CKDGUTCOLNCT04768309
Impact of Intestinal Microbiota on Uremic Toxins Productions
A study testing Ex vivo exploration of the effect of a probiotic over precursor indole production in people with CKD and Uremia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Chronic renal failure (CKD) affects 3 million people in France and is characterized by the accumulation of uremic toxins (UTs) such as p-cresyl sulfate (PCS) and indoxyl sulfate (IS) which participate in cardiovascular complications and disturbance of the carbohydrate metabolism associated with CKD. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Ex vivo exploration of the effect of a probiotic over precursor indole production
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2021to 13 Jul 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old
- Non diabetic (fasting blood glucose <1.26 g / L, or lack of insulin or oral antidiabetic treatment)
- BMI between 18 and 30 kg / m²
- Patient with CKD stage 4-5 ( eDFG < 30 ml/min/1.73m2 CKD-EPI)
- Not dialyzed
- No history of kidney transplant
- Patient followed in the nephrology department of Pr FOUQUE at the Lyon Sud hospital center
Who cannot join
- Active inflammatory, infectious, cardiovascular or neoplastic disease
- Colectomy, resection of the small intestine or cholecystectomy
- Patient having received antibiotics, prebiotics, probiotics in the last 3 months.
- Patient using laxatives (more than 2 doses per day for the last 3 months)
- Known renal pathology or known urologic malformation (healthy volunteer only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Production of Uremic Toxins by the Gut Microbiota of Patients With Chronic Kidney Disease: in Vitro Test
Chronic renal failure (CKD) affects 3 million people in France and is characterized by the accumulation of uremic toxins (UTs) such as p-cresyl sulfate (PCS) and indoxyl sulfate (IS) which participate in cardiovascular complications and disturbance of the carbohydrate metabolism associated with CKD. These UTs are not eliminated by dialysis due to their high affinity for albumin and alternative strategies to dialysis must be developed to decrease the production of TUs in patients not yet in dialysis. The dysregulation of the intestinal microbiota observed during CKD increases the generation of UTs in the intestine, by the transformation of amino acids derived from proteins (such as tyrosine and tryptophan transformed respectively into PCS and, IS). Thus, modulation of the intestinal microbiota seems to be an attractive target for reducing the production of UTs and the comorbidities associated with CKD. Some studies have demonstrated the potential interest of probiotics in lowering the plasma concentration of UTs, but the effects remain unclear. In order to test the interest of probiotics during CKD, the investigators have, in collaboration with the Nestlé laboratory and the ProDigest platform, the possibility of testing probiotics using a human intestine simulator before the investigation of experimental and human models. For this the investigators would need a collection of fresh stools. The fresh stools will be instilled in artificial intestine to test the efficacy of selected probiotics on UTs production.
- Being tested
- Ex vivo exploration of the effect of a probiotic over precursor indole production
- Keywords
- CKD, uremic toxin, probiotics, intestinal microbiota, artificial intestine
- Medical subject headings
- Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex vivo exploration of the effect of a probiotic over precursor indole productionOther
Fresh feces in chronic kidney patients and healthy volunteers will be collected. The feces will be instilled in artificial intestine with and without selected probiotics and production of uremic toxins will be measured.
| Study group | Role | What they receive |
|---|---|---|
| CKD group | Experimental | CKD adult patients stage 4-5 Without diabetes BMI between 18 and 30 kg/m2 Receives: Other: Ex vivo exploration of the effect of a probiotic over precursor indole production |
| Healthy volunteers group | Other | Adult without chronic treatment, without renal dysfunction Receives: Other: Ex vivo exploration of the effect of a probiotic over precursor indole production |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of precursor of one of major uremic toxins: indole
The main endpoint is the concentration of the precursor of indoxyl sulfate (indole) in the lumen of the artificial intestine with a microbiota of a patient with CKD compared to the concentration of indol in the lumen of artificial intestine with a microbiota from a patient with CKD and supplemented with a probiotic (supplied by Nestlé)
Measured: Indoles production will be measured 48 hours after instillation of fresh feces in the artificial intestine
Secondary outcomes (7)
Uremic toxins production
Concentration of various uremic toxins in a human intestine simulator (p-cresyl sulfate, p-cresol, indole-3-acetic acid, etc.).
Measured: 48 hours after instillation of fresh feces in the human intestine simulator
Production of short-chain fatty acids (SCFA)
Concentration of short-chain fatty acids (SCFA) (acetate, propionate, butyrate, isobutyrate, isovalerate and isocaproate) human intestine simulator
Measured: 48 hours after instillation of fresh feces in the human intestine simulator
Intestinal permeability in a human intestine simulator
It will be measured by the electrical transepithelial resistance of the intestinal cells.
Measured: 48 hours after instillation of fresh feces in the human intestine simulator
Biochemical parameters
Concentration of ammonium and lactate in a human intestine simulator.
Measured: 48 hours after instillation of fresh feces in the human intestine simulator
Biochemical parameters
pH levels of the human intestine simulator.
Measured: 48 hours after instillation of fresh feces in the human intestine simulator
Biochemical parameters
Volume of gas production in a human intestine simulator.
