ChalazionNCT04322500
Probiotics for Chalaziosis Treatment in Children
A study testing probiotics and conservative treatment in people with Chalazion, run by University of Molise at 1 site in Italy.
Trial summary
There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Chalazion
- What is being tested?
- probiotics and conservative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- paediatric patients
- presence of one or more eyelid mass lesions (history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months)
Who cannot join
- eyelid infection
- chalazion duration < 1 month
- nonpalpable chalazion
- suspicion of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children
There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis.
Read the detailed description
Prospective comparative pilot study on 26 children suffering from chalaziosis. They will be randomly divided in two groups. One group will receive conservative treatment and the other one will receive conservative treatment and a daily supplementation of probiotics. All patients will be evaluated at 2-week intervals for 3 months. If the lesion will not disappear or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will be repeated for another 3-months cycle. The follow up periods extend from 3 to 6 months according to the results.
- Conditions
- Chalazion
- Being tested
- probiotics, conservative treatment
- Keywords
- microbiome/microbiota, probiotics, chalaziosis, children
- Medical subject headings
- Chalazion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis
conservative treatmentOther
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
| Study group | Role | What they receive |
|---|---|---|
| Group A: conservative | Other | conservative treatment Receives: Other: conservative treatment |
| Group B: probiotics | Experimental | in addition to the conservative treatment they receive a probiotics mixture (Streptococcus thermophilus ST10, Lactococcus lactis LLCO2 and Lactobacillus delbrueckii subsp. bulgaricus LDB01) Receives: Dietary Supplement: probiotics; Other: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Taken for a Complete Resolution of the Chalaziosis
change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Measured: 3 months
Number of Recurrences
complete ophthalmological evaluation was done weekly during the first month and then monthly in order to evaluate possible recurrences (presence of a new eyelid mass lesion)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Feb 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ChalazionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective comparative pilot study with two groups randomly divided
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Costagliola, University of Molise
- Investigators
- Ciro Costagliola, Full Professor, Principal investigator, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322500
- Sponsor's protocol ID
- 07/2019
- Status last verified
- Apr 2020
- First submitted
- 23 Mar 2020
- Last updated
- 5 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kerry RG, Patra JK, Gouda S, Park Y, Shin HS, Das G. Benefaction of probiotics for human health: A review. J Food Drug Anal. 2018 Jul;26(3):927-939. doi: 10.1016/j.jfda.2018.01.002. Epub 2018 Feb 2.
PubMed 29976412McLean MH, Dieguez D Jr, Miller LM, Young HA. Does the microbiota play a role in the pathogenesis of autoimmune diseases? Gut. 2015 Feb;64(2):332-41. doi: 10.1136/gutjnl-2014-308514. Epub 2014 Nov 21.
PubMed 25416067Scher JU, Littman DR, Abramson SB. Microbiome in Inflammatory Arthritis and Human Rheumatic Diseases. Arthritis Rheumatol. 2016 Jan;68(1):35-45. doi: 10.1002/art.39259. No abstract available.
PubMed 26331579Ochoa-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.
PubMed 27519147Kalyana Chakravarthy S, Jayasudha R, Sai Prashanthi G, Ali MH, Sharma S, Tyagi M, Shivaji S. Dysbiosis in the Gut Bacterial Microbiome of Patients with Uveitis, an Inflammatory Disease of the Eye. Indian J Microbiol. 2018 Dec;58(4):457-469. doi: 10.1007/s12088-018-0746-9. Epub 2018 Jun 4.
PubMed 30262956Iovieno A, Lambiase A, Sacchetti M, Stampachiacchiere B, Micera A, Bonini S. Preliminary evidence of the efficacy of probiotic eye-drop treatment in patients with vernal keratoconjunctivitis. Graefes Arch Clin Exp Ophthalmol. 2008 Mar;246(3):435-41. doi: 10.1007/s00417-007-0682-6. Epub 2007 Nov 27.
