An interventional study of probiotics in Metabolomic Profile, sponsored by Probiotical S.p.A.. Completed at 1 site in Italy. Open to participants aged 24 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Probiotical S.p.A. · Not applicable, Interventional, and Other
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.
Probiotical S.p.A. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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- healthy subjects
Exclusion Criteria:
L. delbrueckii LDD01 probiotic bacterial strain
Dietary Supplement: probiotics
Bifidobacterium longum DLBL probiotic bacterial strain
Dietary Supplement: probiotics
L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum 04: low dosage; probiotic bacterial strains blend
Dietary Supplement: probiotics
L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum BL04: high dosage; probiotic bacterial strains blend
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).
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
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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