Status:
UNKNOWN
Renal Effects of Meditarranean Diet and Low-protein Diet With Ketoacids on Physiological Intestinal Mibrobiota in CKD
Lead Sponsor:
Azienda Sanitaria ASL Avellino 2
Conditions:
Chronic Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Food intake has a deep influence on gut microbiota composition and function, both in health and in disease status. In chronic kidney disease (CKD), a microbiota dysbiosis status is observed. Moreover,...
Detailed Description
Background: In CKD the biochemical milieu of gastrointestinal tract (GI) is altered by several mechanisms, affecting gut microbiota composition and function. Beyond exerting metabolic functions, micro...
Eligibility Criteria
Inclusion
- prevalent patients in tertiary nephrology clinic;
- patients over 18 years;
- CKD stage 3b-4 (eGFR between 15 and 45 ml/min/1.73m2, estimated by MDRD formula);
- clinically proven adherence to prescribed therapies;
- informed consent signed.
Exclusion
- change of GFR \>30% within the last 3 months;
- acute, intercurrent disease during the previous 3 months;
- severe undernutrition as indicated by: BMI \< 20 kg/m2 and serum albumin \< 3.2 g/dl, or BMI \< 17.5 kg/m2 whatever albumin value, or body weight reduction \> 5% within the last month or \> 10% within the last six months;
- pregnancy or feeding;
- chronic treatment with steroid or cytotoxic drugs; fast progressing glomerulonephritis; active SLE and vasculitis;
- gastrointestinal diseases (Crohn disease, Ulcerative colitis, Celiac Sprue, Stypsis); 7) infectious diseases; 8) cardiac failure stage III-IV NYHA; advanced liver cirrhosis; active cancer diseases; severe encephalopathy associated with lack of spontaneous feeding; chronic obstructive respiratory diseases needing oxygen treatment; 9) use of antibiotics or probiotics until 15 days before the enrolment; 10) psychiatric disease or inability to assess follow-up.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02302287
Start Date
January 1 2015
End Date
July 1 2017
Last Update
November 28 2016
Active Locations (1)
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1
UOC Nefrologia
Solofra, Avellino, Italy, I-83029