Controlled clinical trial to investigate the efficacy and safety of MYRRHINIL-INTEST® versus placebo in patients with diarrhoea-dominant irritable bowel syndrome (IBS-D)

Ki vehet részt

• Patients of both sexes aged ≥ 18 and ≤ 75 years
• Negative pregnancy test for persons of childbearing potential
• Confirmed IBS-D diagnosis at visit 1
• Colon examination (colonoscopy) performed on patients > 55 years of age within the past 5 years prior to participation in the study
• Stool frequency: Before visit 1 (screening) in the last 7 days on at least 3 days 1 watery bowel movement/day
• Assessment of IBS-D symptoms: a) NRS pain > 3 points on visit 1 and visit 2 b) Stool consistency documented by the patient using the Bristol stool form scale on visits 1 and 2
• Stool samples for testing for the absence of blood in the stool (occult blood test) and the absence of a Clostridioides (formerly Clostridium) difficile infection by means of glutamate dehydrogenase (GDH) ELISA upon inclusion in the study (result available at visit 2)
• Presence of a declaration of consent signed by the patient
• Consent that changes in lifestyle and dietary habits during the dietary habits will be avoided for the duration of the study
• Willingness to keep a patient diary in accordance with the protocol

Ki nem vehet részt

• inappropriate medication for known hyper- or hypothyroidism, Hashimoto's thyroiditis or signs of thyroid dysfunction according to the blood values from Visit 1 and at the discretion of the investigator
• Intake of neuroleptics up to 1 month before the start of the study and during participation in the study
• Intake of antibiotics within the last 10 days before the start of the study and/or during study participation
• Intake of systemic corticosteroids up to 1 month before the start of the study and during study participation participation in the study
• Intake of medication for the treatment of IBS-D (including herbal and probiotic medication) at the time of visit 1 and during participation in the study (with the exception of study medication and emergency medication)
• Intake of opioids (e.g. morphine, tilidine, tramadol, etc.) up to 1 month before the start of the study and during participation in the study
• Patients who participated or are participating in other drug trials (screening) 30 days prior to initial enrolment, or have previously participated in the same study (including randomisation)
• Existing alcohol abuse or abuse of medication or drugs
• If faecal tests were performed in the 6 months prior to inclusion in the study were performed: a) Positive test for blood in faeces except: (Impurities due to haemorrhoids documented by a digital rectal examination or proctoscopy/ Traces of blood due to local irritation caused by frequent defecation (detected by local inspection inspection or a digital rectal examination) b) Positive test for parasites and worm eggs c) Clinically relevant elevated calprotectin levels (> 50 μg/g) in the stool
• Confirmed diagnosis of microscopic colitis, ulcerative colitis or Crohn's disease
• past or suspected pancreatitis, ileus or gastrointestinal haemorrhage
• patients with gastroesophageal reflux disease (GERD) greater than or equal to 2b
• known or suspected other causes of diarrhoea: coeliac disease, fructose, lactose, lactose, sorbitol intolerance or other intolerances that lead to diarrhoea symptoms diarrhoea
• patients with malignant diseases or cancer treatments of the gastrointestinal tract in the last the last 5 years, as well as all other areas of the body in the last 2 years before Inclusion in the study with continued risk potential
• known autoimmune diseases in the area of the gastrointestinal tract
• immunocompromised patients (patients with organ transplants, patients with known HIV infection, etc.)
• condition after partial colon resection
• known diabetes mellitus, type I and/or type II
• Hypersensitivity to camomile, other compositae, myrrh, coffee charcoal or any other component of the test medication MYRRHINIL-INTEST® or the placebo
• diagnosed severe somatic/psychosomatic, neurological and/or psychiatric disorders psychiatric disorders that make it difficult for the patient to make an informed decision about consent to participate in the clinical trial. The judgement is at the discretion of the treating investigator
• Continuous intake of NSAIDs (non-steroidal anti-inflammatory drugs, e.g. ibuprofen) for a period of more than 14 days (with the exception of NSAIDs used as medication to prevent thrombosis [e.g. ASA] or for the treatment of adverse events)
• Intake of cardiac glycosides
• present since the onset of the disease a) Weight loss within the past 6 months (clinically significant, at the discretion of the investigator's judgement) b) Nocturnal symptoms (e.g. abdominal pain, diarrhoea) c) History of 1st degree relatives with colon carcinoma
• Patients with a medical condition or in a situation which, in the opinion of the investigator, exposes the patient to a significant risk, interfere with the study results or significantly influence the study results
• Signs or symptoms of an incipient bacterial or viral infection associated with fever (> 38.5 °C)
• known abnormalities of the gastrointestinal tract (e.g. megacolon) or known diseases diseases that result in an altered gastrointestinal passage (e.g. colon polyps)
• patients with known or suspected gallbladder inflammation (cholecystitis), gallstones, bile acid leakage syndrome, obstruction of the bile ducts or other diseases of the gallbladder gallbladder, dysfunction of the sphincter of Oddi or abdominal adhesions
• patients with the rare hereditary fructose/galactose intolerance, glucose/galactose malabsorption or sucrase malabsorption. malabsorption or sucrase-isomaltase insufficiency
• Abnormal laboratory values (clinically significant, i.e. more than threefold deviation of the upper or lower normal limit of the laboratory or significant at the discretion of the investigator)
• functional disorders of the liver or kidneys (serum creatinine, serum AST or ALT at least 3-fold above the specified reference value in the last 12 months before inclusion in the study)
• female patients with known endometriosis
• Confirmed diagnosis of IBS of the constipation subtype (IBS-C), mixed IBS (IBS-M), or undefined IBS (IBS-U) according to Rome IV criteria
• Deviating forms of food intake: a) Need for artificial nutrition b) Use of formula diets c) parenteral nutrition
• Pregnant women, nursing mothers or persons of childbearing potential who are unable to use a reliable method of contraception (Pearl Index < 1)
• Legal incapacity and/or other circumstances that prevent the patient from understanding the nature, aim and effects of the study
• Persons who have been institutionalised on the basis of an official or court order
• Uncooperative patients
• suspicion of acute appendicitis
• Persons incapable of giving consent
• Patients who do not have sufficient command of the German language (informed consent)
• Patients who are dependent on the sponsor, investigator, other study personnel or the trial site
• Diagnosed infectious gastroenteritis