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Clinical study to evaluate the safety and tolerability of long-term treatment with Lecicarbon® in patients with chronic constipation
EU CTIS ID: 2025-522464-32-00
What this study is testing
Clinical study to evaluate the safety and tolerability of long-term treatment with Lecicarbon® in patients with chronic constipation
- 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 of both sexes aged 18 years and older
- Reliable contraception during participation in the clinical trial
- Patients with and without limited walking ability/mobility (at least wheelchair mobility); in the case of paraplegia, however, only paraplegic patients
- Patients with a diagnosis of chronic constipation defined as two or fewer bowel movements per week (bowel movements not preceded within 24 hours by the use of laxatives or enemas leading to a feeling of complete evacuation) and at least one or more of the following symptoms over a period of at least 6 months: very hard or hard stools at least 25% of the time; feeling of incomplete evacuation after at least 25% of the stools; straining to defecate at least 25% of the time
- Signed consent to participation and to the collection and pseudonymised forwarding of personal data
- Negative pregnancy test for women of childbearing potential at visit 1
You likely can't join if
- Uncooperative patients
- Taking medication for constipation during the clinical trial (except emergency medication Glycilax®)
- Pregnant patients
- Patients who have undergone relevant operations in the gastrointestinal tract (surgical procedures affecting the intestine, such as intestinal resection, rectopexy, hernia operations and pelvic floor surgery, or intestinal surgery such as partial removal of the intestine and STARR surgery (stapled transanal rectal resection)).
- Known hypersensitivity to soy, peanuts or any of the other ingredients of Lecicarbon® E CO2 laxative.
- Patients with secondary constipation (endocrine and metabolic diseases, medications (including opioids))
See the full eligibility criteria
Who can join
- Patients of both sexes aged 18 years and older
- Reliable contraception during participation in the clinical trial
- Patients with and without limited walking ability/mobility (at least wheelchair mobility); in the case of paraplegia, however, only paraplegic patients
- Patients with a diagnosis of chronic constipation defined as two or fewer bowel movements per week (bowel movements not preceded within 24 hours by the use of laxatives or enemas leading to a feeling of complete evacuation) and at least one or more of the following symptoms over a period of at least 6 months: very hard or hard stools at least 25% of the time; feeling of incomplete evacuation after at least 25% of the stools; straining to defecate at least 25% of the time
- Signed consent to participation and to the collection and pseudonymised forwarding of personal data
- Negative pregnancy test for women of childbearing potential at visit 1
- Discontinuation of previous therapy for constipation (if applicable)
- Agreement to avoid changes in lifestyle and dietary habits during the study period
- Willingness to keep a patient diary in accordance with regulations
- Patients whose symptoms of chronic constipation could not be sufficiently improved by conservative treatment (such as fluid intake, exercise, high-fibre diet)
What rules you out
- Uncooperative patients
- Taking medication for constipation during the clinical trial (except emergency medication Glycilax®)
- Pregnant patients
- Patients who have undergone relevant operations in the gastrointestinal tract (surgical procedures affecting the intestine, such as intestinal resection, rectopexy, hernia operations and pelvic floor surgery, or intestinal surgery such as partial removal of the intestine and STARR surgery (stapled transanal rectal resection)).
- Known hypersensitivity to soy, peanuts or any of the other ingredients of Lecicarbon® E CO2 laxative.
- Patients with secondary constipation (endocrine and metabolic diseases, medications (including opioids))
- Patients with tetraplegic paraplegia
- Any physical or mental limitations that significantly restrict the performance of the study procedures
- Patients with ileus (intestinal obstruction) or megacolon
- Clinically significant (as assessed by the investigator) history of cancer as well as cardiovascular, liver, lung, endocrine, neurological or psychiatric diseases or metabolic disorders
- Patients unable to give informed consent
- Patients who do not have sufficient command of the German language (informed consent form)
- Patients who are dependent on the sponsor, investigator, other study personnel or the study centre
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, 65+ years, 18-64 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.