Retrospective Study of Intestinal Microbiota in Association With Diabetes

Sponsor

University of Palermo (Other)

Overall Status

Completed

CT.gov ID

NCT05565651

Collaborator

(none)

334

Enrollment

Location

29.9

Actual Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysbiosis Symptoms Linked to Pathology	Other: Fecal microbiota analysis

Study Design

Study Type:

Observational

Actual Enrollment :

334 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jun 30, 2022

Outcome Measures

Primary Outcome Measures

Outcome percentage Phyla [2020-2022]
Change in the percentage of Proteobacteria in type 2 diabetic patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 80 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lifebrain Cerba Healthcare laboratory network	Guidonia	Roma	Italy	00012

Sponsors and Collaborators

University of Palermo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

FRANCESCA DI GAUDIO, Researcher, University of Palermo

ClinicalTrials.gov Identifier:

NCT05565651

Other Study ID Numbers:

8/14/2022

First Posted:

Oct 4, 2022

Last Update Posted:

Oct 4, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by FRANCESCA DI GAUDIO, Researcher, University of Palermo

Microbiote

Dysbiosis

Additional relevant MeSH terms:

Dysbiosis

Study Results

No Results Posted as of Oct 4, 2022