PubMed 18040708Tavakoli A, Flanagan JL. The Case for a More Holistic Approach to Dry Eye Disease: Is It Time to Move beyond Antibiotics? Antibiotics (Basel). 2019 Jun 30;8(3):88. doi: 10.3390/antibiotics8030088.
PubMed 31262073Lin P. The role of the intestinal microbiome in ocular inflammatory disease. Curr Opin Ophthalmol. 2018 May;29(3):261-266. doi: 10.1097/ICU.0000000000000465.
PubMed 29538183Baim AD, Movahedan A, Farooq AV, Skondra D. The microbiome and ophthalmic disease. Exp Biol Med (Maywood). 2019 Apr;244(6):419-429. doi: 10.1177/1535370218813616. Epub 2018 Nov 21.
PubMed 30463439Kugadas A, Gadjeva M. Impact of Microbiome on Ocular Health. Ocul Surf. 2016 Jul;14(3):342-9. doi: 10.1016/j.jtos.2016.04.004. Epub 2016 May 14.
PubMed 27189865Lin P. Importance of the intestinal microbiota in ocular inflammatory diseases: A review. Clin Exp Ophthalmol. 2019 Apr;47(3):418-422. doi: 10.1111/ceo.13493. Epub 2019 Mar 25.
PubMed 30834680Sansotta N, Peroni DG, Romano S, Rugiano A, Vuilleumier P, Baviera G; Italian Society of Pediatric Allergy, Immunology (SIAIP), Microbiota Committee, Italy. The good bugs: the use of probiotics in pediatrics. Curr Opin Pediatr. 2019 Oct;31(5):661-669. doi: 10.1097/MOP.0000000000000808.
PubMed 31356353Sklar BA, Gervasio KA, Leng S, Ghosh A, Chari A, Wu AY. Management and outcomes of proteasome inhibitor associated chalazia and blepharitis: a case series. BMC Ophthalmol. 2019 May 14;19(1):110. doi: 10.1186/s12886-019-1118-x.
PubMed 31088416Malekahmadi M, Farrahi F, Tajdini A. Serum Vitamin A Levels in Patients with Chalazion. Med Hypothesis Discov Innov Ophthalmol. 2017 Fall;6(3):63-66.
PubMed 29392144Yam JC, Tang BS, Chan TM, Cheng AC. Ocular demodicidosis as a risk factor of adult recurrent chalazion. Eur J Ophthalmol. 2014 Mar-Apr;24(2):159-63. doi: 10.5301/ejo.5000341. Epub 2013 Jul 16.
PubMed 23873491
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children
- ClinicalTrials.gov ID
- NCT04322500
- Acronym / sponsor ID
- 07/2019
- Conditions
- Chalazion
- Keywords
- microbiome/microbiota, probiotics, chalaziosis, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis.
Detailed description
Prospective comparative pilot study on 26 children suffering from chalaziosis. They will be randomly divided in two groups. One group will receive conservative treatment and the other one will receive conservative treatment and a daily supplementation of probiotics. All patients will be evaluated at 2-week intervals for 3 months. If the lesion will not disappear or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will be repeated for another 3-months cycle. The follow up periods extend from 3 to 6 months according to the results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective comparative pilot study with two groups randomly divided
| Arm | Type | Receives |
|---|---|---|
| Group A: conservative | Other | Other: conservative treatmentconservative treatment |
| Group B: probiotics | Experimental | Dietary Supplement: probiotics, Other: conservative treatmentin addition to the conservative treatment they receive a probiotics mixture (Streptococcus thermophilus ST10, Lactococcus lactis LLCO2 and Lactobacillus delbrueckii subsp. bulgaricus LDB01) |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- paediatric patients
- presence of one or more eyelid mass lesions (history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months)
Key exclusion criteria (4 listed)
- eyelid infection
- chalazion duration < 1 month
- nonpalpable chalazion
- suspicion of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probioticsuse specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis | Dietary supplement | Group B: probiotics |
| conservative treatmentlid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days | Other | Group A: conservative, Group B: probiotics |
Primary outcome
Time Taken for a Complete Resolution of the Chalaziosis
Time frame: 3 months
change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Number of Recurrences
Time frame: 3 months
complete ophthalmological evaluation was done weekly during the first month and then monthly in order to evaluate possible recurrences (presence of a new eyelid mass lesion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29976412Kerry RG, Patra JK, Gouda S, Park Y, Shin HS, Das G. Benefaction of probiotics for human health: A review. J Food Drug Anal. 2018 Jul;26(3):927-939. doi: 10.1016/j.jfda.2018.01.002. Epub 2018 Feb 2.
