Retrospective Study of Intestinal Microbiota in Association With Diabetes

Completed

• Conditions: Dysbiosis Symptoms Linked to Pathology

• Registration Number: NCT05565651
• Lead Sponsor: University of Palermo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-06-30
• Status Verified: 2022-09
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-29
• Last Update Submitted: 2022-09-29
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome percentage Phyla	2020-2022	Change in the percentage of Proteobacteria in type 2 diabetic patients

Trial Locations

Locations (1)

Lifebrain Cerba Healthcare laboratory network; 🇮🇹 Guidonia, Roma, Italy