An interventional study of Ex vivo exploration of the effect of a probiotic over precursor indole production in CKD and Uremia, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
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.
53 studies on the registry are indexed under Uremia; 10 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 38 interventional studies indexed under Uremia.
Browse Uremia studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CKD adult patients stage 4-5 Without diabetes BMI between 18 and 30 kg/m2
Other: Ex vivo exploration of the effect of a probiotic over precursor indole production
Adult without chronic treatment, without renal dysfunction
Other: Ex vivo exploration of the effect of a probiotic over precursor indole production
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.
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)
Time frame: Indoles production will be measured 48 hours after instillation of fresh feces in the artificial intestine
Uremic toxins production
Concentration of various uremic toxins in a human intestine simulator (p-cresyl sulfate, p-cresol, indole-3-acetic acid, etc.).
Time frame: 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
Time frame: 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.
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Biochemical parameters
Concentration of ammonium and lactate in a human intestine simulator.
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Biochemical parameters
pH levels of the human intestine simulator.
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
Biochemical parameters
Volume of gas production in a human intestine simulator.
Time frame: 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
Time frame: 48 hours after instillation of fresh feces in the human intestine simulator
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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