Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
1
Patient with short bowel syndrome treated with antibiotics for a bacterial infection
Key facts
- Sponsor
- CHRU De Nancy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 17 Jun 2022 → ongoing
- Decision date (initial)
- 2024-09-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515136-72-00
- EudraCT number
- 2021-001468-13
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patient with short bowel syndrome treated with antibiotics for a bacterial infection
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHRU De Nancy
- Sponsor organisation
- CHRU De Nancy
- Address
- Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Bp 60034 29 Avenue Du Mal De Lattre De Tassigny Bp 60034
- City
- Nancy Cedex
- Postcode
- 54035
- Country
- France
Scientific contact point
- Organisation
- CHRU De Nancy
- Contact name
- Dr. Niasha MICHOT
Public contact point
- Organisation
- CHRU De Nancy
- Contact name
- Dr. Niasha MICHOT
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
CHRU De Nancy
Endocrinology Diabetology and Nutrition, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2022-06-17 | 2022-12-09 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-29 | France | Acceptable 2024-08-07
|
2024-09-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-19 | France | Acceptable 2025-12-15
|
2025-12-15 |