BlepharitisNCT04742855
Probiotics for Blepharitis in Adults and Children
An observational study of Blepharitis, run by University of Molise at 1 site in Italy.
Trial summary
The alteration of the intestinal microbiota through the use of specific probiotics can improve the clinical course of blepharitis by restoring intestinal and immune homeostasis. The purpose of this study is to define the possible positive impact of probiotics on patients with blepharitis. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Blepharitis
- What is being tested?
- Probiotics
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jan 2021to 18 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients with blepharitis will be divided into three groups of 15 each (each group will be composed of 10 adults and 5 children)
Who may be able to join
- blepharitis
Who cannot join
- eyelid infection
- suspicion of malignancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Molise
Campobasso
Costagliola Ciro, 08744092269, ciro.costagliola@unimol.it
About this study
Official title: Effect of Probiotics on the Occurrence of Blepharitis in Adults and Children
The alteration of the intestinal microbiota through the use of specific probiotics can improve the clinical course of blepharitis by restoring intestinal and immune homeostasis. The purpose of this study is to define the possible positive impact of probiotics on patients with blepharitis.
Read the detailed description
From recent studies, it has emerged that the gut microbiota is a possible responsible for the stimulation of the innate immune response and its role in the pathogenesis of autoimmune diseases has been deepened. Several clinical studies, in fact, support the existence of a connection between changes in the commensal intestinal microbiota ("dysbiosis") and autoimmune diseases. It has been seen that also ocular conditions like chalaziosis and uveitis are tied to dysbiosis. In addition, in a recent study probiotics were found to be safe and effective in the treatment of chalaziosis in children. Other eye conditions that may be affected by changes in the gut microbiome are dry eye syndrome and blepharitis. Under these conditions, a reduction in globet cells has often been noted. These cells produce the mucins present on the ocular surface, and therefore, their reduction involves the production of a thin and ineffective tear film. Therefore, the study will cover patients with blepharitis (both adults and children), treated with specific probiotics to be taken daily. Patients will then undergo a full ophthalmological examination each week for the first month, and then monthly until complete recovery for at least 6 months. In addition, at the time of enlistment and complete recovery, after venous sampling, the following biomarkers will be analyzed with cytometer and ELISA: TNFα and lymphocyte subpopulations. With this study, therefore, the aim is to define the possible positive impact of probiotics on patients with blepharitis.
- Conditions
- Blepharitis
- Being tested
- Probiotics
- Keywords
- microbiome/microbiota, probiotics
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Study product is packaged as powders in a sachet. Participants and their parents will be instructed to dissolve the powder in water or milk, and to drink it in the morning and/or evening.
| Study group | Role | What they receive |
|---|---|---|
| Group A | It will consist of 10 adults and 5 children. They will get the yogurt strains Receives: Dietary Supplement: Probiotics | |
| Group B | It will consist of 10 adults and 5 children. They will get the Bifidobacterium strains. Receives: Dietary Supplement: Probiotics | |
| Group C | It will consist of 10 adults and 5 children. They will get the placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blepharitis recurrence
assessment of the number of recurrences during the time frame of the study
Measured: six months
Blepharitis resolution time
assessment of the number of days required for full resolution of the blepharitis
Measured: six months
Secondary outcomes (2)
systemic inflammatory profile
After venous sampling, the following biomarker will be analysed with a cytometer: TNFα (pg/mL) .
Measured: six months
systemic inflammatory profile
After venous sampling, the following biomarker will be analysed with a cytometer: lymphocyte subpopulations (cells/mcL).
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start18 Jan 2021
- Primary completion18 Jan 2022 (estimated)
- Study completion18 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BlepharitisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Costagliola, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742855
- Sponsor's protocol ID
- 01/2021
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu LJ, Liu J. Human Microbiota and Ophthalmic Disease. Yale J Biol Med. 2016 Sep 30;89(3):325-330. eCollection 2016 Sep.
PubMed 27698616Floyd JL, Grant MB. The Gut-Eye Axis: Lessons Learned from Murine Models. Ophthalmol Ther. 2020 Sep;9(3):499-513. doi: 10.1007/s40123-020-00278-2. Epub 2020 Jul 2.
PubMed 32617914Moon J, Yoon CH, Choi SH, Kim MK. Can Gut Microbiota Affect Dry Eye Syndrome? Int J Mol Sci. 2020 Nov 10;21(22):8443. doi: 10.3390/ijms21228443.
PubMed 33182758Filippelli M, dell'Omo R, Amoruso A, Paiano I, Pane M, Napolitano P, Bartollino S, Costagliola C. Intestinal microbiome: a new target for chalaziosis treatment in children? Eur J Pediatr. 2021 Apr;180(4):1293-1298. doi: 10.1007/s00431-020-03880-5. Epub 2020 Nov 23.
PubMed 33226501Ochoa-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 27519147Cavuoto KM, Banerjee S, Galor A. Relationship between the microbiome and ocular health. Ocul Surf. 2019 Jul;17(3):384-392. doi: 10.1016/j.jtos.2019.05.006. Epub 2019 May 21.
