2024-514892-16-00招募中4 期
Controlled clinical trial to investigate the efficacy and safety of MYRRHINIL-INTEST® versus placebo in patients with diarrhoea-dominant irritable bowel syndrome (IBS-D) and patients with mixed-type irritable bowel syndrome (IBS-M)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 9
- 主要终点
- Efficacy is assessed by a responder criterion, which is specified differently for patients with IBS-D and IBS-M. For both subgroups, a response of the abdominal pain is required (NRS pain): IBS-D patients: additional assessment of stool consistency stool consistency (Bristol Stool Form Scale). IBS-M patients: additionally an overall assessment of the change in bowel health using the PGI-I scale is also required.
研究概览
简要总结
Proof of efficacy, safety and tolerability of MYRRHINIL-INTEST® versus placebo in the treatment of diarrhoea-dominant irritable bowel syndrome irritable bowel syndrome (IBS-D), as well as irritable bowel syndrome of the mixed type (IBS-M)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Since the onset of the disease the following have not been present: - Weight loss within the past 6 months; - nocturnal symptoms (e.g. abdominal pain, diarrhoea); - History of 1st degree relatives with colon carcinoma
- •Assessment of IBS-D or IBS-M symptoms: - NRS Pain > 3 points on Visit 1 and Visit 2; the value of the NRS Pain on Visit 2 differs from that on Visit 1 by a maximum of 1 point; - IBS-SSS > 75 points on Visit 1 and Visit 2; the value of the IBS-SSS on Visit 2 differs from that on Visit 1 by a maximum of 25 points; - Stool consistency documented by the patient using the Bristol Stool Shape Scale. Assessment according to Rome IV criteria: Diarrhoea-dominant IBS (IBS-D): If > 25% of bowel movements according to Bristol Stool Form Scale type 6-7 and < 25% of bowel movements according to Bristol Stool Form Scale type 1-2 Mixed type IBS (IBS-M): If > 25% of bowel movements according to Bristol stool form scale type 1-2 and > 25% of bowel movements according to Bristol stool form scale type 6-7; - Stool frequency > 3 bowel movements/day or < 3 bowel movements/week
- •Presence of a signed informed consent form from the patient
- •Agreement to avoid changes in lifestyle and dietary habits during the study duration
- •Exclusion of chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease, microscopic colitis, bile acid leakage syndrome): Colon examination (colonoscopy) performed within the last 5 years in patients > 55 years before participation in the study
- •Willingness to diligently keep a patient diary
- •Negative pregnancy test for individuals of childbearing potential
- •Stool samples on inclusion in the study (result available at visit 2): Exclusion of blood in the stool, except: - Traces of blood due to local irritation and/or an anal fissure due to frequent defecation or hard stool consistency (determined by local inspection or a digital rectal examination); - Traces of blood due to haemorrhoids (determined by a digital rectal examination or proctoscopy); Exclusion of clinically relevant elevated calprotectin levels (> 50 µg/g) in the faeces; Exclusion of a Clostridioides (formerly Clostridium) difficile infection using glutamate dehydrogenase (GDH) ELISA; Exclusion of yersiniosis
- •Patients of both sexes aged ≥ 18 and ≤ 75 years
- •IBS-D or IBS-M diagnosis confirmed according to Rome IV criteria: Recurrent abdominal pain over the last three months (six months prior to diagnosis) averaging at least one day per week, associated with at least one of the following factors: - Associated with defecation; - Associated with a change in stool frequency; - Associated with a change in stool consistency
排除标准
- •Confirmed diagnosis of microscopic colitis, ulcerative colitis, or Crohn's disease
- •Immunocompromised patients (patients with organ transplantation within the past 3 years, patients with known HIV infection, etc.)
- •Confirmed diagnosis of IBS subtype constipation (IBS-C) or undefined IBS (IBS-U) according to Rome IV criteria
- •History of colon resection
- •Known diabetes mellitus, type I and/or type II
- •Inadequate medication control for known hyperthyroidism or hypothyroidism, Hashimoto's thyroiditis, or signs of thyroid dysfunction according to blood values from visit 1 and at the discretion of the investigator
- •Known hypersensitivity to myrrh, chamomile flowers, or any excipients of MYRRHINIL-INTEST® or placeboKnown hypersensitivity to myrrh, chamomile flowers, or any excipients of MYRRHINIL-INTEST® or placebo
- •Diagnosed severe somatic/psychosomatic, neurological, and/or psychiatric disorders making it difficult for the patient to make an informed decision about participation in the clinical trial. Assessment at the discretion of the treating investigator
- •Use of neuroleptics up to 1 month before study start and during study participation
- •Use of antibiotics within the last 10 days before study start and/or during study participation
- •Use of systemic corticosteroids up to 1 month before study start and during study participation
- •Liver or kidney dysfunction (serum creatinine, serum AST or ALT at least 3 times the upper reference value in the last 12 months prior to inclusion in the study)
- •Use of medication to treat IBS-D or IBS-M (including herbal and probiotic medicines) at visit 1 and during study participation (except for study medication and emergency medication)
- •Ongoing use of NSAIDs (non-steroidal anti-inflammatory drugs, e.g., ibuprofen) for more than 14 days (except NSAIDs used as medication for thrombosis prevention in low doses, e.g., aspirin, or for treating adverse events)
- •Suspected acute appendicitis
- •Use of iron supplements and cardiac glycosides
