Chronic Renal FailurePhase 2SISMICNCT04769687
Symbiotics and Systemic Inflammation in Chronic Kidney Disease
A Phase 2 study testing probiotic Vivomixx® and prebiotic Orafti®Synergy1 in people with Chronic Renal Failure and Diabete Type 2, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Renal Failure, Diabete Type 2, Systemic Inflammation
- What is being tested?
- probiotic Vivomixx® and prebiotic Orafti®Synergy1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2020to 1 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
GAIFFE Emilie, 03 81 66 81 66 ext. +33, egaiffe@chu-besancon.fr
About this study
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.
Read the 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.
- Conditions
- Chronic Renal Failure, Diabete Type 2, Systemic Inflammation
- Being tested
- probiotic Vivomixx®, prebiotic Orafti®Synergy1, Placebo
- Keywords
- Inflammation, Chronic renal failure, Symbiotic
- Medical subject headings
- Kidney Failure, Chronic, Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
prebiotic Orafti®Synergy1Biological
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).
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: probiotic Vivomixx®; Biological: prebiotic Orafti®Synergy1 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation
change in inflammation estimated by the serum CRP concentration <6 mg / L
Measured: 4 months
Secondary outcomes (13)
inflammatory cytokines 1
variation of IL-6
Measured: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 2
variation of IL-1β
Measured: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 3
variation of TNF-α
Measured: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 4
variation of IL-10
Measured: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 5
variation of IL-8
Measured: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 6
variation of IFNγ
Measured: At 2, 4 and 6 months after the start of treatment.
inflammatory circulating monocytes
variation
Measured: At 2, 4 and 6 months after the start of treatment.
intestinal microbial metabolome
modification of the intestinal microbial metabolome (Nuclear magnetic resonance)
Measured: At 2, 4 and 6 months after the start of treatment.
intestinal membrane permeability
modification of LPS
Measured: At 2, 4 and 6 months after the start of treatment.
bacterial translocation 1
modification of CD14s
Measured: At 2, 4 and 6 months after the start of treatment.
bacterial translocation 2
modification of iFABP
Measured: 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.
Measured: 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)
Measured: At 2, 4 and 6 months after the start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start21 Nov 2020
- Primary completion1 May 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769687
- Sponsor's protocol ID
- API/2016/76 2019-A00850-57
- Acronym
- SISMIC
- Status last verified
- Jul 2022
- First submitted
- 4 Sep 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data can be provided on request after validation by the competent regulatory authorities.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symbiotics and Systemic Inflammation in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04769687
- Acronym / sponsor ID
- SISMIC / API/2016/76 2019-A00850-57
- Conditions
- Chronic Renal Failure, Diabete Type 2, Systemic Inflammation
- Keywords
- Inflammation, Chronic renal failure, Symbiotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 21 Nov 2020 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Symbiotic Treatment : probiotic Vivomixx® + prebiotic Orafti®Synergy1 | Experimental | Biological: probiotic Vivomixx®, Biological: prebiotic Orafti®Synergy1The 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 | Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Symbiotic Treatment : probiotic Vivomixx® + prebiotic Orafti®Synergy1 |
| prebiotic Orafti®Synergy1Orafti®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). | Biological | Symbiotic Treatment : probiotic Vivomixx® + prebiotic Orafti®Synergy1 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
inflammation
Time frame: 4 months
change in inflammation estimated by the serum CRP concentration <6 mg / L
13 secondary outcomes
inflammatory cytokines 1
Time frame: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 2
Time frame: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 3
Time frame: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 4
Time frame: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 5
Time frame: At 2, 4 and 6 months after the start of treatment.
inflammatory cytokines 6
Time frame: At 2, 4 and 6 months after the start of treatment.
inflammatory circulating monocytes
Time frame: At 2, 4 and 6 months after the start of treatment.
intestinal microbial metabolome
Time frame: At 2, 4 and 6 months after the start of treatment.
intestinal membrane permeability
Time frame: At 2, 4 and 6 months after the start of treatment.
bacterial translocation 1
Time frame: At 2, 4 and 6 months after the start of treatment.
bacterial translocation 2
Time frame: At 2, 4 and 6 months after the start of treatment.
health-related quality of life
Time frame: At 2, 4 and 6 months after the start of treatment.
fragility
Time frame: At 2, 4 and 6 months after the start of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No. Individual data can be provided on request after validation by the competent regulatory authorities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing probiotic Vivomixx® and prebiotic Orafti®Synergy1 in people with Chronic Renal Failure and Diabete Type 2, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.