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Safety and tolerability study of sodium hydrogen carbonate and sodium dihydrogen phosphate suppository treatment in adult patients with chronic constipation

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study examines the effects of Lecicarbon® E CO2-Laxans in people with chronic constipation. Chronic constipation is a condition where a person has two or fewer bowel movements per week, along with symptoms such as hard stools, incomplete evacuation feelings, or straining during bowel movements that persist for at least 6 months.

The purpose of this study is to evaluate how safe and well-tolerated Lecicarbon® E CO2-Laxans is when used as a long-term treatment. The medication is given as a suppository for rectal use and contains two active ingredients: sodium hydrogen carbonate and sodium dihydrogen phosphate. Patients may receive up to two units daily for a treatment period of up to 4 weeks.

During the study, participants will need to keep a diary to track their bowel movements and symptoms. The study will also look at how the treatment affects constipation symptoms and overall quality of life. The medication works by producing carbon dioxide, which helps stimulate bowel movements.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your participation begins with confirming that you meet the eligibility criteria, including being 18 years or older and having chronic constipation (two or fewer bowel movements per week) for at least 6 months
If you are a woman of childbearing age, you will need to take a pregnancy test, which must be negative to participate
You will need to stop any current constipation treatments you may be using
Step 2
Treatment period
You will receive Lecicarbon® E CO2-Laxans in the form of suppositories for rectal use
During the study period, you will need to maintain your current lifestyle and dietary habits without changes
You will be required to maintain a patient diary to record your bowel movements and symptoms
Step 3
Monitoring and assessment
Your progress will be tracked using a measure called complete spontaneous bowel movements (CSBM)
You will complete questionnaires about your constipation symptoms using a tool called PAC-SYM
Your quality of life will be evaluated using a questionnaire called PAC-QOL
Step 4
Study duration
The study is scheduled to run from August 2025 to August 2026
Your participation will help evaluate the safety and tolerability of long-term treatment with Lecicarbon® for chronic constipation

Who can join the trial?

8 criteria

Must be 18 years or older, can be male or female
Must be able to move independently or use a wheelchair. If paralyzed, only patients with paraplegia (paralysis of the lower body) can participate
Must have chronic constipation for at least 6 months, defined as: - Having two or fewer bowel movements per week - Having very hard stools at least 25% of the time - Feeling incomplete evacuation after at least 25% of the time - Straining during bowel movements at least 25% of the time
Must provide written consent for participation and sharing of personal data in anonymous form
Women who can become pregnant must have a negative pregnancy test at the first visit
Must stop any current constipation treatments before starting the study
Must agree not to change lifestyle and eating habits during the study period
Must be willing to maintain a patient diary according to study requirements

Who cannot join the trial?

14 criteria

Age below 18 years or above 65 years
Pregnancy or breastfeeding
History of inflammatory bowel disease (conditions causing inflammation in the intestines)
Current or recent use of medications that affect bowel movements
Known allergy or sensitivity to any components of Lecicarbon®
Severe liver or kidney disease
Active gastrointestinal bleeding
Recent abdominal surgery (within the last 3 months)
Current participation in other clinical trials
Inability to follow study procedures or provide informed consent
Severe mental health conditions that could affect compliance
History of colorectal cancer (cancer of the large intestine or rectum)
Uncontrolled high blood pressure or heart disease
Major medical conditions that could interfere with study participation

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Verified sites

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Klinikum Bayreuth GmbH
Verified
Bayreuth, Germany
Studienzentrum Bocholderstrasse
Verified
Essen, Germany

Trial locations

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Investigated drugs

Lecicarbon is a medication used to treat chronic constipation. It works as a suppository that helps stimulate bowel movements in a natural way. The medication contains carbon dioxide-releasing ingredients that create gentle pressure in the rectum, which helps trigger the urge to have a bowel movement. This mechanical action is combined with a mild lubricating effect that makes it easier to pass stools.

What is already known about the treatment

Lecicarbon - A medication administered in suppository form used for the treatment of chronic constipation. This laxative works by releasing carbon dioxide when it comes into contact with intestinal moisture, which creates a gentle mechanical stimulus to promote bowel movement. The medication belongs to the class of stimulant laxatives and works locally in the rectum, making it particularly suitable for patients who need regular, predictable relief from constipation. Lecicarbon has been well-documented in medical literature as a safe option for long-term management of chronic constipation, with its mechanism of action being primarily physical rather than chemical.

Investigated diseases

Chronic Constipation - A persistent condition where bowel movements occur less frequently than normal, typically fewer than three times per week. It is characterized by hard, dry stools that are difficult to pass and often accompanied by straining during bowel movements. People with this condition may experience bloating, abdominal discomfort, and a sensation of incomplete evacuation. The condition can develop due to various factors including dietary habits, lifestyle, or underlying health issues. Chronic constipation differs from occasional constipation as it persists for several weeks or longer.