- Background: PubMed 25416067McLean MH, Dieguez D Jr, Miller LM, Young HA. Does the microbiota play a role in the pathogenesis of autoimmune diseases? Gut. 2015 Feb;64(2):332-41. doi: 10.1136/gutjnl-2014-308514. Epub 2014 Nov 21.
- Background: PubMed 26331579Scher JU, Littman DR, Abramson SB. Microbiome in Inflammatory Arthritis and Human Rheumatic Diseases. Arthritis Rheumatol. 2016 Jan;68(1):35-45. doi: 10.1002/art.39259. No abstract available.
- Background: PubMed 27519147Ochoa-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.
- Background: PubMed 30262956Kalyana Chakravarthy S, Jayasudha R, Sai Prashanthi G, Ali MH, Sharma S, Tyagi M, Shivaji S. Dysbiosis in the Gut Bacterial Microbiome of Patients with Uveitis, an Inflammatory Disease of the Eye. Indian J Microbiol. 2018 Dec;58(4):457-469. doi: 10.1007/s12088-018-0746-9. Epub 2018 Jun 4.
- Background: PubMed 18040708Iovieno A, Lambiase A, Sacchetti M, Stampachiacchiere B, Micera A, Bonini S. Preliminary evidence of the efficacy of probiotic eye-drop treatment in patients with vernal keratoconjunctivitis. Graefes Arch Clin Exp Ophthalmol. 2008 Mar;246(3):435-41. doi: 10.1007/s00417-007-0682-6. Epub 2007 Nov 27.
- Background: PubMed 31262073Tavakoli A, Flanagan JL. The Case for a More Holistic Approach to Dry Eye Disease: Is It Time to Move beyond Antibiotics? Antibiotics (Basel). 2019 Jun 30;8(3):88. doi: 10.3390/antibiotics8030088.
- Background: PubMed 29538183Lin P. The role of the intestinal microbiome in ocular inflammatory disease. Curr Opin Ophthalmol. 2018 May;29(3):261-266. doi: 10.1097/ICU.0000000000000465.
- Background: PubMed 30463439Baim AD, Movahedan A, Farooq AV, Skondra D. The microbiome and ophthalmic disease. Exp Biol Med (Maywood). 2019 Apr;244(6):419-429. doi: 10.1177/1535370218813616. Epub 2018 Nov 21.
- Background: PubMed 27189865Kugadas A, Gadjeva M. Impact of Microbiome on Ocular Health. Ocul Surf. 2016 Jul;14(3):342-9. doi: 10.1016/j.jtos.2016.04.004. Epub 2016 May 14.
- Background: PubMed 30834680Lin P. Importance of the intestinal microbiota in ocular inflammatory diseases: A review. Clin Exp Ophthalmol. 2019 Apr;47(3):418-422. doi: 10.1111/ceo.13493. Epub 2019 Mar 25.
- Background: PubMed 31356353Sansotta N, Peroni DG, Romano S, Rugiano A, Vuilleumier P, Baviera G; Italian Society of Pediatric Allergy, Immunology (SIAIP), Microbiota Committee, Italy. The good bugs: the use of probiotics in pediatrics. Curr Opin Pediatr. 2019 Oct;31(5):661-669. doi: 10.1097/MOP.0000000000000808.
- probiotics definitionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciro Costagliola, Full Professor principal investigator
University of Molise
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics and conservative treatment in people with Chalazion, run by University of Molise at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Taken for a Complete Resolution of the Chalaziosis (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322500, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.