Metabolomic Effects of Probiotics Administration

Metabolomic Profile Clinical Trial

— MAPPINg  

Official title:

Effects of Probiotics Administration on Human Metabolic Phenotype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506385
• Other study ID #: 294/CE
• Status: Completed
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2023
• Source: Probiotical S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 31, 2021
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolomic Profile

Intervention

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).

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera-Universitaria Maggiore della carità di Novara	Novara	Piemonte

Sponsors (2)

Lead Sponsor	Collaborator
Probiotical S.p.A.	University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	20 days