| CTRI Number |
CTRI/2026/03/105605 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Detecting Stomach Infection (H. pylori) Using a Smart Breath Test. |
|
Scientific Title of Study
|
A Smart Breath Analysis System for Non-Invasive Detection of Urease Activity in Helicobacter pylori Patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GUNDETI THARUN REDDY |
| Designation |
Post graduate, General medicine |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of general medicine, Saveetha medical college and hospital, saveetha nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9890901617 |
| Fax |
|
| Email |
Tarunreddy3635@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MARIRAJ I |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of general medicine, Saveetha medical college and hospital, saveetha nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7299376822 |
| Fax |
|
| Email |
justmariraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GUNDETI THARUN REDDY |
| Designation |
Post graduate general medicine |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of general medicine, Saveetha medical college and hospital, saveetha nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9890901617 |
| Fax |
|
| Email |
Tarunreddy3635@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Gundeti Tharun Reddy |
Saveetha medical college and hospital |
Department of general medicine, Saveetha nagar, Thandalam, Chennai- 602105, TAMIL NADU Chennai TAMIL NADU
Kancheepuram
TAMIL NADU |
9890901617
Tarunreddy3635@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals aged 18 years and above.
2)Patients presenting with gastrointestinal symptoms suggestive of Helicobacter pylori infection (e.g., upper abdominal pain, bloating, nausea).
3)Patients who are willing and able to provide informed consent.
4)Participants willing to undergo both the smart breath analyzer test and standard diagnostic procedures for H. pylori.
|
|
| ExclusionCriteria |
| Details |
1)Patients who have taken antibiotics, proton pump inhibitors (PPIs), or bismuth compounds within the last 4 weeks.
2)History of gastrectomy or major gastrointestinal surgery.
3)Pregnant or breastfeeding women.
4)Patients with severe respiratory conditions (e.g., COPD) that may interfere with breath sampling.
5)Individuals with known allergies to the urea test substrate.
6)Patients unable to comply with study procedures or follow-up.
7)Cognitively impaired individuals unable to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To develop and evaluate a novel smart breath analyzer capable of accurately detecting Helicobacter pylori infection by measuring urease activity in exhaled breath, offering a non-invasive, rapid, and user-friendly diagnostic alternative to conventional methods.
|
Day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of the smart breath analyzer with the standard urea breath test and/or endoscopic biopsy-based methods.
To assess the usability and patient compliance associated with the smart breath analyzer in clinical and outpatient settings.
To evaluate the real-time data processing and interpretation capabilities of the device’s integrated smart interface.
|
Day 0, day 2 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/03/2026 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This research evaluates a novel smart breath analyzer designed to detect Helicobacter pylori infection by measuring urease activity in exhaled breath. The study will be conducted at Saveetha Medical College on 30 adults with gastrointestinal symptoms suggestive of H. pylori. Participants will perform the breath test after ingesting a urea solution, and results will be compared with standard diagnostic methods. The main objective is to determine the diagnostic accuracy (sensitivity and specificity) of the device. The study also assesses patient comfort, usability, and time to obtain results. If successful, the device could provide a rapid, non-invasive, and cost-effective alternative for diagnosing H. pylori.
|