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Betaine Citrate

This article discusses a clinical trial investigating the effectiveness and safety of Betaine Citrate, marketed as ALKACITRAT®, in treating functional dyspepsia in adults. Functional dyspepsia is a common digestive disorder that causes discomfort in the upper abdomen. The study aims to assess how well this medication works and its safety profile when used to alleviate symptoms associated with this condition.

Table of Contents

What is Betaine Citrate?

Betaine Citrate is a chemical compound that is being studied as a potential treatment for digestive issues. It is the active ingredient in a medication called ALKACITRAT®, which is available as an oral solution[1]. Betaine Citrate belongs to a class of substances known as betaines, which are naturally occurring compounds found in various foods and in the human body.

Understanding Functional Dyspepsia

Functional dyspepsia is a common digestive disorder that causes discomfort in the upper abdomen. Symptoms may include pain, burning sensation, fullness, or bloating after meals. Unlike some other digestive issues, functional dyspepsia doesn’t have a clear physical cause that can be seen during medical tests[1]. This condition can significantly affect a person’s quality of life and eating habits.

Clinical Trial on Betaine Citrate for Functional Dyspepsia

A clinical trial is currently being conducted to evaluate the effectiveness and safety of ALKACITRAT® (which contains Betaine Citrate) for treating functional dyspepsia in adults[1]. This study aims to determine whether Betaine Citrate can help alleviate the symptoms of functional dyspepsia and improve patients’ quality of life.

Who Can Participate in the Study?

The study is looking for participants who meet specific criteria. Here are the main inclusion criteria:

  • Adults aged 18-75 years old
  • Patients who meet the Rome IV criteria for functional dyspepsia (a set of diagnostic criteria used by doctors to identify this condition)
  • Patients with a GOS score (Global Overall Symptom scale) of 4 or higher, indicating significant symptoms
  • Individuals who can understand the study information and voluntarily agree to participate

However, some people cannot participate in the study. Exclusion criteria include:

  • Pregnant or breastfeeding women
  • People with symptoms of irritable bowel syndrome or gastroesophageal reflux disease
  • Those with signs of severe disease (such as weight loss, black stools, or difficulty swallowing)
  • Individuals who have had abdominal surgery
  • People with uncontrolled diabetes
  • Those with chronic diarrhea or constipation
  • Individuals with active psychiatric conditions
  • People taking certain medications (like immunosuppressants, antibiotics, or antacids) or probiotics
  • Those with active H. pylori infection (a type of bacteria that can cause stomach problems)

Treatment Details

The treatment period in this study lasts for 7 days[1]. Participants will receive ALKACITRAT®, which contains Betaine Citrate, as an oral solution. The maximum daily dose is 6 grams, and the total dose over the treatment period is 42 grams[1].

Study Objectives and Measurements

The main goal of this study is to compare the percentage of patients who show improvement in their symptoms between the treatment group (those receiving Betaine Citrate) and the control group. Improvement is measured using the GOS scale, which assesses overall digestive symptoms[1].

Other objectives of the study include:

  • Comparing the number of patients who respond well to the treatment
  • Assessing changes in patients’ quality of life using the NDI-SF index (a questionnaire that measures the impact of digestive symptoms on daily life)
  • Evaluating changes in the severity of individual symptoms using a VAS scale (Visual Analog Scale, which measures the intensity of symptoms)
  • Monitoring the frequency and types of any side effects during the study

Potential Benefits and Considerations

If successful, this study could provide evidence for a new treatment option for people suffering from functional dyspepsia. Betaine Citrate might help alleviate symptoms and improve the quality of life for those affected by this condition[1].

However, it’s important to note that as with any medical treatment, there may be potential risks or side effects. The study will carefully monitor participants for any adverse events to ensure their safety.

If you’re interested in learning more about this study or think you might be eligible to participate, it’s best to discuss it with your healthcare provider. They can provide more information and help determine if this treatment option might be suitable for you.

Aspect Details
Study Drug Betaine Citrate (ALKACITRAT®)
Condition Functional Dyspepsia
Study Design Randomized, controlled trial
Treatment Duration 7 days
Monitoring Period 8-9 days
Primary Outcome Improvement in GOS score
Secondary Outcomes Treatment response, quality of life changes, symptom severity changes, adverse events
Dosage Maximum daily dose: 6g, Maximum total dose: 42g
Administration Route Oral

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the effectiveness and safety of ALKACITRAT® (Betaine Citrate) in treating functional dyspepsia in adults.
  • Who can participate in this study? Participants must be men or women aged 18-75 years old, meet the Rome IV criteria for functional dyspepsia, have a GOS score of 4 or higher, and be able to understand and consent to the study.
  • How long does the treatment period last? The treatment period lasts for 7 days, with a monitoring period of 8 to 9 days.
  • What is the primary outcome being measured? The primary outcome is the comparison of the percentage of patients showing improvement (change in GOS score of 2 or more) at the end of treatment compared to the baseline visit between the two treatment groups.
  • Are there any exclusion criteria for the study? Yes, there are several exclusion criteria, including pregnancy, lactation, symptoms of irritable bowel syndrome or gastroesophageal reflux disease, recent abdominal surgery, unregulated diabetes, and active H. pylori infection, among others.

Ongoing Clinical Trials on Betaine Citrate

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

    Recruiting

    1 1 1
    Investigated drugs:
    Greece

Glossary

  • Functional Dyspepsia: A digestive disorder that causes discomfort or pain in the upper abdomen, often accompanied by feelings of fullness, bloating, or nausea.
  • Rome IV criteria: A set of diagnostic criteria used to identify and classify functional gastrointestinal disorders, including functional dyspepsia.
  • GOS score: Global Overall Symptom score, a measure used to assess the severity of dyspepsia symptoms.
  • NDI-SF index: Nepean Dyspepsia Index – Short Form, a questionnaire used to evaluate quality of life in patients with dyspepsia.
  • VAS scale: Visual Analog Scale, a measurement tool used to assess the severity of symptoms on a continuous scale.
  • Proton pump inhibitors: A class of medications that reduce stomach acid production.
  • Prokinetic agents: Medications that enhance gastrointestinal motility and help move food through the digestive system.
  • Histamine receptor antagonists: Medications that block histamine receptors in the stomach, reducing acid production.
  • H. pylori infection: An infection caused by the Helicobacter pylori bacteria, which can lead to stomach ulcers and other digestive issues.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-betaine-citrate-for-treating-functional-dyspepsia-in-adults/