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Metabolomic Effects of Probiotics Administration

NCT04506385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-01-25

No results posted yet for this study

Summary

Background: The establishment of the beneficial interactions between the host and its microbiota is essential for the development and correct functioning of the organism, since microflora alterations can lead to many chronic degenerative diseases. In this context, probiotics are used to improve balanced microbial communities and therefore exert substantial health-promoting effects to the host.

Objective: The aim of the present study is to monitor the molecular outcomes, obtained by gut microflora modulation through probiotic treatment, on human urine and serum metabolic profiles, with a 1H-Nuclear Magnetic Resonance -based metabolomic approach.

Conditions

  • Metabolomic Profile

Interventions

DIETARY_SUPPLEMENT

probiotics

In the first phase: 10 subjects have added in the diet a daily dose of 1 billion of freeze-dried LDD01 probiotics (A arm), 12 individuals are supplemented with a daily dose of 1 billion of the DLBL mix (B arm). In the second phase: 10 individuals are supplemented with a daily low dose of probiotics blend (C arm) and 10 individuals are supplemented with a daily high dose of probiotics blend (D arm).

Sponsors & Collaborators

  • University of Florence

    collaborator OTHER

  • Probiotical S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-20
Primary Completion
2020-07-31
Completion
2021-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04506385 on ClinicalTrials.gov