NCT07893691Toborzás még nem indult
Microbiota Changes Related to Outcomes in Kidney Transplantation
Microbiota Modifications After Kidney Transplantation: Impact on Immunomodulation and Clinical Outcomes
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 26.
Rövid összefoglaló (regiszter, angolul)
Chronic kidney disease affects approximately 10% of the world population. End-stage renal disease (ESRD) is associated with immune dysregulation, chronic inflammation, and alteration of the gut and urinary microbiota. Kidney transplantation is the reference treatment for ESRD, but required immunosuppressive therapy further aggravates immune dysregulation and is associated with cardiovascular, metabolic and infectious complications. The gut microbiota plays a central role in modulating systemic immunity. In ESRD, microbiota composition is strongly altered. A recent study showed an association between gut dysbiosis and all-cause mortality in over 1,300 kidney transplant recipients. However, the mechanisms underlying deleterious microbiota modifications in transplant recipients remain poorly understood, particularly the respective roles of immunosuppressive treatment and renal function recovery. The MICRO-KT study hypothesizes that the programmed introduction of immunosuppressive therapy followed by partial or complete correction of ESRD after living-donor kidney transplantation induces quantitative and qualitative modifications of the fecal microbiota, and that specific microbial signatures are associated with clinical and immunological transplant outcomes. This prospective, single-center, longitudinal, interventional, single-arm cohort study will evaluate microbiota dynamics in 30 adult patients before and after living-donor kidney transplantation. Fecal samples are collected at 14 days before transplantation (before immunosuppression), the day before transplantation (after 4 days of immunosuppression), and 3 months post-transplantation. Urinary samples are collected at transplantation. Blood samples (serum, plasma, PBMCs) are collected at 3 timepoints for immunological and metabolomic analyses. The primary endpoint is to describe fecal microbiota beta-diversity dynamics (Bray-Curtis and Jaccard indices at genus level) across three timepoints. Secondary objectives evaluate associations between microbiota composition and clinical outcomes (rejection, infection, survival), immunosuppressant tolerance, drug levels, PBMC immunological profiles, metabolomic signatures, and dietary patterns.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2026. okt. 19.
- Kezdés
- 2027. jan. 1.
- Elsődleges befejezés
- 2028. okt. 15.
- Fő szponzor
- Hospices Civils de Lyon
- Betegségek
- Krónikus vesebetegség
- NCT-szám
- NCT07893691
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 30
- 2027. jan. 1. és az elsődleges befejezés (2028. okt. 15.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Persons receiving psychiatric care or under legal protection (guardianship, curatorship)
- ABO-incompatible kidney transplantation
- Ongoing immunosuppressive treatment or discontinued less than 3 months ago (conventional treatments) or less than 6 months ago (immunosuppressive immunotherapy)
- Antibiotic therapy within 3 weeks before inclusion
- History of bariatric surgery or gastrointestinal tract resection (excluding appendectomy or cholecystectomy performed more than 12 months prior)
Más betegség
- Chronic inflammatory bowel disease
Egyéb
- Pregnant, parturient, or breastfeeding women
- Persons deprived of liberty by judicial or administrative decision
- Persons not affiliated with a social security scheme or equivalent
- Currently participating in another interventional study with an exclusion period still in effect and potentially interfering with the present study, per investigator judgment
Kiket keres a vizsgálat
- Adult patient (18 years of age or older)
- Living-donor kidney transplantation
- Initial triple immunosuppressive maintenance therapy: calcineurin inhibitor (tacrolimus) + purine synthesis inhibitor (mycophenolate mofetil) + steroids
- Women of childbearing age: effective contraception required (required by the transplantation procedure and -immunosuppressive treatment, not by the study protocol itself)
- Able to understand study objectives and risks and to provide dated signed written informed consent
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Service de Transplantation, Néphrologie et Immunologie Clinique, Hôpital Edouard Herriot | Lyon | Franciaország | Ismeretlen állapot |
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