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The Effect of Alpha-lactalbumin on Microbiota Composition

Primary Purpose

Alpha-lactalbumin, Microbiota, Dysbiosis

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Alpha-lactalbumin
Sponsored by
Lo.Li.Pharma s.r.l
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alpha-lactalbumin

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Polispecialistico Giovanni Paolo I°

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alpha-lactalbumin

Arm Description

Outcomes

Primary Outcome Measures

Improvement of microbiota composition
Determination of bacterial biodiversity by metagenomics approach

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
September 13, 2023
Sponsor
Lo.Li.Pharma s.r.l
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1. Study Identification

Unique Protocol Identification Number
NCT05674318
Brief Title
The Effect of Alpha-lactalbumin on Microbiota Composition
Official Title
Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alpha-lactalbumin, Microbiota, Dysbiosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alpha-lactalbumin
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha-lactalbumin
Intervention Description
Oral assumption of two tabs/day containing Alpha-lactalbumin for 30 days
Primary Outcome Measure Information:
Title
Improvement of microbiota composition
Description
Determination of bacterial biodiversity by metagenomics approach
Time Frame
Change from baseline microbiota composition to 30 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centro Polispecialistico Giovanni Paolo I°
City
Viterbo
State/Province
Rome
ZIP/Postal Code
01100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

The Effect of Alpha-lactalbumin on Microbiota Composition

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