Study on the Effectiveness and Safety of Betaine Citrate for Treating Functional Dyspepsia in Adults

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What is this study about?

This clinical trial is focused on studying the condition known as Functional Dyspepsia, which is a type of indigestion that causes discomfort or pain in the upper abdomen. The trial will evaluate the effectiveness and safety of a treatment called ALKACITRAT, which contains the active substance Betaine Citrate. Participants in the study will receive either the ALKACITRAT treatment or a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to assess how well ALKACITRAT works in relieving symptoms of functional dyspepsia and to ensure it is safe for use. Participants will take the treatment orally, meaning it is swallowed, over a period of time. Throughout the study, researchers will monitor the participants to see if there is an improvement in their symptoms and to check for any side effects.

The study will compare the results between those taking ALKACITRAT and those taking the placebo to determine the treatment’s effectiveness. Researchers will look at changes in the severity of symptoms and overall quality of life. The study will also track any adverse events, which are unexpected medical problems that may occur during the trial. The findings will help in understanding whether ALKACITRAT is a beneficial treatment option for people with functional dyspepsia.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be between 18 and 75 years old, meet the Rome IV criteria for functional dyspepsia, and have a GOS score of 4 or higher. Participants must also be legally competent and able to understand the study information, voluntarily agree to participate, and sign the informed consent form.

2 baseline visit (V0)

During the baseline visit, initial assessments are conducted. These assessments include evaluating symptoms and quality of life using specific scales such as the GOS score and NDI-SF index. This visit establishes a reference point for future comparisons.

3 treatment phase

Participants receive the investigational medicinal product, ALKACITRAT, in the form of an oral solution. The dosage is 2 grams per tablet, taken as directed. The treatment aims to evaluate the effectiveness and safety of ALKACITRAT in treating functional dyspepsia.

4 end of treatment visit (V1)

At the end of the treatment phase, a follow-up visit is conducted. The primary endpoint is the comparison of the percentage of patients with improvement in symptoms, measured by a change in the GOS score. Secondary endpoints include changes in quality of life, symptom severity, and the frequency and type of any adverse events.

Who Can Join the Study?

Men and women who are between 18 and 75 years old.
Patients who have symptoms of functional dyspepsia. This is a type of indigestion that doesn’t have a clear cause.
Patients who meet the Rome IV criteria for functional dyspepsia. These are specific guidelines doctors use to diagnose this condition.
Patients with a GOS score of 4 or higher. This is a way to measure the severity of symptoms.
Patients who are legally able to make decisions and understand the study details.
Patients who have been informed about the study, understand its purpose, and agree to participate by signing a consent form.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergies to medications are excluded.
People currently participating in another clinical trial are not eligible.
Patients with serious heart conditions, such as heart failure, are excluded.
Individuals with liver or kidney disease cannot take part.
People with a history of alcohol or drug abuse are not eligible.
Patients with mental health disorders that are not well-controlled are excluded.
Individuals who have had stomach surgery in the past are not eligible.
People who are unable to follow the study procedures or instructions cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece

Trial status

Country	Status	Recruitment Start
Greece	Recruiting	01.05.2024

Trial locations

Investigated drugs:

Betaine Citrate

ALKACITRAT is being studied for its effectiveness and safety in treating functional dyspepsia. Functional dyspepsia is a common digestive disorder that causes discomfort or pain in the upper abdomen. The trial aims to determine how well ALKACITRAT works in relieving the symptoms associated with this condition and to ensure that it is safe for patients to use.

Functional Dyspepsia – Functional dyspepsia is a common digestive disorder characterized by persistent or recurring pain or discomfort in the upper abdomen. It is not caused by any identifiable structural or biochemical abnormalities. Symptoms often include bloating, nausea, and a feeling of fullness after eating only a small amount of food. The condition can be triggered by stress, diet, or other lifestyle factors. It tends to be chronic, with symptoms that can fluctuate in intensity over time. The exact cause of functional dyspepsia is not well understood, but it is believed to involve a combination of factors, including abnormal motility and heightened sensitivity of the stomach.

Trial ID:

2024-512688-30-00

Protocol code:

UNI-BETAIN

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Betaine Citrate for Treating Functional Dyspepsia in Adults

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