The Effect of Alpha-lactalbumin on Microbiota Composition

NCT ID: NCT05674318

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2023-11-30

Brief Summary

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

Detailed Description

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Conditions

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Alpha-lactalbumin Microbiota Dysbiosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Alpha-lactalbumin

Group Type EXPERIMENTAL

Alpha-lactalbumin

Intervention Type DIETARY_SUPPLEMENT

Oral assumption of two tabs/day containing Alpha-lactalbumin for 30 days

Interventions

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Alpha-lactalbumin

Oral assumption of two tabs/day containing Alpha-lactalbumin for 30 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centro Polispecialistico Giovanni Paolo I°

Viterbo, Rome, Italy

Site Status

Countries

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Italy

Other Identifiers

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PREBIO_LAC22

Identifier Type: -

Identifier Source: org_study_id

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