E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
diarrhea-predominant irritable bowel syndrome |
Reizdarmsyndrom vom Diarrhoe-dominanten Typ |
|
E.1.1.1 | Medical condition in easily understood language |
diarrhoe-predominant irritable bowel syndrome |
Reizdarmsyndrom vom Durchfalltyp |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Improvement of symptom severity of IBS-patients |
Symptomverbesserung bei Reizdarmpatienten |
|
E.2.2 | Secondary objectives of the trial |
safety Quality of Life changes of microbiom |
Sicherheitsaspekte Lebensqualität Veränderungen des Mikrobioms |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age 18-70 years old written informed consent Irritable bowel Syndrome of diarrhea-predominant type according to ROME III criteria duration of symptoms > 1 year before study inclusion persistent symptoms for > 1 year before study inclusion relevant ailments or symptoms resulting in the reduction in the quality of life according to the IBS-QOL Questionnairs (Score < 60 Points) in the last 6 months before study inclusion no specific findings in gastroscopy and colonoscopy in the last 2 years |
Alter 18-70 Jahre unterschriebene Einwilligung Reizdarmsyndrom vom Diarrhoe-dominanten Typ entsprechend der ROME III Kriterien Dauer der Symptome > 1 Jahr vor Studieneinschluss Anhaltende Beschwerden > 1 Jahr vor Studieneinschluss Relevante Beschwerden und Symptome entsprechend einer reduzierten Lebensqualität nach den IBS-QOL Fragebogen (Score < 60 Punkte) in den letzten 6 Monaten vor Studieneinschluss keine Auffälligkeiten in einer Gastroskopie/Koloskopie in den letzten 2 Jahren |
|
E.4 | Principal exclusion criteria |
chronic inflammatory diseases gastrointestinal infectious diseases microscopic colitis celiac disease Diarrhoea due to suspected fructose or lactose intolerance Presence of gastrointestinal malignancy or intestinal polyps irritable bowel Syndrome of other type then IBS-D Presence of Bile acid diarrhoea (BAD) constipation Abdominal ailment or symptom caused by conditions other then IBS-D dementia Recent abdominal operations antibiotic therapy in the last 3 months pregnancy Unwillingness to use proven highly effective contraceptive methods by a woman with child-bearing potential for the duration of the study Concurrent participation in another clinical study Inability to provide informed consent |
chronisch-entzündliche Darmerkrankungen infektiöse Darmerkrankungen kollagenen/lymphozytären colitis Sprue Durchfälle, die durch das Vorliegen einer Fructose- oder Lactoseintoleranz verursacht sind Voliegen eines gastrointestinalen Malignoms oder intestinaler Polypen Reizdarmsyndrom eines anderen Typs außer IBS-D Vorliegen von chologenen Diarrhoen Obstipation Beschwerden oder Symptome durch andere Erkrankungen als IBS-D Demenz Kürzlich zurück liegende Operation im Bereich des Abdomens Antibiotika-Einnahme in den letzten 3 Monaten Schwangerschaft Fehlende Bereitschaft gebärfähiger Frauen für die Dauer der Studienteilnahme eine hocheffektiven Kontrazeptionsmethode anzuwenden Gleichzeitige Teilnahme an einer anderen Studie Sprachliche Barriere bei Einwilligung |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Significant decrease of IBS-SSS |
Abfall des IBS-SSS |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 months after intervention |
3 Monate nach Intervention |
|
E.5.2 | Secondary end point(s) |
Improvement of IBS-QOL Safety aspects changes and acceptance of donor microbiome |
Verbesserung des IBS-QOL Sicherheitsaspekte Veränderungen des Mikrobioms des Empfängers und Akzeptanz des Spendermikrobioms |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 year after intervention |
1 Jahr nach Intervention |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
end of study: one year after the last intervention |
geplantes Studienende: 1 Jahr nach der letzten Intervention |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |