Trial record 2 of 4 for: "Achlorhydria"

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Clinical Experiment of Helicobacter Pylori Transmission

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Julie Parsonnet, Stanford University

ClinicalTrials.gov Identifier:

NCT00550368

First received: October 25, 2007

Last updated: October 13, 2016

Last verified: October 2016

History of Changes

Results First Received: February 23, 2016

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Basic Science
Conditions:	Infection Achlorhydria
Intervention:	Biological: Biological intervention: Enteropathogenic E. coli

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited for the study from 2005 to 2008. Enrollment began 6/2005 and ended 5/2008. Healthy individuals were sought with no chronic medical conditions or symptoms.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were assigned to one of two groups: Helicobacter pylori positive, or Helicobacter pylori negative. Assignment was based on results of H. pylori serology and Urea Breath Test. Test results had to be concordant for group assignment.

Reporting Groups

	Description
H. Pylori Negative	Participants who tested negative for H. pylori infection.
H. Pylori Positive	Participants who tested H. pylori positive

Participant Flow: Overall Study

	H. Pylori Negative	H. Pylori Positive
STARTED	26	19
COMPLETED	26	19
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
H. Pylori Negative	Participants who tested negative for H. pylori infection.
H. Pylori Positive	Participants who tested H. pylori positive
Total	Total of all reporting groups

Baseline Measures

	H. Pylori Negative	H. Pylori Positive	Total
Overall Participants Analyzed [Units: Participants]	26	19	45

Age [Units: Years] Mean (Standard Deviation)	48.1 (7.3)	49.4 (6.7)	48.6 (7)

Gender [Units: Participants]
Female	11	4	15
Male	15	15	30

Ethnicity (NIH/OMB) [Units: Participants]
Hispanic or Latino	5	12	17
Not Hispanic or Latino	21	7	28
Unknown or Not Reported	0	0	0

Race (NIH/OMB) [Units: Participants]
American Indian or Alaska Native	0	0	0
Asian	2	2	4
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	3	5
White	21	13	34
More than one race	1	1	2
Unknown or Not Reported	0	0	0

BMI [Units: Kg/m2] Mean (Standard Deviation)	27 (4.5)	28.7 (3.8)	27.7 (4.3)

Gastric pH, Median [Units: Units on a scale] Median (Full Range)	1.5 (1.1 to 6.8)	1.6 (1.2 to 7.5)	1.5 (1.1 to 7.5)

Hypochlorhydric [Units: Participants]	2	7	9

Outcome Measures

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1. Primary:

Development of Diarrhea [ Time Frame: 48 hours ]

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2. Secondary:

Intensity of Gastrointestinal Symptoms [ Time Frame: 48 hours ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Julie Parsonnet
Organization: Stanford University
phone: (650) 725-4561
e-mail: parsonnt@stanford.edu

Responsible Party:	Julie Parsonnet, Stanford University
ClinicalTrials.gov Identifier:	NCT00550368 History of Changes
Obsolete Identifiers:	NCT00549224
Other Study ID Numbers:	688
Study First Received:	October 25, 2007
Results First Received:	February 23, 2016
Last Updated:	October 13, 2016

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