NCT04768309: GUTCOL

Impact of Intestinal Microbiota on Uremic Toxins Productions

Completed NA Last updated 19 December 2025

What this trial tests

NA trial testing Ex vivo exploration of the effect of a probiotic over precursor indole production in CKD in 20 participants. Completed in 13 July 2021.

Timeline

4 June 2021

Primary endpoint
13 July 2021

13 July 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	20
Start date	4 June 2021
Primary completion	13 July 2021
Estimated completion	13 July 2021
Sites	1 location across France

Drugs / interventions tested

• Ex vivo exploration of the effect of a probiotic over precursor indole production

Conditions studied

• CKD — all drugs for CKD →
• Uremia — all drugs for Uremia →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 80, any sex, with CKD or Uremia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A specifically designed multi-biotic reduces uremic toxin generation and improves kidney function.
   Beau A, Natividad J, Benoit B, Delerive P, et al · · 2025 · cited 5× · PMID 40650408 · DOI 10.1080/19490976.2025.2531202
2. Allies or Enemies? The Power of Plant Hormones in Animals: Insights into Their Regulatory Roles.
   Kućko A, Walczak A, Wilmowicz E, Wolski B, et al · · 2025 · PMID 40733250 · DOI 10.3390/molecules30142984