The Effect of Alpha-lactalbumin on Microbiota Composition

February 19, 2024 updated by: Lo.Li.Pharma s.r.l

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rome
      • Viterbo, Rome, Italy, 01100
        • Centro Polispecialistico Giovanni Paolo I°

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alpha-lactalbumin
Dietary supplement: Alpha-lactalbumin
Oral assumption of two tabs/day containing Alpha-lactalbumin for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of microbiota composition
Time Frame: Change from baseline microbiota composition to 30 days of treatment
Determination of bacterial biodiversity by metagenomics approach
Change from baseline microbiota composition to 30 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo.Li.Pharma s.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREBIO_LAC22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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