| CTRI Number |
CTRI/2025/11/098238 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess alterations in the fungal gut microbiome of patients with chronic spontaneous urticaria and comparing it with healthy controls |
|
Scientific Title of Study
|
A comparative study to assess the fungal gut microbiome alterations in patients with chronic spontaneous urticaria and controls |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Haritha Prasanth |
| Designation |
Junior Resident |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Dermatology,
Amala Institute of Medical Sciences, Amala nagar,Thrissur
Kerala
Thrissur
KERALA
680555
India |
| Phone |
9496489136 |
| Fax |
|
| Email |
harithaprasanth254@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sebastian Criton |
| Designation |
Professor and HOD |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Dermatology,
Amala Institute of Medical Sciences, Amala nagar,Thrissur
Kerala
Thrissur
KERALA
680555
India |
| Phone |
9447009990 |
| Fax |
|
| Email |
criton@thecriton.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sebastian Criton |
| Designation |
Professor and HOD |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Dermatology,
Amala Institute of Medical Sciences, Amala nagar,Thrissur
Kerala
Thrissur
KERALA
680555
India |
| Phone |
9447009990 |
| Fax |
|
| Email |
criton@thecriton.com |
|
|
Source of Monetary or Material Support
|
| Applied for IADVL project grant,if not approved will be self funded |
|
|
Primary Sponsor
|
| Name |
Haritha Prasanth |
| Address |
Junior Resident
Amala Institute of Medical Sciences, Amala nagar, Thrissur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Haritha Prasanth |
Amala Institute of Medical Sciences |
Department of Dermatology,
Amala Institute of Medical Sciences, Amala nagar,Thrissur
Kerala
Thrissur
KERALA |
9496489136
harithaprasanth254@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Amala Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L508||Other urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
CASES- 1. Clinically diagnosed patients with chronic spontaneous urticaria
CONTROLS-1. Healthy individuals volunteering to participate in the study
|
|
| ExclusionCriteria |
| Details |
CASES- 1. Patients exposed to treatment with antifungals and proton pump inhibitors one month before sample collection
2. Patients with active fever or gastrointestinal infections
3. Patients with history of GI surgeries
4. Patients with immunodeficiency disorders, auto-inflammatory syndromes, urticarial vasculitis, severe infections
5. Patients treated with systemic corticosteroids, immunomodulators 1 month before sample collection
CONTROLS- 1. Individuals with personal history of urticaria, atopic dermatitis, allergic rhinitis, conjunctivitis, asthma, anaphylaxis
2. Individuals with other dermatological diseases, GI infection or history of GI surgeries, those diagnosed with irritable bowel syndrome, inflammatory bowel disease and any other autoimmune diseases
3. Use of systemic antifungals, proton pump inhibitors, systemic steroids, immunomodulators one month before sample collection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fungal gut microbiome in patients with chronic spontaneous urticaria and healthy controls |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
01/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a cross sectional study to assess the fungal gut gut microbiome alterations in chronic spontaneous urticaria compared to healthy controls. All clinically diagnosed cases of chronic spontaneous urticaria attending OPD and healthy controls satisfying the inclusion and exclusion criteria will be selected for the study. All participants will be subjected to detail history taking and a written informed consent will be obtained. Participants will provide stool samples which will be collected in sterile containers and stored at -80 degree celsius until processing. Total DNA will be extracted from the stool samples using a commercially available kit. The DNA samples will be then amplified, sequenced and analysed using ITS gene sequencing. This will allow us to determine fungal gut microbiome. This study focuses on fungal gut microbiome alterations in patients with chronic spontaneous urticaria and thus providing a promising therapeutic option in future, thereby improving the quality of life in patients with chronic spontaneous urticaria. |