Symbiotics and Systemic Inflammation in Chronic Kidney Disease

NCT04769687 | Unknown Phase 2

• 1 other identifier: API/2016/76 2019-A00850-57
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure; Diabete Type 2; Systemic Inflammation

Keywords

Inflammation; Chronic renal failure; Symbiotic

Outcome Measures

Primary Outcomes (1)

• inflammation

  change in inflammation estimated by the serum CRP concentration \<6 mg / L

  4 months

Secondary Outcomes (13)

• inflammatory cytokines 1

  At 2, 4 and 6 months after the start of treatment.

• inflammatory cytokines 2

  At 2, 4 and 6 months after the start of treatment.

• inflammatory cytokines 3

  At 2, 4 and 6 months after the start of treatment.

• inflammatory cytokines 4

  At 2, 4 and 6 months after the start of treatment.

• inflammatory cytokines 5

  At 2, 4 and 6 months after the start of treatment.

Study Arms (2)

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.

Biological: probiotic Vivomixx®; Biological: prebiotic Orafti®Synergy1

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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.

Symbiotic Treatment : probiotic Vivomixx® + prebiotic Orafti®Synergy1

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).

Symbiotic Treatment : probiotic Vivomixx® + prebiotic Orafti®Synergy1

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Diabetes Mellitus, Type 2; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: February 24, 2021
• Study Start: November 21, 2020
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)