NCT04506385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

August 6, 2020

Last Update Submit

January 23, 2023

Conditions

Metabolomic Profile

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

ACTIVE COMPARATOR

L. delbrueckii LDD01 probiotic bacterial strain

Dietary Supplement: probiotics

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

ACTIVE COMPARATOR

Bifidobacterium longum DLBL probiotic bacterial strain

Dietary Supplement: probiotics

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

ACTIVE COMPARATOR

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

Dietary Supplement: probiotics

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

ACTIVE COMPARATOR

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

Dietary Supplement: probiotics

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).

A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 gramsB - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 gramsC - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 gramsD - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams

Eligibility Criteria

Age24 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- healthy subjects

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera-Universitaria Maggiore della carità di Novara

Novara, Piedmont, 28100, Italy

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

April 20, 2020

Primary Completion

July 31, 2020

Study Completion

March 31, 2021

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)