The Effect of Alpha-lactalbumin on Microbiota Composition

Not Applicable

Completed

• Conditions: Alpha-lactalbumin; Microbiota; Dysbiosis
• Interventions: Dietary Supplement: Alpha-lactalbumin

• Registration Number: NCT05674318
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-06
• Study Start: 2023-01-30
• Status Verified: 2023-06
• Primary Completion: 2023-09-30
• Study Completion: 2023-11-30
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alpha-lactalbumin	Alpha-lactalbumin	-

Primary Outcome Measures

Name	Time	Method
Improvement of microbiota composition	Change from baseline microbiota composition to 30 days of treatment	Determination of bacterial biodiversity by metagenomics approach

Trial Locations

Locations (1)

Centro Polispecialistico Giovanni Paolo I°; 🇮🇹 Viterbo, Rome, Italy