PubMed 31125783Moon J, Choi SH, Yoon CH, Kim MK. Gut dysbiosis is prevailing in Sjogren's syndrome and is related to dry eye severity. PLoS One. 2020 Feb 14;15(2):e0229029. doi: 10.1371/journal.pone.0229029. eCollection 2020.
PubMed 32059038
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on the Occurrence of Blepharitis in Adults and Children
- ClinicalTrials.gov ID
- NCT04742855
- Acronym / sponsor ID
- 01/2021
- Conditions
- Blepharitis
- Keywords
- microbiome/microbiota, probiotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 18 Jan 2022 (estimated)
- Study completion
- 18 Jan 2022 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The alteration of the intestinal microbiota through the use of specific probiotics can improve the clinical course of blepharitis by restoring intestinal and immune homeostasis. The purpose of this study is to define the possible positive impact of probiotics on patients with blepharitis.
Detailed description
From recent studies, it has emerged that the gut microbiota is a possible responsible for the stimulation of the innate immune response and its role in the pathogenesis of autoimmune diseases has been deepened. Several clinical studies, in fact, support the existence of a connection between changes in the commensal intestinal microbiota ("dysbiosis") and autoimmune diseases. It has been seen that also ocular conditions like chalaziosis and uveitis are tied to dysbiosis. In addition, in a recent study probiotics were found to be safe and effective in the treatment of chalaziosis in children. Other eye conditions that may be affected by changes in the gut microbiome are dry eye syndrome and blepharitis. Under these conditions, a reduction in globet cells has often been noted. These cells produce the mucins present on the ocular surface, and therefore, their reduction involves the production of a thin and ineffective tear film. Therefore, the study will cover patients with blepharitis (both adults and children), treated with specific probiotics to be taken daily. Patients will then undergo a full ophthalmological examination each week for the first month, and then monthly until complete recovery for at least 6 months. In addition, at the time of enlistment and complete recovery, after venous sampling, the following biomarkers will be analyzed with cytometer and ELISA: TNFα and lymphocyte subpopulations. With this study, therefore, the aim is to define the possible positive impact of probiotics on patients with blepharitis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Dietary Supplement: ProbioticsIt will consist of 10 adults and 5 children. They will get the yogurt strains |
| Group B | – | Dietary Supplement: ProbioticsIt will consist of 10 adults and 5 children. They will get the Bifidobacterium strains. |
| Group C | – | –It will consist of 10 adults and 5 children. They will get the placebo. |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with blepharitis will be divided into three groups of 15 each (each group will be composed of 10 adults and 5 children)
Key inclusion criteria (1 listed)
- blepharitis
Key exclusion criteria (2 listed)
- eyelid infection
- 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 |
|---|---|---|
| ProbioticsStudy product is packaged as powders in a sachet. Participants and their parents will be instructed to dissolve the powder in water or milk, and to drink it in the morning and/or evening. | Dietary supplement | Group A, Group B |
Primary outcome
Blepharitis recurrence
Time frame: six months
assessment of the number of recurrences during the time frame of the study
Blepharitis resolution time
Time frame: six months
assessment of the number of days required for full resolution of the blepharitis
2 secondary outcomes
systemic inflammatory profile
Time frame: six months
systemic inflammatory profile
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Results publication: PubMed 27698616Lu LJ, Liu J. Human Microbiota and Ophthalmic Disease. Yale J Biol Med. 2016 Sep 30;89(3):325-330. eCollection 2016 Sep.
- Results publication: PubMed 32617914Floyd JL, Grant MB. The Gut-Eye Axis: Lessons Learned from Murine Models. Ophthalmol Ther. 2020 Sep;9(3):499-513. doi: 10.1007/s40123-020-00278-2. Epub 2020 Jul 2.
- Results publication: PubMed 33182758Moon J, Yoon CH, Choi SH, Kim MK. Can Gut Microbiota Affect Dry Eye Syndrome? Int J Mol Sci. 2020 Nov 10;21(22):8443. doi: 10.3390/ijms21228443.
- Results publication: PubMed 33226501Filippelli M, dell'Omo R, Amoruso A, Paiano I, Pane M, Napolitano P, Bartollino S, Costagliola C. Intestinal microbiome: a new target for chalaziosis treatment in children? Eur J Pediatr. 2021 Apr;180(4):1293-1298. doi: 10.1007/s00431-020-03880-5. Epub 2020 Nov 23.
- Results publication: 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.
- Results publication: PubMed 31125783Cavuoto KM, Banerjee S, Galor A. Relationship between the microbiome and ocular health. Ocul Surf. 2019 Jul;17(3):384-392. doi: 10.1016/j.jtos.2019.05.006. Epub 2019 May 21.
- Results publication: PubMed 32059038Moon J, Choi SH, Yoon CH, Kim MK. Gut dysbiosis is prevailing in Sjogren's syndrome and is related to dry eye severity. PLoS One. 2020 Feb 14;15(2):e0229029. doi: 10.1371/journal.pone.0229029. eCollection 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharitis, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blepharitis recurrence (time frame: six 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 NCT04742855, which also lists 7 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 8 Feb 2021.