 6. cholinergic, anticholinergic and antispasmodic 7. psychotropic drugs: antipsychotic drugs, antidepressants, antimanic drugs, antianxiety drugs, hallucinogens, etc. 8. Nonsteroidal anti-inflammatory drugs (intermittent administration up to 1 week 2 days and cyclooxygenase-2 selective inhibitors are acceptable) 9. Antithrombotic agents (antiplatelet agents, anticoagulants) 10. systemic glucocorticoids 11. Erythromycin (However, in the case of eye drops, the administration is allowed) If the above drugs are administered, registration is possible after a wash-out period of at least 2 weeks, and drugs used for the purpose of pretreatment for upper gastrointestinal endoscopy (midazolam, propofol, simethicone), hyoscine butylbromide, cimetropium bromide, etc.) are allowed within 1 day. * Those who received Helicobacter pylori eradication treatment within 2 weeks before screening * Those who have administered or treated other clinical trial drugs or medical devices within 3 months prior to screening * Pregnant or lactating women * Women or men of childbearing potential who are unwilling to use an appropriate method of contraception\* during this clinical trial \*hormonal contraceptives, implantation of intrauterine devices or intrauterine systems, vasectomy, tubal ligation, double-blocking contraception (using a cervical cap or diaphragm and a male condom simultaneously), etc. * If there are other diseases that may affect this clinical trial * Persons with hypersensitivity or allergy to clinical investigational drugs and similar drugs or to soybean oil, soybean, peanut * Persons judged unsuitable to participate in clinical trials by investigators
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chungnam National University Hospital
Daejeon, South Korea
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Dong-A University Hospital
Busan, South Korea
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Hallym University Sacred Heart Hospital
Anyang, South Korea
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Korea University Guro Hospital
Seoul, South Korea
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Koreal University Anam Hospital
Seoul, South Korea
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Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612, South Korea
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