A confirmed diagnosis of irritable bowel syndrome (IBS-D or IBS-M) by a specialist in gastroenterology and/or internal medicine and/or general medicine MedDRA version: 20.0 Level: LLT Classification code 10023002 Term: Irritable bowel System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 26.0 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: MYRRHINIL-INTEST®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: myrrh powder
CAS Number: 9000-45-7
Other descriptive name: MYRRH
Concentration unit: mg milligram(s)
Concentration
Sponsors
Repha GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of both sexes aged =18 and = 75 years - IBS-D or IBS-M diagnostic confirmed according to Rome IV criteria - Recurrent abdominal pain in the last three months (six months prior to diagnosis) on average 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 - Evaluation of the IBS-D or IBS-M symptoms: o NRS pain > 3 points at visit 1 and visit 2; the value of NRS pain at visit 2 differs from that at visit 1 by max. 1 point o 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 max. 25 points o stool consistency documented by the patient using the Bristol stool form scale. Evaluation according to Rome IV criteria: Diarrhoe-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 and > 25% of bowel movements according to Bristol stool form scale type 6 - 7 o Stool frequency > 3 bowel movements/day or 55 years before Study Participation - Stool sample analyses (samples from visit 1, results have to be available at visit 2): o Exclusion of blood in stool,except: - Blood traces 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). - Blood traces due to hemorrhoids (detected by digital rectal examination or proctoscopy) o Exclusion of clinically relevant increased calprotectin values (> 50 µg/g) in stool o Exclusion of Clostridium difficile infection by Glutamate Dehydrogenase (GDH) ELISA o Exclusion of yersiniosis - the Patient did not experience the following symptoms since disease onset: o weight loss within the last 6 months o nocturnal symptoms (e.g. abdominal pain, diarrhoea) o Anamnesis with relatives of 1st degree with colon carcinoma - Presence of a declaration of consent signed by the patient - Understanding that changes in lifestyle and eating habits are avoided during the study period - Willingness to keep a regular patient diary - Negative pregnancy test for persons capable of giving birth Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: a) Diseases 1. confirmed diagnosis of microscopic colitis, ulcerative colitis or Crohn'sdisease 2. confirmed diagnosis of constipation subtype IBS (IBS-C) or undefinedIBS (IBS-U) according to Rome IV criteria 3. suspicion of acute appendicitis 4. if stool tests have been performed in the previous 6 months prior to inclusion in the study: o Exclusion of blood in stool,except: - Blood traces 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).- Blood traces due to hemorrhoids (detected by digital rectal examination or proctoscopy) o Positive test for parasites and worm eggs o clinically relevant increased calprotectin values (> 50 µg/g) in stool 5. diagnosed infectious gastroenteritis 6. known anomalies of the gastrointestinal tract (e.g. megacolon) or known diseases resulting in an altered gastrointestinal passage (e.g. colonic polyps) 7. liver or kidney dysfunction8. patients with known or suspected gallbladder inflammation (cholangitis), gallstones, Syndrome of loss of bile acids, obstruction of the bile ducts or other gallbladder diseases, sphincter oddi dysfunction or abdominal adhesions 9. past or suspected pancreatitis, ileus or gastrointestinal bleeding 10. female patients with known endometriosis 11. patients with gastroesophageal reflux disease (GERD) 12. known or suspected other reasons for diarrhoea: celiac disease; fructose, lactose, sorbitol intolerance or other intolerances leading to symptoms of diarrhoea 13. patients with malignant diseases or cancer treatments of the gastrointestinal tract in the last 5 years, as well as all other areas of the body in the last 2 years before inclusion in the study with continuing risk potential 14. known autoimmune diseases in the gastrointestinal tract 15. immunocompromised patients (patients with organ transplantation within the previous 3 years, patients with known HIV infection, etc.) 16. condition after partial colon resections 17. known diabetes mellitus, type I and/or type II 18. Inadequate drug medication for known hyperthyroidism, hypothyroidism, Hashimoto's thyroiditis, or evidence of thyroid dysfunction according to visit 1 blood results and at the investigator's discretion. 