NCT04742855

Brief Summary

The alteration of the intestinal microbiota through the use of specific probiotics can improve the clinical course of blepharitis by restoring intestinal and immune homeostasis. The purpose of this study is to define the possible positive impact of probiotics on patients with blepharitis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 18, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 29, 2021

Last Update Submit

February 3, 2021

Conditions

Blepharitis

Keywords

microbiome/microbiotaprobiotics

Outcome Measures

Primary Outcomes (2)

  • Blepharitis recurrence

    assessment of the number of recurrences during the time frame of the study

    six months

  • Blepharitis resolution time

    assessment of the number of days required for full resolution of the blepharitis

    six months

Secondary Outcomes (2)

  • systemic inflammatory profile

    six months

  • systemic inflammatory profile

    six months

Study Arms (3)

Group A

It will consist of 10 adults and 5 children. They will get the yogurt strains

Dietary Supplement: Probiotics

Group B

It will consist of 10 adults and 5 children. They will get the Bifidobacterium strains.

Dietary Supplement: Probiotics

Group C

It will consist of 10 adults and 5 children. They will get the placebo.

Interventions

ProbioticsDIETARY_SUPPLEMENT

Study product is packaged as powders in a sachet. Participants and their parents will be instructed to dissolve the powder in water or milk, and to drink it in the morning and/or evening.

Group AGroup B

Eligibility Criteria

Age8 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients with blepharitis will be divided into three groups of 15 each (each group will be composed of 10 adults and 5 children)

You may qualify if:

  • blepharitis

You may not qualify if:

  • eyelid infection
  • suspicion of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Molise

Campobasso, Italy

RECRUITING

Related Publications (7)

  • Lu LJ, Liu J. Human Microbiota and Ophthalmic Disease. Yale J Biol Med. 2016 Sep 30;89(3):325-330. eCollection 2016 Sep.

    PMID: 27698616RESULT

  • Floyd JL, Grant MB. The Gut-Eye Axis: Lessons Learned from Murine Models. Ophthalmol Ther. 2020 Sep;9(3):499-513. doi: 10.1007/s40123-020-00278-2. Epub 2020 Jul 2.

    PMID: 32617914RESULT

  • Moon J, Yoon CH, Choi SH, Kim MK. Can Gut Microbiota Affect Dry Eye Syndrome? Int J Mol Sci. 2020 Nov 10;21(22):8443. doi: 10.3390/ijms21228443.

    PMID: 33182758RESULT

  • Filippelli M, dell'Omo R, Amoruso A, Paiano I, Pane M, Napolitano P, Bartollino S, Costagliola C. Intestinal microbiome: a new target for chalaziosis treatment in children? Eur J Pediatr. 2021 Apr;180(4):1293-1298. doi: 10.1007/s00431-020-03880-5. Epub 2020 Nov 23.

    PMID: 33226501RESULT

  • Ochoa-Reparaz J, Kasper LH. The influence of gut-derived CD39 regulatory T cells in CNS demyelinating disease. Transl Res. 2017 Jan;179:126-138. doi: 10.1016/j.trsl.2016.07.016. Epub 2016 Jul 28.

    PMID: 27519147RESULT

  • Cavuoto KM, Banerjee S, Galor A. Relationship between the microbiome and ocular health. Ocul Surf. 2019 Jul;17(3):384-392. doi: 10.1016/j.jtos.2019.05.006. Epub 2019 May 21.

    PMID: 31125783RESULT

  • Moon J, Choi SH, Yoon CH, Kim MK. Gut dysbiosis is prevailing in Sjogren's syndrome and is related to dry eye severity. PLoS One. 2020 Feb 14;15(2):e0229029. doi: 10.1371/journal.pone.0229029. eCollection 2020.

    PMID: 32059038RESULT

MeSH Terms

Conditions

Blepharitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor in Ophthalmology

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 8, 2021

Study Start

January 18, 2021

Primary Completion

January 18, 2022

Study Completion

January 18, 2022

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

IT(1)