NCT05674318

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 20, 2024

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

December 21, 2022

Last Update Submit

February 19, 2024

Conditions

Alpha-lactalbuminMicrobiotaDysbiosis

Outcome Measures

Primary Outcomes (1)

  • Improvement of microbiota composition

    Determination of bacterial biodiversity by metagenomics approach

    Change from baseline microbiota composition to 30 days of treatment

Study Arms (1)

Alpha-lactalbumin

EXPERIMENTAL
Dietary Supplement: Alpha-lactalbumin

Interventions

Alpha-lactalbuminDIETARY_SUPPLEMENT

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

Alpha-lactalbumin

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • condition of dysbiosis

You may not qualify if:

  • antibiotic treatment within 1 month
  • probiotic or prebiotic treatments
  • concomitant inflammatory intestinal diseases
  • pregnancy
  • neoplastic diseases
  • allergy to milk protein (Alpha-lactalbumin)
  • substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Polispecialistico Giovanni Paolo I°

Viterbo, Rome, 01100, Italy

Location

MeSH Terms

Conditions

Dysbiosis

Interventions

Lactalbumin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlbuminsProteinsAmino Acids, Peptides, and ProteinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 6, 2023

Study Start

January 30, 2023

Primary Completion

September 30, 2023

Study Completion

November 30, 2023

Last Updated

February 20, 2024

Record last verified: 2023-06

Locations

IT(1)