Back to resultsProbiotics for Treatment of Chalazion in Adults
Primary Purpose
Chalazion
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
conservative treatment
probiotics
Sponsored by
About this trial
This is an interventional supportive care trial for Chalazion focused on measuring microbiome/microbiota, probiotics, adults
Eligibility Criteria
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.)
Sites / Locations
- University of Molise
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Group A: conservative
Group B: probiotics
Arm Description
conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
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.
Outcomes
Primary Outcome Measures
healing time
healing time changes with a complete resolution of chalazion
Secondary Outcome Measures
recurrences
evaluation of recurrences in both arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04342507
Brief Title
Probiotics for Treatment of Chalazion in Adults
Official Title
Effects of Probiotic Oral Supplementation on the Treatment of Chalazion in Adults: a Pilot Study on 20 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Molise
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion
Keywords
microbiome/microbiota, probiotics, adults
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective comparative pilot study with two groups randomly divided
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: conservative
Arm Type
Other
Arm Description
conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Arm Title
Group B: probiotics
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
conservative treatment
Intervention Description
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
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
Primary Outcome Measure Information:
Title
healing time
Description
healing time changes with a complete resolution of chalazion
Time Frame
3 months
Secondary Outcome Measure Information:
Title
recurrences
Description
evaluation of recurrences in both arms
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ciro Costagliola, Full Professor
Organizational Affiliation
University of Molise
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Molise
City
Campobasso
State/Province
Molise
ZIP/Postal Code
86100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://journals.prous.com/journals/servlet/xmlxsl/pk_journals.xml_summary_pr?p_JournalId=4&p_RefId=3079409&p_IsPs=N
Description
MicroRNAs and microbiota: Is there a cross talk?
URL
https://academic.oup.com/cid/article/32/11/1567/462037
Description
Probiotic Agents and Infectious Diseases: A Modern Perspective on a Traditional Therapy
Learn more about this trial
Probiotics for Treatment of Chalazion in Adults
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