| CTRI Number |
CTRI/2024/12/077627 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study to detect H Pylori infection using breath test. |
|
Scientific Title of Study
|
An open label, non-randomized study of the PYtest ® Kit (urea[14C] breath test) for the
detection of helicobacter pylori |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 24-TMD-001, Version:01,04/06/2024 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narasimhaiah S |
| Designation |
Principal Investigator |
| Affiliation |
Apollo Hospital |
| Address |
Room No : 3, Colorectal Surgeon, Colorectal surgery (Colorectal, Peritoneal & Pelvic Oncology) - Laparoscopic & Robotic Surgery.
Opposite IIMB, Bannerghatta Road, Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
8197088434 |
| Fax |
|
| Email |
drnarasimhaiah_s@apollohospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vimla Dsouza |
| Designation |
Director - Clinical Operation |
| Affiliation |
Arcolab Private Limited |
| Address |
19/2, 15th Cross Rd, opp. K C DAS, Dollar Layout, 4th Phase, J. P. Nagar, Bengaluru.
J. P. Nagar, Bengaluru.
Bangalore
KARNATAKA
560078
India |
| Phone |
9844224041 |
| Fax |
|
| Email |
Vimla.Dsouza@arcolab.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimla Dsouza |
| Designation |
Director - Clinical Operation |
| Affiliation |
Arcolab Private Limited |
| Address |
19/2, 15th Cross Rd, opp. K C DAS, Dollar Layout, 4th Phase,
J. P. Nagar, Bengaluru.
Bangalore
KARNATAKA
560078
India |
| Phone |
9844224041 |
| Fax |
|
| Email |
Vimla.Dsouza@arcolab.com |
|
|
Source of Monetary or Material Support
|
| Tri-Med Distributors Pty Ltd,
Unit 6/15 Walters Drive,
Osborne Park, WA 6017
Australia.
|
|
|
Primary Sponsor
|
| Name |
Tri-Med Distributors Pty Ltd |
| Address |
Walters Drive
Osborne Park,WA 6017
Australia |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| Radhakrishnan |
Apollo Hospitals |
Room No : 3, Colorectal Surgeon, Colorectal surgery (Colorectal, Peritoneal & Pelvic Oncology) - Laparoscopic & Robotic Surgery, Opposite IIMB, Bannerghatta Road
Bangalore
KARNATAKA |
8056707008
radhakrishnan@apolloari.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Apollo Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PYtest® Urea [14 C] Capsule |
Urea breath test using urea[14C] capsule of the PYtest® Kit.
To detect H. pylori, urea labelled with 14C is swallowed by the patient. If gastric urease from H. pylori is
present, urea is split to form CO2 and NH3 at the interface between the gastric epithelium and lumen and
14CO2 is absorbed into the blood and exhaled in the breath.
Following ingestion of the capsule by a patient with H. pylori, 14CO2 excretion in the breath peaks between
10 and 15 minutes and declines thereafter with a biological half-life of about 15 minutes.
|
| Comparator Agent |
Rapid Urease test |
The rapid urease test is an indirect method for detecting the presence of H. pylori based on the activity of urease enzyme produced by the bacteria. This test involves endoscopic evaluation where a biopsy of the gastric mucosa will be taken. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who present with clinical symptoms of H. pylori
Have the ability and willingness to sign the Informed Consent Form |
|
| ExclusionCriteria |
| Details |
Patient with current serious underlying disease.
Participation in other trials currently.
Patients who have been taking or have taken antibiotics and/or bismuth preparations for (4) weeks prior to test. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of PYtest® (urea[14C] breath test) kit in comparison to Rapid urease diagnostic test. |
The diagnostic tests will be performed during Visit 2, which should be scheduled within 3 days of Visit 1 (Screening).
Visit 2 will include the following procedures:
• Endoscopy and Rapid Urease Test
• PYtest® (urea[14C] capsule) administration and Urea breath analysis
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of Urea[14C] capsule of PYtest ® Kit |
The safety will be evaluated during Visit 2, which should be scheduled within 3 days of Visit 1 (Screening), & at the end of the study (follow up period), that is within 3 days of the Visit 2 . |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
11/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The purpose of the study is to establish the sensitivity and specificity of the PYtest® (urea[14C] capsule) in comparison to Rapid urease diagnostic test in Indian population. To evaluate the sensitivity and specificity of PYtest® (urea[14C] breath test) kit for H. pylori in comparison to Rapid urease diagnostic test. Also to evaluate the safety of Urea[14C] capsule of PYtest ® Kit. Sensitivity, specificity, positive predictive value, and negative predictive value will be determined using a 2x2 table for comparison between breath test and reference methods. The product of positive predictive value and negative predictive value will be used to define the accuracy. One-sided 95% confidence intervals for sensitivity and specificity as well as positive and negative predictive values will be calculated using one sample binomial test. |