- •Use of opioids (e.g., morphine, tilidine, tramadol, etc.) up to 1 month before study start and during study participation
- •Patients who participated or are participating in other drug studies within 30 days prior to initial screening or during the clinical trial, or who previously participated in the same study (randomization)
- •Patients with a disease or in a situation that, in the opinion of the investigator, poses a significant risk to the patient, may affect study results, or significantly influence these results
- •Signs or symptoms of an emerging bacterial or viral infection accompanied by fever (> 38.5 °C)
- •Abnormal laboratory values (clinically significant, i.e., more than three times the upper or lower limit of the laboratory's reference range or significant at the discretion of the investigator)
- •Deviating forms of food intake: - Need for artificial nutrition; - Use of formula diets; - parenteral nutrition
- •Patients with known or suspected cholangitis, gallstones, bile acid loss syndrome, biliary obstruction or other gallbladder diseases, sphincter of Oddi dysfunction or abdominal adhesions
- •Existing alcohol abuse or medication/drug abuse
- •If stool tests were performed in the 6 months prior to inclusion in the study: Positive test for blood in the stool, except: - Traces of blood due to localised irritation and/or anal fissure due to frequent defecation or hard stool consistency (detected by local inspection or digital rectal examination); - Traces of blood due to haemorrhoids (determined by digital rectal examination or rectoscopy); Positive test for parasites and worm eggs ; Clinically relevant elevated calprotectin levels (> 50 µg/g) in the stool
- •Pregnant, breastfeeding mothers, or individuals of childbearing potential refusing to use a reliable method of contraception (Pearl Index < 1)
- •Legal incapacity and/or other circumstances preventing the patient from understanding the nature, purpose, and consequences of the study
- •Individuals institutionalized by order of authorities or courts
- •Uncooperative patients
- •Patients with insufficient knowledge of the German language (informed consent)
- •Patients in a dependency relationship with the sponsor, investigator, other study personnel, or the study site
- •Diagnosed infectious gastroenteritis
- •Known abnormalities of the gastrointestinal tract (e.g., megacolon) or known diseases leading to altered gastrointestinal transit (e.g., colon polyps)
- •Past or suspected pancreatitis, ileus or gastrointestinal bleeding
- •Female patients with known endometriosis
- •Patients with gastroesophageal reflux disease (GERD)
- •Known or suspected other causes of diarrhea: celiac disease; fructose, lactose, sorbitol intolerance, or other intolerances leading to diarrhea symptoms
- •Patients with malignant diseases or cancer treatments of the gastrointestinal tract in the last 5 years, as well as in any other part of the body in the last 2 years before inclusion in the study, with ongoing risk potential
- •Known autoimmune diseases affecting the gastrointestinal tract
结局指标
主要结局
Efficacy is assessed by a responder criterion, which is specified differently for patients with IBS-D and IBS-M. For both subgroups, a response of the abdominal pain is required (NRS pain): IBS-D patients: additional assessment of stool consistency stool consistency (Bristol Stool Form Scale). IBS-M patients: additionally an overall assessment of the change in bowel health using the PGI-I scale is also required.
Efficacy is assessed by a responder criterion, which is specified differently for patients with IBS-D and IBS-M. For both subgroups, a response of the abdominal pain is required (NRS pain): IBS-D patients: additional assessment of stool consistency stool consistency (Bristol Stool Form Scale). IBS-M patients: additionally an overall assessment of the change in bowel health using the PGI-I scale is also required.
次要结局
- Abdominal pain (NRS pain, measured using an 11-point numerical rating scale, pain intensity 0 – 10), daily entry in the patient diary, assessed during visits 1-5 at the study center
- Number of spontaneous bowel movements, daily entries by the patient in the patient diary
- Stool consistency on individual days measured using the Bristol Stool Form Scale, daily entry in the patient diary, assessed during visits 1-5 at the study center
- Frequency of the feeling of incomplete bowel evacuation, daily entries by the patient in the patient diary
- Occurrence of mucus and/or blood in the stool on individual days, daily entry in the patient diary, assessed during visits 1-5 at the study center
- Assessment of the severity of IBS-D or IBS-M symptoms using the IBS-Severity Scoring System (IBS-SSS) during visits 1-5 (visit assessment: completed by the patient)
- Determination of quality of life (Quality of Life) using the IBS-QoL questionnaire during visits 1-5 (visit assessment: completed by the patient)
- Overall assessment of changes in gut health using a 7-point scale (Patient Global Impression of Improvement Scale – PGI-I), assessed at visit 4 at the study center
- Global assessment of efficacy by the investigator and the patient during visits 3 and 4 (4-point scale)
- Reduced use of loperamide, Buscopan®, and mebeverine as emergency medication for the treatment of IBS-D or IBS-M symptoms (visits 1 to 5)
- Compliance (amount of study medication consumed) during on-site visits 3 and 4 via drug accountability
- Adverse events (AEs) throughout the study (V2-V5)
- Vital signs (blood pressure, pulse, body temperature) at V1-V5
- Clinical chemistry and hematology at V1, V3, and V4
- Assessment of tolerability by the investigator and the patient during visits 3 and 4
研究者
Repha GmbH
Scientific
REPHA GmbH Biologische Arzneimittel
研究点 (9)
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