Metabolomic ProfileMAPPINgNCT04506385
Metabolomic Effects of Probiotics Administration
A study testing probiotics in people with Metabolomic Profile, run by Probiotical S.p.A. at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 24 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolomic Profile
- What is being tested?
- probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera-Universitaria Maggiore della carità di Novara
Novara, Piedmont, 28100
About this study
Official title: Effects of Probiotics Administration on Human Metabolic Phenotype
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.
Read the 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.
- Conditions
- Metabolomic Profile
- Being tested
- probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 grams | Active comparator | L. delbrueckii LDD01 probiotic bacterial strain Receives: Dietary Supplement: probiotics |
| B - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 grams | Active comparator | Bifidobacterium longum DLBL probiotic bacterial strain Receives: 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 Receives: 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 Receives: Dietary Supplement: probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start20 Apr 2020
- Primary completion31 Jul 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolomic ProfileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probiotical S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florence
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506385
- Sponsor's protocol ID
- 294/CE
- Acronym
- MAPPINg
- Status last verified
- Jan 2023
- First submitted
- 6 Aug 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics Administration on Human Metabolic Phenotype
- ClinicalTrials.gov ID
- NCT04506385
- Acronym / sponsor ID
- MAPPINg / 294/CE
- Conditions
- Metabolomic Profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Probiotical S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- University of Florence
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 grams | Active comparator | Dietary Supplement: probioticsL. delbrueckii LDD01 probiotic bacterial strain |
| B - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 grams | Active comparator | Dietary Supplement: probioticsBifidobacterium longum DLBL probiotic bacterial strain |
| C - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams | Active comparator | Dietary Supplement: probioticsL. 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 | Active comparator | Dietary Supplement: probioticsL. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum BL04: high dosage; probiotic bacterial strains blend |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probioticsIn 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). | Dietary supplement | A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 grams, B - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 grams, C - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams, D - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams |
Primary outcome
metabolomic profile
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Metabolomic Profile, run by Probiotical S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolomic profile (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.