Probiotics for Treatment of Chalazion in Adults

Not Applicable

Completed

• Conditions: Chalazion
• Interventions: Other: conservative treatment; Dietary Supplement: probiotics

• Registration Number: NCT04342507
• Lead Sponsor: University of Molise

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.

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 Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2020-04
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Last Update Submitted: 2020-04-10
• Study First Posted: 2020-04-13
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: probiotics	conservative treatment	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.
Group B: probiotics	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.
Group A: conservative	conservative treatment	conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days

Primary Outcome Measures

Name	Time	Method
healing time	3 months	healing time changes with a complete resolution of chalazion

Secondary Outcome Measures

Name	Time	Method
recurrences	six months	evaluation of recurrences in both arms

Trial Locations

Locations (1)

University of Molise; 🇮🇹 Campobasso, Molise, Italy