Amara-Tropfen vs. placebo for irritable bowel syndrome (IBS)

Ki vehet részt

• Patients (all genders/sexes) ≥ 18 to ≤ 75 years at inclusion
• Patients with diagnostic criteria of Irritable Bowel Syndrome (German IBS guideline, 2021) and - for patients younger than 50 years at screening a normal colonoscopy not older than 5 years or stool Calprotectin value of <100 mg/kg not older than 8 weeks at screening - for patients with an age of 50 years or older at screening a normal colonoscopy not older than 5 years is mandatory. Definition according to German guideline: The disease of irritable bowel syndrome (RDS; Irritable Bowel Syndrome/IBS) is present if all 3 points (a-c) are fulfilled. a. There are chronic, i.e. lasting longer than 3 months or recurrent complaints (e.g. abdominal pain, flatulence), which the patient and doctor relate to the bowel and are usually accompanied by changes in bowel movements. b. the complaints should justify the patient seeking help and/or worrying about them and be severe enough to have a relevant impact on quality of life. c. the prerequisite is that there are no changes characteristic of other clinical pictures that are probably responsible for these symptoms
• Mean discomfort intensity of ≥ 40 mm on a Visual Analogue Scale (VAS) (out of 100 mm) over 7 days – assessed before baseline (visit 2)
• Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) ≥ 175 at inclusion and baseline
• Body mass index (BMI) ≤ 40 at inclusion
• Patients willing and able to follow the trial assessments and trial procedure for the entire trial duration
• Female patients of childbearing potential using highly efficient contraceptive methods from screening throughout the study until visit 5
• Signed informed consent prior to any trial related procedure

Ki nem vehet részt

• Administration of any drug containing active ingredients of Amara-Tropfen (currently or within 28 days prior to baseline (visit 2))
• Concurrent participation in another clinical study or administration of an IMP in another clinical trial within 3 months prior to screening visit or within five half-lives, whichever is longer
• Administration of not permitted therapy (for details see sections “prior and concomitant therapy”)
• Change in relevant medical treatment during the last 28 days prior to baseline (visit 2) (e.g., proton pump inhibitor, antidepressants) or planned for the duration of the study
• Change of any drug or dose for IBS during the last 28 days prior to baseline (visit 2)
• Clinically relevant psychiatric comorbidity (Hospital Anxiety and Depression Scale [HADS] score ≥14 each
• Known hypersensitivity against / intolerability to Cichorium, other Asteraceae or constituents of the IMP
• Any condition that interferes with the participation in the clinical study at the discretion of the investigator (e.g. known drug, alcohol abuse, presence of severe diarrhea defined as watery or loose stool more than three times daily or severe constipation defined as hard stool less than three times a week)
• Participants, who are inmates of psychiatric wards, prison or state institutions
• History of major abdominal surgery (appendectomy, hysterectomy, cholecystectomy, hernia repair are not exclusion criteria) within the last 5 years
• Known active severe infection diseases
• Known diabetes mellitus type I and/or type II
• Known existing relevant somatic condition (e.g. severe impaired renal function, severe liver disease, severe pulmonary disease, severe long/post COVID)
• History of or known existing malignancy during the past 5 years before screening visit except for history of basal cell carcinoma and melanoma in situ
• Positive urine pregnancy test (applicable for female participants of childbearing potential) or lactation
• Patients who are staff of the study sites, staff of the CRO or the sponsor company or a member of the trial team