Study of the absorption of oral antibiotics known for their good ability to cross the barrier of the stomach and intestine to reach the blood in patients with short bowel syndrome

Phase 1

Conditions: Patient with short bowel syndrome treated with antibiotics for urinary parenchymal infection
MedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2021-001468-13-FR

Lead Sponsor: Centre Hospitalier Régional Universitaire de Nancy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 10

Inclusion Criteria

1. Male or female = 18 years of age ; ;
2. Patient with short bowel syndrome
3. Patient treated for urinary parenchymal infection (pyelonephritis / prostatitis) (documented with antibiogram) with SULFAMETHOXAZOLE/TRIMETHOPRIME / AMOXICILLINE (+/- acide clavulanique)/ OFLOXACINE / LEVOFLOXACINE
4. Patient hospitalized in the Nutritional Assistance Unit or in the Infectious and Tropical Diseases Department
5. Patient affiliated with to beneficiary of a social security system;
6. Patient having performed a preliminary clinical examination
7. Patient who signed informed consent
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient at foreseeable risk of degrading their PO absorption capacity during follow-up;
2. Patient on dialysis;
3. Female of childbearing age without effective contraception;
4. Person with a known allergy to one of the components of the evaluated product;
5. Person with a contraindication to (or one of the) evaluated product (s);
6. Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of
the Public Health Code:
o Pregnant women, parturient women or nursing mothers ;
o Minor (non-emancipated)
o Adult person subject to a legal protection measure (guardianship,
curatorship, judicial safeguard);
o Adults person who is unable to give consent and who is not subject
to a legal protection measure;
o Persons deprived of their liberty by a judicial or administrative
decision;
o Persons subject to psychiatric care pursuant to articles L. 3212-1 and
L. 3213-1