Metabolomic Effects of Probiotics Administration

Probiotical S.p.A.42 enrolled

Overview

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.

Design: In a first phase twenty-two healthy subjects are enrolled in the study and administered with Lactobacillus delbrueckii subs. delbrueckii and/or a mix of 5 biotypes of Bifidobacterium longum for 8 weeks. In the second phase subjects are enrolled in the study and administered with Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus fermentum and Bifidobacterium longum at two different concentration. During the course of the study all the probiotic types were administered both singularly and in combination. From each subject urine and serum samples are collected before and during the supplementation and are analysed by nuclear magnetic resonance spectroscopy and statistical analyses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Metabolomic Profile

Interventions

probioticsDIETARY_SUPPLEMENT

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).

Eligibility

Sex: ALLMin age: 24 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- healthy subjects Exclusion Criteria: * previous surgery on the intestinal tract; * a probiotic / prebiotic and antibiotic treatments within 3 and 1 months, respectively, before the beginning of the study; * subjects have changed drastically their diet or lifestyle during the study.

Locations (1)

Azienda Ospedaliera-Universitaria Maggiore della carità di Novara

Novara, Piedmont, Italy

Outcomes

Primary Outcomes

metabolomic profile

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

Time frame: 20 days

Data from ClinicalTrials.gov

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