Probiotics for Treatment of Chalazion in Adults

Sponsor

University of Molise (Other)

Overall Status

Completed

CT.gov ID

NCT04342507

Collaborator

(none)

Enrollment

Location

Arms

12.9

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chalazion	Other: conservative treatment Dietary Supplement: probiotics	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective comparative pilot study with two groups randomly dividedProspective comparative pilot study with two groups randomly divided

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Feb 29, 2020

Actual Study Completion Date :

Feb 29, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

healing time [3 months]
healing time changes with a complete resolution of chalazion

Secondary Outcome Measures

recurrences [six months]
evaluation of recurrences in both arms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Molise	Campobasso	Molise	Italy	86100

Sponsors and Collaborators

University of Molise

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Ciro Costagliola, Full Professor in Ophthalmology, University of Molise

ClinicalTrials.gov Identifier:

NCT04342507

Other Study ID Numbers:

08/2019

First Posted:

Apr 13, 2020

Last Update Posted:

Apr 14, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ciro Costagliola, Full Professor in Ophthalmology, University of Molise

microbiome/microbiota

probiotics

adults

Additional relevant MeSH terms:

Chalazion

Study Results

No Results Posted as of Apr 14, 2020