NCT04361097

Fecal Microbiota Transplantation as a Therapeutic Strategy in the Progression of Chronic Kidney Disease

Completed NA Last updated 28 April 2020

What this trial tests

NA trial testing Faecal microbiota transplant in Chronic Kidney Disease Due to Hypertension in 28 participants. Completed in 21 April 2020.

Timeline

7 August 2018

Primary endpoint
7 November 2019

21 April 2020

Quick facts

Lead sponsor	Hospital Universitario Dr. Jose E. Gonzalez
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	28
Start date	7 August 2018
Primary completion	7 November 2019
Estimated completion	21 April 2020
Sites	1 location across Mexico

Drugs / interventions tested

• Faecal microbiota transplant — full drug profile →
• Placebo

Conditions studied

• Chronic Kidney Disease Due to Hypertension — all drugs for Chronic Kidney Disease Due to Hypertension →
• Chronic Kidney Disease Due to Type 2 Diabetes Mellitus — all drugs for Chronic Kidney Disease Due to Type 2 Diabetes Mellitus →

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Who can join

18 and older, any sex, with Chronic Kidney Disease Due to Hypertension or Chronic Kidney Disease Due to Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

What the investigators want to achieve with the protocol is to identify the impact of intestinal microbiota transplantation on the progression of chronic kidney disease.

Hypothesis: Modification of intestinal microbioma of CKD patients by TMF decrease the progression of CKD Methodological design: Experimental, prospective, double-blind. Inclusion criteria: Being diagnosed with CKD and creatinine clearance less than 60 mL/minute secondary hypertension and/or diabetes and older than 18 years

Publications & conference data

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

1. Changes in the Progression of Chronic Kidney Disease in Patients Undergoing Fecal Microbiota Transplantation.
   Arteaga-Muller GY, Flores-Treviño S, Bocanegra-Ibarias P, Robles-Espino D, et al · · 2024 · cited 34× · PMID 38674803 · DOI 10.3390/nu16081109
2. Acute Kidney Injury and Gut Dysbiosis: A Narrative Review Focus on Pathophysiology and Treatment.
   Chou YT, Kan WC, Shiao CC. · · 2022 · cited 25× · PMID 35409017 · DOI 10.3390/ijms23073658
3. The Links between Microbiome and Uremic Toxins in Acute Kidney Injury: Beyond Gut Feeling-A Systematic Review.
   Rydzewska-Rosołowska A, Sroka N, Kakareko K, Rosołowski M, et al · · 2020 · cited 23× · PMID 33322362 · DOI 10.3390/toxins12120788
4. The Role of Diet and Gut Microbiome in CKD Progression and Therapy.
   Lau WL, Li W, Sumida K, Kalantar-Zadeh K. · · 2026 · PMID 42194897 · DOI 10.3390/jcm15103934
5. Interactions between the gut microbiome and ferroptosis in degenerative diseases: Novel mechanisms and potential therapeutic strategies.
   Chen Y, Wei X, Yi X, Jiang DS. · · 2026 · PMID 42180552 · DOI 10.1016/j.apsb.2026.01.020
6. The gut as a central hub for multi-organ crosstalk in aging.
   Zhang X, Li R, Gao Y, Zhang W, et al · · 2026 · PMID 41787017 · DOI 10.1007/s00018-026-06129-w