Symbiotics and Systemic Inflammation in Chronic Kidney Disease (SISMIC)
Chronic Renal Failure, Diabete Type 2, Systemic Inflammation
About this trial
This is an interventional treatment trial for Chronic Renal Failure focused on measuring Inflammation, Chronic renal failure, Symbiotic
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- CHU de BesançonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Symbiotic Treatment : probiotic Vivomixx® + prebiotic Orafti®Synergy1
Placebo
The prebiotic, Orafti®Synergy1, is made from a volume-to-volume mixture of oligofructoses and Raftiline HP. Orafti®Synergy1 is a slightly sweet white powder packaged in 5 g sachets that can be administered orally. The dose used is 2 sachets per day (morning and evening) for 8 weeks (56 days). The probiotic, Vivomixx®, consists of 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus and L. delbrueckii subsp. Bulgaricus) from 3 strains of Bifidobacterium (B. longum, B. breve, and B. infantis) and a strain of streptococcus (S. salivarius subsp thermophilus). Vivomixx® is in powder form packaged in sachets of 4.5.1011 bacteria which can be administered orally. The dose used is 2 sachets per day (morning and evening) for 8 weeks (56 days). For the study, the symbiotics will be packaged by the probiotic manufacturer in the same sachet (at the same doses as mentioned above) whether for the symbiotics or for the placebo.