Status:
UNKNOWN
Symbiotics and Systemic Inflammation in Chronic Kidney Disease
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Chronic Renal Failure
Diabete Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Main objective: To assess the effectiveness of treatment with symbiotics on the chronic systemic inflammation observed in chronic renal failure 4 months after the start of treatment.
Detailed Description
During a consultation in the nephrology departments : the study will be presented to the patient and the information leaflet will be given to him. During a subsequent visit, after checking the level ...
Eligibility Criteria
Inclusion
- Men and women aged 18 to 80 inclusive
- Women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
- Signature of the informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
- Affiliation to a French social security scheme or beneficiary of such a scheme.
- Patient with type II diabetes
- Creatinine clearance less than 45 ml / min / 1.73m²
- Serum CRPus level greater than 6 mg / l, evaluated twice from 15 days to 3 months apart
- Patient not opposed to the conservation of biological samples for scientific research purposes.
Exclusion
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
- Subject without health insurance
- Pregnant woman
- Subject being in the period of exclusion from another study or provided for by the "national file of volunteers".
- Infectious episode with need for hospitalization less than 1 month old.
- Active infection with hepatitis B and / or C virus.
- Active or non-progressive infection with HIV.
- Antibiotic therapy in the previous 3 months.
- Anti-inflammatory treatment.
- History of colectomy.
- All chronic digestive pathologies.
Key Trial Info
Start Date :
November 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04769687
Start Date
November 21 2020
End Date
November 1 2023
Last Update
August 3 2022
Active Locations (1)
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1
CHU de Besançon
Besançon, France, 25000