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CompletedNCT05565651Updated Oct 4, 2022

Retrospective Study of Intestinal Microbiota in Association With Diabetes

An observational study in Dysbiosis Symptoms Linked to Pathology, sponsored by University of Palermo. Completed at 1 site in Italy. Open to participants aged 16 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-04.

Sponsored by University of Palermo · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
334
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Dysbiosis Symptoms Linked to Pathology

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Keywords

  • Microbiote
  • Dysbiosis
03

In context

Dysbiosis

196 studies on the registry are indexed under Dysbiosis; 62 are open to participants now.

This study's enrollment of 334 is above the median of 90 across 52 observational studies indexed under Dysbiosis.

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Lead sponsor

University of Palermo is the lead sponsor of 145 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
334 participants (actual)
Patient registry
No

Interventions

  • OtherFecal microbiota analysis

    Data analysis

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What researchers measure

Primary outcomes

  1. Outcome percentage Phyla

    Change in the percentage of Proteobacteria in type 2 diabetic patients

    Time frame: 2020-2022

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Study locations

1 site
  • Lifebrain Cerba Healthcare laboratory network
    Guidonia, Roma 00012, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05565651
Responsible party
FRANCESCA DI GAUDIO (Researcher, University of Palermo) — Principal investigator
First posted
Oct 4, 2022
Start date
Jan 1, 2020
Primary completion
Jan 1, 2022
Completion
Jun 30, 2022
Last update
Oct 4, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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