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OpenTrials
Completed

NCT Number: NCT05565651

Retrospective Study of Intestinal Microbiota in Association With Diabetes

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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lifebrain Cerba Healthcare laboratory network

Guidonia, Roma, 00012, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal microbiota analysis

Other

Data analysis

Primary outcomes

  1. Outcome percentage Phyla

    Time frame: 2020-2022

    Change in the percentage of Proteobacteria in type 2 diabetic patients

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2022
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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