| CTRI Number |
CTRI/2024/02/062346 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To study Small Intestinal Bacterial Overgrowth in patients with Functional Dyspepsia: A case-control study |
|
Scientific Title of Study
|
Evaluation of Small Intestinal Bacterial Overgrowth in patients with Functional Dyspepsia: A case-control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RAHUL CH |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Govind Ballabh Pant Institute of Post Graduate Medical Education and Research |
| Address |
Academic block, Second floor, Department of Gastroenterology, Govind Ballabh Pant Institute of Post Graduate Medical Education and Research, Jawaharlal Nehru Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9013026865 |
| Fax |
|
| Email |
chrahul0895@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJEEV SACHDEVA |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
Govind Ballabh Pant Institute of Post Graduate Medical Education and Research |
| Address |
Academic block, Second floor, Department of Gastroenterology, Govind Ballabh Pant Institute of Post Graduate Medical Education and Research, Jawaharlal Nehru Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9718599204 |
| Fax |
|
| Email |
sanjeevgastro@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAHUL CH |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Govind Ballabh Pant Institute of Post Graduate Medical Education and Research |
| Address |
Academic block, Second floor, Department of Gastroenterology, Govind Ballabh Pant Institute of Post Graduate Medical Education and Research, Jawaharlal Nehru Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9013026865 |
| Fax |
|
| Email |
chrahul0895@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govind Ballabh Pant Institute of Post Graduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Govind Ballabh Pant Institute of Post Graduate Medical Education and Research |
| Address |
Jawaharlal Nehru Marg, New Delhi 110002 |
| Type of Sponsor |
Government 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 |
| DR RAHUL CH |
Govind Ballabh Pant Institute of Post Graduate Medical Education and Research |
Department of Gastroenterology, Academic block, Second floor, New Delhi
Central
DELHI |
9013026865
chrahul0895@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hosptal Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
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 |
Patients in between ages of 18-60 years, diagnosed as Functional Dyspepsia according to ROME IV Criteria will be considered as Cases and Healthy individuals in between ages of 18-60 years will be considered as Controls |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation, HIV patients, Prior gastric surgery, Patients on prokinetics, patients on lactulose within one month, other hepatobiliary diseases, abnormal endoscopy findings, systemic sclerosis, hypothyroidism, intestinal pseudo-obstuction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of Small Intestinal Bacterial overgrowth among patients with Functional dyspepsia as compared to healthy controls |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictors of Small Intestinal Bacterial overgrowth among patients with Functional Dyspepsia |
At the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2024 |
| 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)
|
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
|
Ours is a case-control study being conducted at a tertiary center. Patients include people with a diagnosis of Functional dyspepsia and controls are healthy individuals. The cases undergo a Glucose Hydrogen Breath test (GHBT) to evaluate for Small Intestinal bacterial overgrowth. Also, patients undergo a few baseline blood investigations. Controls undergo only a Glucose Hydrogen Breath test to evaluate for Small Intestinal Bacterial Overgrowth. The frequency of Small intestinal bacterial overgrowth in cases and Controls will be compared. Predictors of Small intestinal bacterial overgrowth in patients will be evaluated. |