Weight Loss Clinical Trial
Official title:
Helicobacter Pylori Sample Collection Protocol PRE-THERAPY
Verified date | February 2019 |
Source | DiaSorin Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.
Status | Completed |
Enrollment | 277 |
Est. completion date | May 3, 2018 |
Est. primary completion date | May 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - Adult = 22 years, either gender - Subject is symptomatic showing signs and symptoms of gastritis - Subject is not under evaluation for post-therapy follow up diagnosis - Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing - Biopsy is obtained from antrum and/or corpus and is tested by CRM - At least two of the three CRM tests are performed - Subject whose EGD with biopsy procedure occurred = 7 days prior to stool collection - Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B Exclusion Criteria: - Any subject that does not meet the inclusion criteria - Subject with current severe H. pylori infection - Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection - Subject recently tested, less than 3 months and knowledge of H. pylori absence - Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment - Pregnant or lactating - Inability or unwilling to perform required study procedures - Subject is unable or unwilling to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Italy | One (1) Location in Bologna, Italy | Bologna | |
United States | One (1) Location in North Carolina | Asheville | North Carolina |
United States | One (1) Location in Virginia | Chesapeake | Virginia |
United States | One (1) Location in Great Neck, New York | Great Neck | New York |
United States | One (1) Location in Greenville, South Carolina | Greenville | South Carolina |
United States | One (1) Location in Houston, Texas | Houston | Texas |
United States | One (1) Location in Ohio | Mentor | Ohio |
United States | One (1) Location in Arizonia | Mesa | Arizona |
United States | One (1) Location in Mission Hills, California | Mission Hills | California |
United States | One (1) Location in Oxnard, California | Oxnard | California |
United States | One (1) Location in Florida | Palm Harbor | Florida |
United States | One (1) Location in Missouri | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
DiaSorin Inc. | ICON Clinical Research |
United States, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Helicobacter pylori Stool Collection | In vitro diagnostic (IVD) device performance | Through Study Completion, an average of 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
Terminated |
NCT03316105 -
Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Active, not recruiting |
NCT04353726 -
Knowledge-based Dietary Weight Management.
|
N/A | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT03377244 -
Healthy Body Healthy Souls in the Marshallese Population
|
N/A | |
Completed |
NCT02877004 -
LLLT for Reducing Waste Circumference and Weight
|
N/A | |
Active, not recruiting |
NCT04327141 -
Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women
|
N/A | |
Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
Recruiting |
NCT05249465 -
Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention
|
N/A | |
Recruiting |
NCT05942326 -
Sleep Goal-focused Online Access to Lifestyle Support
|
N/A | |
Completed |
NCT00535600 -
Effects of Bariatric Surgery on Insulin
|
||
Not yet recruiting |
NCT03601273 -
Bariatric Embolization Trial for the Obese Nonsurgical
|
Phase 1 | |
Active, not recruiting |
NCT04357119 -
Common Limb Length in One-anastomosis Gastric Bypass
|
N/A | |
Completed |
NCT03139760 -
POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability
|
N/A | |
Completed |
NCT02948517 -
Time Restricted Feeding for Weight Loss and Cardio-protection
|
N/A | |
Completed |
NCT02945410 -
Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity
|
N/A | |
Completed |
NCT03210207 -
Gastric Plication in Mexican Patients
|
N/A | |
Recruiting |
NCT02559479 -
A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
|
N/A |