Chronic Renal Failure, Diabete Type 2, Systemic Inflammation
Conditions
Keywords
Inflammation, Chronic renal failure, Symbiotic
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 of serum CRP and obtaining the consent of the investigating physician, a blood test will be taken to assess the intestinal permeability and the inflammatory state. A health-related quality of life (SF-36) and frailty questionnaire (previous questionnaire, MNA questionnaire; Mini Nutritional Assessment - Short Form and physical activity question) will be completed by the patient. Two faecal sampling kits (one for D0 and one for M2) will be distributed to patients. During the D0 visit, patients will be randomized into two arms. Both arms will receive the same dietary advice. The intervention group will receive symbiotics (prebiotics: Orafti®Synergy1 and probiotics: Vivomixx®) for 8 weeks against a placebo in the control group. The treatment will begin after the collection of the first stools (kit J0). At the end of the treatment (M2 or 56 days later), a new blood sample will be taken. Two other blood samples will be taken 4 months and 6 months after the start of treatment. Patients will also provide a faecal sample and complete the various questionnaires at the end of treatment (M2), 2 months after (M4) and 4 months after (M6) treatment. The study will have no influence on the management of the patient. It does not require any additional consultation or any particular biological assessment other than that described. Treatments should not be influenced by the study. The samples will be processed without knowledge of the initial characteristics of the patients, nor of their evolution.
Interventions
BIOLOGICALprobiotic Vivomixx®
Vivomixx® is in powder form packaged in sachets of 4.5.1011 bacteria. The dose used is 2 sachets per day (morning and evening) for 8 weeks (56 days). For the study, the symbiotics will be packaged in the same sachet at the same doses as mentioned above.
BIOLOGICALprebiotic Orafti®Synergy1
Orafti®Synergy1 is a slightly sweet white powder packaged in 5 g sachets. The dose used is 2 sachets per day (morning and evening) for 8 weeks (56 days).
OTHERPlacebo
Placebo
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, non-comparative 2: 1 phase 2 study (symbiotic vs placebo) aimed at evaluating the efficacy of the use of symbiotics in reducing chronic inflammation observed in chronic renal failure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammation | 4 months | change in inflammation estimated by the serum CRP concentration \<6 mg / L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory circulating monocytes | At 2, 4 and 6 months after the start of treatment. | variation |
| intestinal microbial metabolome | At 2, 4 and 6 months after the start of treatment. | modification of the intestinal microbial metabolome (Nuclear magnetic resonance) |
| inflammatory cytokines 1 | At 2, 4 and 6 months after the start of treatment. | variation of IL-6 |
| inflammatory cytokines 2 | At 2, 4 and 6 months after the start of treatment. | variation of IL-1β |
| inflammatory cytokines 3 | At 2, 4 and 6 months after the start of treatment. | variation of TNF-α |
| inflammatory cytokines 4 | At 2, 4 and 6 months after the start of treatment. | variation of IL-10 |
| inflammatory cytokines 6 | At 2, 4 and 6 months after the start of treatment. | variation of IFNγ |
| intestinal membrane permeability | At 2, 4 and 6 months after the start of treatment. | modification of LPS |
| bacterial translocation 1 | At 2, 4 and 6 months after the start of treatment. | modification of CD14s |
| bacterial translocation 2 | At 2, 4 and 6 months after the start of treatment. | modification of iFABP |
| health-related quality of life | At 2, 4 and 6 months after the start of treatment. | SF-36 Health Survey (Short Form) The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. |
| fragility | At 2, 4 and 6 months after the start of treatment. | fragility (= 3 of the following 5 criteria: undernutrition, grip strength and walking speed, assessed exhaustion and physical activity) |
| inflammatory cytokines 5 | At 2, 4 and 6 months after the start of treatment. | variation of IL-8 |
Countries
France
Outcome results
None listed