Measured: 48 hours after instillation of fresh feces in the human intestine simulator
Intestinal microbiota composition
Study of the composition of the intestinal microbiota by 16s analysis
Measured: 48 hours after instillation of fresh feces in the human intestine simulator
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 start4 Jun 2021
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768309
- Sponsor's protocol ID
- 69HCL20_1078
- Acronym
- GUTCOL
- Status last verified
- Dec 2025
- First submitted
- 12 Feb 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beau A, Natividad J, Benoit B, Delerive P, Duboux S, Feng Y, Jammes M, Barnel C, Sequino G, Pinteur C, Glorieux G, Fouque D, Vidal H, Koppe L. A specifically designed multi-biotic reduces uremic toxin generation and improves kidney function. Gut Microbes. 2025 Dec;17(1):2531202. doi: 10.1080/19490976.2025.2531202. Epub 2025 Jul 12.
PubMed 40650408
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Production of Uremic Toxins by the Gut Microbiota of Patients With Chronic Kidney Disease: in Vitro Test
- ClinicalTrials.gov ID
- NCT04768309
- Acronym / sponsor ID
- GUTCOL / 69HCL20_1078
- Keywords
- CKD, uremic toxin, probiotics, intestinal microbiota, artificial intestine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- 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.
Chronic renal failure (CKD) affects 3 million people in France and is characterized by the accumulation of uremic toxins (UTs) such as p-cresyl sulfate (PCS) and indoxyl sulfate (IS) which participate in cardiovascular complications and disturbance of the carbohydrate metabolism associated with CKD. These UTs are not eliminated by dialysis due to their high affinity for albumin and alternative strategies to dialysis must be developed to decrease the production of TUs in patients not yet in dialysis. The dysregulation of the intestinal microbiota observed during CKD increases the generation of UTs in the intestine, by the transformation of amino acids derived from proteins (such as tyrosine and tryptophan transformed respectively into PCS and, IS). Thus, modulation of the intestinal microbiota seems to be an attractive target for reducing the production of UTs and the comorbidities associated with CKD. Some studies have demonstrated the potential interest of probiotics in lowering the plasma concentration of UTs, but the effects remain unclear. In order to test the interest of probiotics during CKD, the investigators have, in collaboration with the Nestlé laboratory and the ProDigest platform, the possibility of testing probiotics using a human intestine simulator before the investigation of experimental and human models. For this the investigators would need a collection of fresh stools. The fresh stools will be instilled in artificial intestine to test the efficacy of selected probiotics on UTs production.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD group | Experimental | Other: Ex vivo exploration of the effect of a probiotic over precursor indole productionCKD adult patients stage 4-5 Without diabetes BMI between 18 and 30 kg/m2 |
| Healthy volunteers group | Other | Other: Ex vivo exploration of the effect of a probiotic over precursor indole productionAdult without chronic treatment, without renal dysfunction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 80 years old
- Non diabetic (fasting blood glucose <1.26 g / L, or lack of insulin or oral antidiabetic treatment)
- BMI between 18 and 30 kg / m²
- Patient with CKD stage 4-5 ( eDFG < 30 ml/min/1.73m2 CKD-EPI)
- Not dialyzed
Key exclusion criteria (5 listed)
- Active inflammatory, infectious, cardiovascular or neoplastic disease
- Colectomy, resection of the small intestine or cholecystectomy
- Patient having received antibiotics, prebiotics, probiotics in the last 3 months.
- Patient using laxatives (more than 2 doses per day for the last 3 months)
- Known renal pathology or known urologic malformation (healthy volunteer only)
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 |
|---|---|---|
| Ex vivo exploration of the effect of a probiotic over precursor indole productionFresh feces in chronic kidney patients and healthy volunteers will be collected. The feces will be instilled in artificial intestine with and without selected probiotics and production of uremic toxins will be measured. | Other | CKD group, Healthy volunteers group |
Primary outcome
Production of precursor of one of major uremic toxins: indole
Time frame: Indoles production will be measured 48 hours after instillation of fresh feces in the artificial intestine
The main endpoint is the concentration of the precursor of indoxyl sulfate (indole) in the lumen of the artificial intestine with a microbiota of a patient with CKD compared to the concentration of indol in the lumen of artificial intestine with a microbiota from a patient with CKD and supplemented with a probiotic (supplied by Nestlé)
7 secondary outcomes
Uremic toxins production
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Production of short-chain fatty acids (SCFA)
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Intestinal permeability in a human intestine simulator
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Biochemical parameters
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Biochemical parameters
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Biochemical parameters
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Intestinal microbiota composition
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 40650408Beau A, Natividad J, Benoit B, Delerive P, Duboux S, Feng Y, Jammes M, Barnel C, Sequino G, Pinteur C, Glorieux G, Fouque D, Vidal H, Koppe L. A specifically designed multi-biotic reduces uremic toxin generation and improves kidney function. Gut Microbes. 2025 Dec;17(1):2531202. doi: 10.1080/19490976.2025.2531202. Epub 2025 Jul 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ex vivo exploration of the effect of a probiotic over precursor indole production in people with CKD and Uremia, run by Hospices Civils de Lyon 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 19 Dec 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of precursor of one of major uremic toxins: indole (time frame: Indoles production will be measured 48 hours after instillation of fresh feces in the artificial intestine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04768309, which also lists 1 linked publication.
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 19 Dec 2025.