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Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia
EU CTIS ID: 2024-512688-30-00
What this study is testing
Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with symptoms of functional indigestion will be included if all of the following inclusion criteria apply: 1. Women or men aged 18-75 years old. 2. Patients that meet the Rome IV criteria of functional dyspepsia. 3. Patients with a GOS score≥4. 4. Patients who are legally competent and able to understand the information about the study, have been informed of the nature, scope and utility of the study, voluntarily agree to participate and have signed the informed consent form (ICF).
You likely can't join if
- Exclusion criteria Patients will be excluded if any of the following exclusion criteria apply: 1. Pregnant and lactating women 2. Patients with symptoms of irritable bowel syndrome and gastroesophageal reflux disease. 3. Patients with suspected symptoms of severe disease (weight loss, black stools, difficulty in swallowing). 4. Abdominal surgery. 5. Unregulated diabetes. 6. Stool disorders (chronic diarrhea or constipation). 7. Active psychiatric conditions 8. Intake of immunosuppressants, antibiotics, non-steroidal, anti-inflammatory drugs or probiotics in the last 4 weeks 9. Taking oral antacid medications that act as proton pump inhibitors, prokinetic agents, histamine receptor antagonists, and laxatives during the study 10. Patients that daily use aspirin 11. Alcohol use of more than ten units (units) per week 12. Active H. pylori infection 13. Participation in another study of an investigational medicinal product or investigational medical device
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.