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Clinical Trials/NCT05565651
NCT05565651CompletedNot 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 enrollmentStarted: January 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
334
Locations
1
Primary Endpoint
Outcome percentage Phyla

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
16 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

FRANCESCA DI GAUDIO

Researcher

University of Palermo

Study Sites (1)

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