Probiotics for Treatment of Chalazion in Adults

April 10, 2020 updated by: Ciro Costagliola, University of Molise

Effects of Probiotic Oral Supplementation on the Treatment of Chalazion in Adults: a Pilot Study on 20 Patients

There is growing evidence encouraging probiotics use in several diseases. The aim of the investigator's study is to define the possible beneficial impact of probiotics on adults suffering from chalazia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective comparative pilot study on 20 adults suffering from chalazion randomly divided into two groups. The first group, received conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days. The second group, in addition to the conservative treatment, received a mixture of probiotic microorganisms once a day up to 3 months. Chalazia were classified according to their size into three groups: small (≤2 mm), medium (2-4 mm), or large (>4 mm). When conservative treatment (with and without probiotics supplementation) failed to resolve the lesion, invasive methods were used, (intralesion steroid injection in medium size chalazion and surgical incision and curettage for the largest ones).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Molise
      • Campobasso, Molise, Italy, 86100
        • University of Molise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months
  • clinical appearance and location of the lesion

Exclusion Criteria:

  • eyelid infection
  • chalazion duration < 1 month
  • nonpalpable chalazion
  • suspicion of malignancy
  • comorbidities (constitutional atopy and seborrheic dermatitis, hormonal dysfunction, presence of irritable bowel disease, infectious mainly related to Staphylococcus aureus and Propionibacterium acnes, demodex mite infestation, vitamin A deficiency, arterial hypertension, diabetes and pregnancy)
  • personal habits (smoking, eating disorders, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A: conservative
conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Other: conservative treatment
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.
Experimental: Group B: probiotics
in addition to the conservative treatment they receive probiotics mixture (Streptococcus thermophilus, Lactococcus lactis, Lactobacillus delbrueckii subsp. bulgaricus) once a day up to 3 months.
Other: conservative treatment
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.
Dietary supplement: probiotics
use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of adults chalazia by re-establishing intestinal and immune homeostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing time
Time Frame: 3 months
healing time changes with a complete resolution of chalazion
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrences
Time Frame: six months
evaluation of recurrences in both arms
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Molise

Investigators

  • Principal Investigator: Ciro Costagliola, Full Professor, University of Molise

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe