Symbiotics and Systemic Inflammation in Chronic Kidney Disease

Chronic Renal Failure Clinical Trial

— SISMIC  

Official title:

Symbiotics and Systemic Inflammation in Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04769687
• Other study ID #: API/2016/76 2019-A00850-57
• Status: Recruiting
• Phase: Phase 2
• Start date: November 21, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: November 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Failure
• Diabete Type 2
• Diabetes Mellitus, Type 2
• Inflammation
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Systemic Inflammation

Intervention

Biological:
• probiotic 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.
• prebiotic 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).

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammation	change in inflammation estimated by the serum CRP concentration <6 mg / L	4 months
Secondary	inflammatory cytokines 1	variation of IL-6	At 2, 4 and 6 months after the start of treatment.
Secondary	inflammatory cytokines 2	variation of IL-1ß	At 2, 4 and 6 months after the start of treatment.
Secondary	inflammatory cytokines 3	variation of TNF-a	At 2, 4 and 6 months after the start of treatment.
Secondary	inflammatory cytokines 4	variation of IL-10	At 2, 4 and 6 months after the start of treatment.
Secondary	inflammatory cytokines 5	variation of IL-8	At 2, 4 and 6 months after the start of treatment.
Secondary	inflammatory cytokines 6	variation of IFN?	At 2, 4 and 6 months after the start of treatment.
Secondary	inflammatory circulating monocytes	variation	At 2, 4 and 6 months after the start of treatment.
Secondary	intestinal microbial metabolome	modification of the intestinal microbial metabolome (Nuclear magnetic resonance)	At 2, 4 and 6 months after the start of treatment.
Secondary	intestinal membrane permeability	modification of LPS	At 2, 4 and 6 months after the start of treatment.
Secondary	bacterial translocation 1	modification of CD14s	At 2, 4 and 6 months after the start of treatment.
Secondary	bacterial translocation 2	modification of iFABP	At 2, 4 and 6 months after the start of treatment.
Secondary	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.
Secondary	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.