Alpha-lactalbuminNCT05674318
The Effect of Alpha-lactalbumin on Microbiota Composition
A study testing Alpha-lactalbumin in people with Alpha-lactalbumin and Microbiota, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Alpha-lactalbumin, Microbiota, Dysbiosis
- What is being tested?
- Alpha-lactalbumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2023to 30 Nov 2023
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- condition of dysbiosis
Who cannot join
- antibiotic treatment within 1 month
- probiotic or prebiotic treatments
- concomitant inflammatory intestinal diseases
- pregnancy
- neoplastic diseases
- allergy to milk protein (Alpha-lactalbumin)
- substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition
To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis.
- Conditions
- Alpha-lactalbumin, Microbiota, Dysbiosis
- Being tested
- Alpha-lactalbumin
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-lactalbuminDietary supplement
Oral assumption of two tabs/day containing Alpha-lactalbumin for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Alpha-lactalbumin | Experimental | Not described Receives: Dietary Supplement: Alpha-lactalbumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of microbiota composition
Determination of bacterial biodiversity by metagenomics approach
Measured: Change from baseline microbiota composition to 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start30 Jan 2023
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha-lactalbuminStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674318
- Sponsor's protocol ID
- PREBIO_LAC22
- Status last verified
- Jun 2023
- First submitted
- 21 Dec 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition
- ClinicalTrials.gov ID
- NCT05674318
- Acronym / sponsor ID
- PREBIO_LAC22
- Conditions
- Alpha-lactalbumin, Microbiota, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 6 Jan 2023 (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.
To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha-lactalbumin | Experimental | Dietary Supplement: Alpha-lactalbumin |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- condition of dysbiosis
Key exclusion criteria (7 listed)
- antibiotic treatment within 1 month
- probiotic or prebiotic treatments
- concomitant inflammatory intestinal diseases
- pregnancy
- neoplastic diseases
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 |
|---|---|---|
| Alpha-lactalbuminOral assumption of two tabs/day containing Alpha-lactalbumin for 30 days | Dietary supplement | Alpha-lactalbumin |
Primary outcome
Improvement of microbiota composition
Time frame: Change from baseline microbiota composition to 30 days of treatment
Determination of bacterial biodiversity by metagenomics 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 20 Feb 2024.
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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 Alpha-lactalbumin in people with Alpha-lactalbumin and Microbiota, run by Lo.Li.Pharma s.r.l 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 7 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 20 Feb 2024. 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?
Improvement of microbiota composition (time frame: Change from baseline microbiota composition to 30 days of treatment). 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 20 Feb 2024.