Metabolomic Effects of Probiotics Administration

Not Applicable

Completed

• Conditions: Metabolomic Profile
• Interventions: Dietary Supplement: probiotics

• Registration Number: NCT04506385
• Lead Sponsor: Probiotical S.p.A.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-04-20
• Primary Completion: 2020-07-31
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Study Completion: 2021-03-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 grams	probiotics	L. delbrueckii LDD01 probiotic bacterial strain
B - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 grams	probiotics	Bifidobacterium longum DLBL probiotic bacterial strain
C - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams	probiotics	L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum 04: low dosage; probiotic bacterial strains blend
D - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams	probiotics	L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum BL04: high dosage; probiotic bacterial strains blend

Primary Outcome Measures

Name	Time	Method
metabolomic profile	20 days	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

Trial Locations

Locations (1)

Azienda Ospedaliera-Universitaria Maggiore della carità di Novara; 🇮🇹 Novara, Piemonte, Italy