Clinical trial for examination of efficacy and safety of MYRRHINIL-INTEST® versus placebo in patients with diarrhea-dominant irritable bowel syndrom (IBS-D)

Phase 1

• Conditions: Confirmed diagnosis of diarrhea-dominant irritable bowel syndrome (IBS-D) by a specialist physician and/or internal medicine and/or general medicine; 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]

• Registration Number: EUCTR2019-000307-32-DE
• Lead Sponsor: Repha GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-04
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

•Patients of both sexes aged =18 and = 75 years
•confirmed IBS-D diagnostic to visit 1
•performed colon examination (coloscopy) by patients > 55 years within the last 5 years before study participation
• stool frequency: before visit 1 (screening) in the last 7 days on at least 3 days 1 watery stool/day
•Evaluation of the IBS-D symptoms:
o NRS pain > 3 points at visit 1 and visit 2
o stool consistency documented by the patient using the Bristol stool form scale to visit 1 and 2
•Stool sample analysis for exclusion of blood in stool (faecal occult blood) and exclusion of Clostridium difficile infection by Glutamate-dehydrogenase- (GDH-) ELISA by inclusion in the study (results at visit 2)
•Presence of an informed 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 childbearing persons
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

shortened due to character limit:
a) Diseases
1. confirmed diagnosis of microscopic colitis, ulcerative colitis or Crohn's disease
2. confirmed diagnosis of constipation subtype IBS (IBS-C), mixed-type IBS (IBS-M) or undefined IBS (IBS-U)
3. Since disease: weight loss in the last 6 months (clinically significant, at the investigator's discretion), nocturnal symptoms, anamnesis by first degree relatives with colon carcinoma
4. suspicion of acute appendicitis
5. if stool tests have been performed in the previous 6 months prior to inclusion in the study:
- positive test for blood in stool (except for admixtures due to hemorrhoids or traces of blood due to local irritation due to frequent defecation)
- positive test for parasites and worm eggs
- clinically relevant increased calprotectin values (> 50 µg/g) in stool
6. diagnosed infectious gastroenteritis
7. known anomalies of the gastrointestinal tract (e.g. megacolon) or known diseases resulting in an altered gastrointestinal passage (e. g. colonic polyps)
8. liver or kidney dysfunction (serum creatinine, serum AST or ALT at least 3 times above the reference value in the last 12 months prior to inclusion in the study and during the study)
9. patients with known or suspected gallbladder inflammation (cholecystitis), gallstones, bile acid malabsorption, obstruction of the bile ducts or other gallbladder diseases, sphincter oddi dysfunction or abdominal adhesions
10. past or suspected pancreatitis, ileus or gastrointestinal bleeding
11. endometriosis
12. patients with gastroesophageal reflux disease (GERD) above 2b
13. known or suspected other reasons for diarrhoea: celiac disease; fructose, lactose, sorbitol intolerance or other intolerances
14. 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
15. known autoimmune diseases in the gastrointestinal tract
16. immunocompromised patients
17. condition after partial colon resections
18. diabetes mellitus, type I and/or type II
19. inappropriate medication setting with known hyper- or hypothyroidism, Hashimoto's thyroiditis or signs of thyroid dysfunction
20. hypersensitivity to chamomile, other daisies, myrrh, coffee charcoal, chamomile flowers or one of the other components of the test medication or the placebo.
21. hereditary problems of fructose / galactose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency
22. 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
b) Medication (shortened due to character limit)
1. taking neuroleptics
2. taking antibiotics
3. taking of systemic corticosteroids
4. taking medication to treat IBS-D (exception of study medication and emergency medication)
5. continued use of NSAID for more than 14 days (except for low-dose NSAID for thrombosis prevention or treatment of AEs)
6. intake of opioid till 1 month before study start and during study participation
7. intake of cardiac glycosides

c) General anamnesis
1. patients who participated or are participating (screening) in other clinical trials 30 days prior to the initial inclusion examination or during the clinical trial, or who previously participated in the same trial (randomization)
2. patients with a dis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified