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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbiotic Treatment : probiotic Vivomixx® + prebiotic Orafti®Synergy1 | Experimental | 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. |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic Vivomixx® | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| inflammation | change in inflammation estimated by the serum CRP concentration <6 mg / L | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory cytokines 1 | variation of IL-6 | At 2, 4 and 6 months after the start of treatment. |
| inflammatory cytokines 2 | variation of IL-1β |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Recruiting | Besançon | 25000 | France |
Individual data can be provided on request after validation by the competent regulatory authorities.
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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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.
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|
| prebiotic Orafti®Synergy1 | Biological | 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). |
|
| Placebo | Other | Placebo |
|
| At 2, 4 and 6 months after the start of treatment. |
| inflammatory cytokines 3 | variation of TNF-α | At 2, 4 and 6 months after the start of treatment. |
| inflammatory cytokines 4 | variation of IL-10 | At 2, 4 and 6 months after the start of treatment. |
| inflammatory cytokines 5 | variation of IL-8 | At 2, 4 and 6 months after the start of treatment. |
| inflammatory cytokines 6 | variation of IFNγ | At 2, 4 and 6 months after the start of treatment. |
| inflammatory circulating monocytes | variation | At 2, 4 and 6 months after the start of treatment. |
| intestinal microbial metabolome | modification of the intestinal microbial metabolome (Nuclear magnetic resonance) | At 2, 4 and 6 months after the start of treatment. |
| intestinal membrane permeability | modification of LPS | At 2, 4 and 6 months after the start of treatment. |
| bacterial translocation 1 | modification of CD14s | At 2, 4 and 6 months after the start of treatment. |
| bacterial translocation 2 | modification of iFABP | At 2, 4 and 6 months after the start of treatment. |
| health-related quality of life | 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. | At 2, 4 and 6 months after the start of treatment. |
| fragility | fragility (= 3 of the following 5 criteria: undernutrition, grip strength and walking speed, assessed exhaustion and physical activity) | At 2, 4 and 6 months after the start of treatment. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |