Controlled clinical trial to evaluate the efficacy and safety of MYRRHINIL-INTEST® versus placebo in patients with diarrhea-dominant irritable bowel syndrome (IBS-D) and patients with mixed-type irritable bowel syndrome (IBS-M) - MYNIBOS

Repha GmbH0 sites140 target enrollmentOctober 4, 2019

ConditionsA 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: 20.0Level: LLTClassification code 10023002Term: Irritable bowelSystem Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 26.0Level: LLTClassification code 10060845Term: Diarrhea predominant irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

DrugsMYRRHINIL-INTEST®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: 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
Sponsor: Repha GmbH
Enrollment: 140
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 4, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Repha GmbH

Eligibility 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

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