Clinical trial NCT04769687: Symbiotics and Systemic Inflammation in Chronic Kidney Disease
Official title: Symbiotics and Systemic Inflammation in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Renal Failure
Diabete Type 2
Systemic Inflammation
Keywords: Inflammation
Chronic renal failure
Symbiotic
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: inflammation
timeFrame: 4 months
Secondary outcomes:
measure: inflammatory cytokines 1
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: inflammatory cytokines 2
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: inflammatory cytokines 3
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: inflammatory cytokines 4
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: inflammatory cytokines 5
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: inflammatory cytokines 6
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: inflammatory circulating monocytes
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: intestinal microbial metabolome
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: intestinal membrane permeability
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: bacterial translocation 1
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: bacterial translocation 2
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: health-related quality of life
timeFrame: At 2, 4 and 6 months after the start of treatment.
measure: fragility
timeFrame: At 2, 4 and 6 months after the start of treatment.
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References: