Clinical Trials Register

Summary
EudraCT Number:	2016-002550-20
Sponsor's Protocol Code Number:	AMIRA
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2016-09-30
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2016-002550-20

A.3

Full title of the trial

Allogeneic microbiota-reconstitution (AMR) for the Treatment of patients with diarrhea-predominant irritable bowel Syndrome (IBS-D) - the AMIRA trial

Placebo-kontrollierte, oligozentrische Studie zur allogenen Mikrobiom-Rekonstitution (AMR) als neuem Therapieansatz in der Behandlung von Patienten mit Reizdarmsyndrom vom Diarrhoe-dominanten Typ

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Fecal bacteriotherapy for patients with diarrrhea-dominant irritable bowel syndrome

Stuhltransplantation bei Reizdarmpatienten vom Durchfall-Typ

A.3.2

Name or abbreviated title of the trial where available

AMIRA-trial

AMIRA-Studie

A.4.1

Sponsor's protocol code number

AMIRA

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University of Ulm
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Deutsche Forschungsgesellschaft
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Hospital Ulm
B.5.2	Functional name of contact point	Department of Internal Medicine I
B.5.3	Address:
B.5.3.1	Street Address	Albert-Einstein-Allee 23
B.5.3.2	Town/ city	Ulm
B.5.3.3	Post code	89081
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49731500-44501
B.5.5	Fax number	+49731500-44502
B.5.6	E-mail	thomas.seufferlein@uniklinik-ulm.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Stool suspension
D.3.4	Pharmaceutical form	Oral/rectal suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraduodenal use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	reconstituted stool suspension
D.3.9.2	Current sponsor code	AMIRA
D.3.10	Strength
D.3.10.1	Concentration unit	billion CFU billion colony forming units
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Suspension for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Intraduodenal use (Noncurrent)

E. General Information on the Trial

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

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

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

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

standard therapy

Standardtherapie

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-07-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-22

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-04-04

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