19. known hypersensitivity to myrrh, chamomile flowers or any of the adjuvants of MYRRHINIL-INTEST® or placebo 20. Serious somatic/psychosomatic, neurological and/or psychiatric conditions diagnosed and making it difficult for the patient to make an informed decision about consent to participate in the clinical trial. This is assessed by the investigator treating the patient. b) Medication 1. taking neuroleptics up to 1 month before the start of the study and during participation in the study 2. taking antibiotics within the last 10 days before the start of the study and/or during participation in the study 3. taking of systemic corticosteroids up to 1 month before the start of the study and during participation in the study 4. taking medication to treat IBS-D or IBS-M (including herbal and probiotic medicines) at visit 1 and within the last 30 days prior to the start of the study 5. continued use of NSAIDs (non-steroidal anti-inflammatory drugs, e.g. ibuprofen) for more than 14 days (excluding NSAIDs used as low-dose thrombosis prevention medication, e.g. acetylsalicylic acid or to treat adverse events) 6. intake of iron preparations and cardiac glycosides 7. Intake of opioids c) General ana
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstration of efficacy, safety and tolerability of MYRRHINIL-INTEST® versus placebo in the treatment of diarrhea-dominant irritable bowel syndrome (IBS-D) and mixed-type irritable bowel syndrome (IBS-M);Secondary Objective: • abdominal pain • Number of spontaneous bowel movements • Stool consistency • Number of incidences of the feeling of incomplete defecation • Occurrence of mucus and / or blood in the stool • IBS-D or IBS-M symptom severity assessment using the IBS-Severity Scoring System (IBS-SSS) • Quality of life assessment via the IBS-QoL questionnaire • Overall assessment of improvement in gut health through a 7-staged scale (Patient Global Impression of Improvement Scale - PGI-I) • Global assessment of efficacy • Reduced use of loperamide, Buscopan® and meveberin as an emergency medication to treat the symptoms of IBS-D or IBS-M • Compliance (amount of consumed study medication);Primary end point(s): Efficacy is assessed by a responder criterion, which is different for patients with IBS-D and IBS-M. For both subgroups a response of abdominal pain (NRS pain) is required: • A responder is defined as a patient who has a decrease in abdominal pain by at least 30% from the value in the 2-week run-in phase before randomization in the 2-week control period at the end of the treatment phase. For patients of group IBS-D an additional assessment of stool consistency is required (Bristol stool scale): • A stool consistency responder is defined as a patient who has a decrease in days with at least one stool consistency 6 or 7 by at least 50% over the run-in phase during the 2-week control period at the end of the treatment phase. In addition, for patients in the IBS-M group, an overall assessment of improvement in gut health based on the PGI-I scale is required: • Responder for improvement in gut state of health is defined as a patient who, during the 2-week control period at the end of the treatment phase has an improvement state 1 or 2 (much better | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • abdominal pain (NRS pain measured by a numeric 11-point rating scale, pain intensity 0-10), daily entry in the patient's diary, query at visits 1-5 at the trial center • Number of spontaneous bowel movements, daily based on the patient's entries in the patient diary • Stool consistency measured by the Bristol Stool form Scale survey, daily entry in the patient diary, query at visits 1-5 at the trial center • Number of incidences of the feeling of incomplete defecation daily based on the patient's entries in the patient's diary • Occurrence of mucus and / or blood in the stool, daily entry in the patient diary, query at the visits 1-5 at the trial center • IBS-D or IBS-M symptom severity assessment using the IBS-Severity Scoring System (IBS-SSS) at visits 1-5 (visit survey: completed by the patient) • Quality of life assessment via the IBS-QoL questionnaire at visits 1-5 (visit survey: completed by the patient) • Overall assessment of improvement in gut health through a 7-staged scale (Patient Global Impression of Improvement Scale - PGI-I), query at visit 4 at the trial center • Global assessment of efficacy by investigator and patient at visits 3 and 4 (4-point scale) • Reduced use of loperamide, Buscopan® and meveberin as an emergency medication to treat the symptoms of IBS-D or IBS-M (visits 1 to 5) • Compliance (amount of consumed study medication) on presence visits 3 and 4 via drug accountability;Timepoint(s) of evaluation of this end point: • abdominal pain: daily entry in patient diary, visits 1-5 • Spontaneous bowel movements: daily entry in patient diary • Stool consistency: daily entry in patient diary, visits 1-5 • Feeling of incomplete defecation: daily entry in patient diary • mucus and / or blood in the stool: daily entry in patient diary, visits 1- 5 • IBS Severity Scoring System: visits 1-5 • Quality of life: visits 1-5 • Overall assessment of improvement in gut health status: visit 4 • Adversed events throughout the study | — |
Countries
Germany
Contacts
Public ContactClinical Research Project Manager
Mediconomics GmbH
Outcome results
None listed