Retrospective Study of Intestinal Microbiota in Association With Diabetes

NCT05565651 | Completed

• 1 other identifier: 8/14/2022
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

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

Keywords

Microbiote; Dysbiosis

Outcome Measures

Primary Outcomes (1)

• Outcome percentage Phyla

  Change in the percentage of Proteobacteria in type 2 diabetic patients

  2020-2022

Interventions

Fecal microbiota analysis OTHER

Data analysis

Eligibility Criteria

• Age: 16 Years - 80 Years
• Gender Eligibility Details: Male and Female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

334 fecal samples from Lifebrain Cerba Healthcare Italian laboratory network were analyzed to perform a gut microbiota genetic test, accompanied by filling an attachment to provide a medical history useful for the interpretation of the results obtained and to provide a correct diagnosis using a specific test kit for the stool sample collection. The samples were collected from people aged between 2 and 87 years old.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Lifebrain Cerba Healthcare laboratory network

Guidonia, Roma, 00012, Italy

Location

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 4, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: June 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

IT (1)