The Effect of Alpha-lactalbumin on Microbiota Composition

Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05674318

Enrollment

Registered

2023-01-06

Start date

2023-01-30

Completion date

2023-11-30

Last updated

2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alpha-lactalbumin, Microbiota, Dysbiosis

Brief summary

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

Interventions

DIETARY_SUPPLEMENTAlpha-lactalbumin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 50 Years

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

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026