| CTRI Number |
CTRI/2019/07/020245 [Registered on: 18/07/2019] Trial Registered Prospectively |
| Last Modified On: |
20/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Probiotic Treatment for Uveitis |
|
Scientific Title of Study
|
Efficacy of Probiotic Therapy on Disease Outcomes in HLA-B27 Associated Anterior Uveitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sisinthy Shivaji |
| Designation |
Director BHERC |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Jhaveri Microbiology Centre
KAR Campus
LV Prasad Eye Institute
LV Prasad Marg
Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500 034
India |
| Phone |
04030612534 |
| Fax |
|
| Email |
shivas@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sisinthy Shivaji |
| Designation |
Director BHERC |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Jhaveri Microbiology Centre
KAR Campus
LV Prasad Eye Institute
LV Prasad Marg
Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500 034
India |
| Phone |
04030612534 |
| Fax |
|
| Email |
shivas@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sisinthy Shivaji |
| Designation |
Director BHERC |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Jhaveri Microbiology Centre
KAR Campus
LV Prasad Eye Institute
LV Prasad Marg
Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500 034
India |
| Phone |
04030612534 |
| Fax |
|
| Email |
shivas@lvpei.org |
|
|
Source of Monetary or Material Support
|
| Hyderabad Eye Research Foundation, L V Prasad Eye Institute, Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills, Hyderabad - 500034 |
|
|
Primary Sponsor
|
| Name |
Hyderabad Eye Research Foundation |
| Address |
LV Prasad Eye Institute
LV Prasad Marg
Banjara Hills
Hyderabad 500 034 India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sisinthy Shivaji |
LV Prasad Eye Institute |
Prof. Brian Holden Eye Research Centre, KAR Campus
LV Prasad Marg
Banjara Hills
Hyderabad 500 034 India
Hyderabad
TELANGANA |
04030612534
shivas@lvpei.org |
| Dr Soumyava Basu |
LV Prasad Eye Institute |
Uveitis Department, Mithu Tulsi Chanrai Campus
LV Prasad Eye Institute
Patia Bhubaneswar 751 024 India
Khordha
ORISSA |
06743987183
basu@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - L V Prasad Eye Institute, KAR Campus, Hyderabad |
Approved |
| Institutional Ethics Committee - L V Prasad Eye Institute, MTC Campus, Bhubaneshwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H15-H22||Disorders of sclera, cornea, iris and ciliary body, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Regular drugs |
Topical corticosteroid Prednisolone acetate 1% eye drops q2hourly for the first one week and then tapered over the next 6 weeks by one drop less every week) and cycloplegic therapy with atropine sulphate 1% eye drops or Homatropine sulphate 1% eye drops three times a day for three weeks and then as per the requirement till 8 weeks or till resolution of Uveitis. |
| Intervention |
Regular drugs plus probiotic therapy |
Topical corticosteroid Prednisolone acetate 1% eye drops q2hourly for the first one week and then tapered over the next 6 weeks by one drop less every week) and cycloplegic therapy with atropine sulphate 1% eye drops or Homatropine sulphate 1% eye drops three times a day for three weeks and then as per the requirement and probiotic one dose before lunch and dinner till 8 weeks or till resolution of Uveitis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Ability to give informed consent for participation.
2. Males or females greater than or equal to 18 years of age.
3. Patients and controls should not have received antibiotics, pro- or prebiotic treatment for at least three months prior to sample collection.
4. Patients with Non-granulomatous anterior uveitis.
5. Presenting AC reaction greater than or equal to grade 2.
6. Onset less than or equal to 2 weeks.
7. HLA-B27 positive
8. All cohorts are matched for diet, age, gender, ethnicity etc.
9. Rule out infectious etiology
|
|
| ExclusionCriteria |
| Details |
1. Posterior segment inflammation more than spillover vitritis.
2. Active infectious uveitis
3. Lens induced uveitis
4. Non-HLA-B27 associated uveitis
5. Any significant systemic or ocular disease that could compromise the uveitis in the study eye. These include, but are not limited to:
a. Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or non-proliferative diabetic retinopathy (NPDR).
b. Wet age-related macular degeneration.
c. Myopic degeneration with active sub-foveal choroidal neovascularization.
d. Uncontrolled glaucoma, intraocular pressure of > 21 mm Hg while on medical therapy, or chronic hypotony (<6 mm Hg).
6. Any implantable corticosteroid-eluting device (e.g. Ozurdex, I-vation, triamcinolone acetonide [TA] intravitreal implant) in the study eye within the past 90 days.
7. Any of the following treatments within 90 days prior to enrollments:
a. Intravitreal injections (including steroids and anti-vascular endothelial growth factors);
b. Posterior subtenon steroids.
8. Free from antibiotic and systemic immunosuppressant use (three months prior to presentation and during the course of study). |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. To demonstrate that concurrent probiotic therapy during standard treatment for HLA-B27 associated AU facilitates faster remission of clinical inflammation.
b. To demonstrate that probiotic therapy helps in prevention of relapse in patients with quiescent HLA-B27 associated AU. |
1 Week, 4 Weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor pro-inflammatory cytokines in serum of patients prior to and after probiotic therapy |
1 Week, 4 Weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Uveitis or intraocular inflammation is
the fifth most common cause of blindness and the association of Anterior Uveitis (AU)
with a Human Leucocyte Antigen (HLA) allele, called HLA-B27 is the most
frequent etiology.
Typically, it presents as recurrent attacks of acute, unilateral,
non-granulomatous AU, that is treated with corticosteroid and cycloplegic eye drops. The exact mechanism by which HLA-B27
antigen predisposes to inflammation is not clear. However, recent research has implicated the gut microbiome in the development of HLA-B27 associated AU. In addition, our earlier work on the gut
microbiome in uveitis patients (autoimmune and idiopathic), revealed that
compared to healthy controls, uveitis patients have reduced diversity and
abundance of anti-inflammatory, probiotic and antibacterial organisms in the
gut. Together, this highlights the potential of manipulating the microbiome to
alter the frequency and intensity of the disease.
The proposed study aims to evaluate
the efficacy of probiotic therapy in modifying disease outcomes in HLA-B27
anterior uveitis. The study drug “Provinorm†(UNIQUEBIOTECH,
Hyderabad, India) is a commercially available probiotic that contains a combination
of Lactobacillus acidophilus (2
billion cfu), L. rhamnosus (2 billion
cfu), L. plantarum (1. 0 billion
cfu), L. caseii (1 billion cfu), L. reuteri (2 billion cfu), L. fermentum (2 billion cfu), Bifidobacteriumbifdum (1 billion cfu)
and fructo-oligosaccharides (100 mg). Provinorm was observed to be effective in minimizing
the vaginal infections and consequent symptoms in patients with
Bacterial Vaginosis. In the present study, the intake of probiotic is
expected to fasten the remission of clinical inflammation of AU, decrease the
number of relapses and also reduce the secretion of pro-inflammatory cytokines. |