Metabolomic Effects of Probiotics Administration (MAPPINg)

Probiotical

Status: Completed

Conditions: Metabolomic Profile

Treatments: Dietary Supplement: probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04506385

294/CE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 24 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 4 patient groups

A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 grams

Active Comparator group

Description:

L. delbrueckii LDD01 probiotic bacterial strain

Treatment:

Dietary Supplement: probiotics

B - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 grams

Active Comparator group

Description:

Bifidobacterium longum DLBL probiotic bacterial strain

Treatment:

Dietary Supplement: probiotics

C - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams

Active Comparator group

Description:

L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum 04: low dosage; probiotic bacterial strains blend

Treatment:

Dietary Supplement: probiotics

D - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams

Active Comparator group

Description:

L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum BL04: high dosage; probiotic bacterial strains blend

Treatment:

Dietary Supplement: probiotics