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NCT05674318 Clinical Trial

The Effect of Alpha-lactalbumin on Microbiota Composition

Microbiota Clinical Trial

Official title:
Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05674318
Other study ID # PREBIO_LAC22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date November 30, 2023

Study information
Verified date June 2023
Source Lo.Li.Pharma s.r.l
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date November 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: - condition of dysbiosis Exclusion Criteria: - antibiotic treatment within 1 month - probiotic or prebiotic treatments - concomitant inflammatory intestinal diseases - pregnancy - neoplastic diseases - allergy to milk protein (Alpha-lactalbumin) - substance abuse

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Alpha-lactalbumin
Oral assumption of two tabs/day containing Alpha-lactalbumin for 30 days

Locations
Country Name City State
Italy Centro Polispecialistico Giovanni Paolo I° Viterbo Rome

Sponsors (1)
Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of microbiota composition Determination of bacterial biodiversity by metagenomics approach Change from baseline microbiota composition to 30 days of treatment
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