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Clinical Trials/NCT05565651
NCT05565651
Completed
Not Applicable

Retrospective Study for the Characterization of the Intestinal Microbiota in Association With Pathologies and Diet in the Italian Population

University of Palermo1 site in 1 country334 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysbiosis Symptoms Linked to Pathology
Sponsor
University of Palermo
Enrollment
334
Locations
1
Primary Endpoint
Outcome percentage Phyla
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The microbiota interacts with several human organs and influences the physiological process in the host. The predominant Phyla of species in the gut microbiota are Bacteroidetes (B) and Firmicutes (F), accounting for 60-80%, and Proteobacteria (P) and Actinobacteria (A) in minority. When some of the bacterial Phyla species are unbalanced, the pathological state of dysbiosis occurs. A laboratory index used for clinical analyzes is the F / B ratio <0.8, which characterizes an intestinal dysbiotic state.

Many causes can affect the intestinal microbiota, thus altering it in a dysbiotic state, first of all the diet. In fact, dysbiosis can be characterized both by the severity with which it manifests itself and is also distinguished in putrefactive and fermentative dysbiosis.

Furthermore, the variation in the "normal" percentages of the Phyla is also related to some pathological alterations.

The aim of this study will be to monitor the population and heterogeneity of the microbiota in the Italian population. Knowing the complex implications of dysbiosis and the extensive data on it, this study will want to detail the state of the gut microbiota in the previously indicated population, focusing attention on peculiar profiles that could reflect a pathogenic spectrum or metabolic disturbances.

The study aims to investigate the diffusion and state of the microbiota in the Italian territory and if it occurs in association with certain pathologies and / or diet.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

FRANCESCA DI GAUDIO

Researcher

University of Palermo

Eligibility Criteria

Inclusion Criteria

  • Aged between 16 and 80 years old,
  • Patients with completed questionnare
  • Dysbiosis symptoms

Exclusion Criteria

  • Under 16 years old,
  • over 80 years old,
  • patients misidentified

Outcomes

Primary Outcomes

Outcome percentage Phyla

Time Frame: 2020-2022

Change in the percentage of Proteobacteria in type 2 diabetic patients

Study Sites (1)

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