Trial Outcomes & Findings for Clinical Experiment of Helicobacter Pylori Transmission (NCT NCT00550368)

NCT ID: NCT00550368

Last Updated: 2016-12-06

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

48 hours

Results posted on

2016-12-06

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	H. Pylori Negative Participants who tested negative for H. pylori infection.	H. Pylori Positive Participants who tested H. pylori positive
Overall Study STARTED	26	19
Overall Study COMPLETED	26	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Experiment of Helicobacter Pylori Transmission

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	H. Pylori Negative n=26 Participants Participants who tested negative for H. pylori infection.	H. Pylori Positive n=19 Participants Participants who tested H. pylori positive	Total n=45 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 7.3 • n=99 Participants	49.4 years STANDARD_DEVIATION 6.7 • n=107 Participants	48.6 years STANDARD_DEVIATION 7 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	4 Participants n=107 Participants	15 Participants n=206 Participants
Sex: Female, Male Male	15 Participants n=99 Participants	15 Participants n=107 Participants	30 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=99 Participants	12 Participants n=107 Participants	17 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=99 Participants	7 Participants n=107 Participants	28 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants	13 Participants n=107 Participants	34 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
BMI	27 kg/m2 STANDARD_DEVIATION 4.5 • n=99 Participants	28.7 kg/m2 STANDARD_DEVIATION 3.8 • n=107 Participants	27.7 kg/m2 STANDARD_DEVIATION 4.3 • n=206 Participants
Gastric pH, Median	1.5 units on a scale n=99 Participants	1.6 units on a scale n=107 Participants	1.5 units on a scale n=206 Participants
Hypochlorhydric	2 participants n=99 Participants	7 participants n=107 Participants	9 participants n=206 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	H. Pylori Negative n=26 Participants Participants who tested negative for H. pylori infection.	H. Pylori Positive n=19 Participants Participants who tested H. pylori positive
Development of Diarrhea	5 participants	6 participants

SECONDARY outcome

Timeframe: 48 hours

Composite gastrointestinal symptom score was on a scale from 0 (no symptoms) to 15 (severe symptoms). This composite was the sum of 5 self-reported, symptom scores, each ranging from 0 (none) to 3 (severe). The self-reported symptoms that subjects scored were: malaise, headache, nausea, vomiting, and loose stool.

Outcome measures

Outcome measures
Measure	H. Pylori Negative n=26 Participants Participants who tested negative for H. pylori infection.	H. Pylori Positive n=19 Participants Participants who tested H. pylori positive
Intensity of Gastrointestinal Symptoms	3 units on a scale Interval 0.0 to 15.0	3 units on a scale Interval 0.0 to 15.0

Adverse Events

H. Pylori Negative

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

H. Pylori Positive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie Parsonnet

Stanford University

Phone: (650) 725-4561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place