The Effect of Alpha-lactalbumin on Microbiota Composition

• Sponsor: Lo.Li.Pharma s.r.l (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05674318
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 5.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alpha-lactalbumin; Microbiota; Dysbiosis	Dietary Supplement: Alpha-lactalbumin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition
• Actual Study Start Date: Jan 30, 2023
• Anticipated Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Improvement of microbiota composition [Change from baseline microbiota composition to 30 days of treatment]

   Determination of bacterial biodiversity by metagenomics approach

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Polispecialistico Giovanni Paolo I°	Viterbo	Rome	Italy	01100

Sponsors and Collaborators

• Lo.Li.Pharma s.r.l

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lo.Li.Pharma s.r.l
• ClinicalTrials.gov Identifier: NCT05674318
• Other Study ID Numbers: PREBIO_LAC22
• First Posted: Jan 6, 2023
• Last Update Posted: Feb 2, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dysbiosis

Study Results

No Results Posted as of Feb 2, 2023