Retrospective Study of Intestinal Microbiota in Association With Diabetes

NCT ID: NCT05565651

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 334 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-06-30

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.

Conditions

Dysbiosis Symptoms Linked to Pathology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Fecal microbiota analysis

Data analysis

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

FRANCESCA DI GAUDIO

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lifebrain Cerba Healthcare laboratory network

Guidonia, Roma, Italy

Countries

Italy

Other Identifiers

8/14/2022

Identifier Type: -

Identifier Source: org_study_id