Trial Outcomes & Findings for Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD (NCT NCT02699060)
NCT ID: NCT02699060
Last Updated: 2022-02-18
Results Overview
We analyzed the number of acid and weakly acid reflux episodes in GERD patients
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Day 4
Results posted on
2022-02-18
Participant Flow
Participant milestones
| Measure |
GERD
NERD patients, EE patients and BE patients
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non Erosive Reflux Disease
n=28 Participants
Participants not received drugs
|
Erosive Esophagitis
n=22 Participants
Participants not received drugs
|
Barrett's Esophagus
n=18 Participants
Participants not received drugs
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.74 years
STANDARD_DEVIATION 2.23 • n=28 Participants
|
45.0 years
STANDARD_DEVIATION 3.24 • n=22 Participants
|
47.22 years
STANDARD_DEVIATION 2.95 • n=18 Participants
|
46.8 years
STANDARD_DEVIATION 12.4 • n=68 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=28 Participants
|
7 Participants
n=22 Participants
|
5 Participants
n=18 Participants
|
26 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=28 Participants
|
15 Participants
n=22 Participants
|
13 Participants
n=18 Participants
|
42 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
28 Participants
n=28 Participants
|
22 Participants
n=22 Participants
|
18 Participants
n=18 Participants
|
68 Participants
n=68 Participants
|
|
Expression levels macrophage CD markers from GERD patients
CD25
|
34.6 mg/l
STANDARD_DEVIATION 15.9 • n=28 Participants
|
34.2 mg/l
STANDARD_DEVIATION 14.0 • n=22 Participants
|
40.0 mg/l
STANDARD_DEVIATION 14.4 • n=18 Participants
|
36.9 mg/l
STANDARD_DEVIATION 15.2 • n=68 Participants
|
|
Expression levels macrophage CD markers from GERD patients
CD80
|
23.0 mg/l
STANDARD_DEVIATION 13.3 • n=28 Participants
|
23.5 mg/l
STANDARD_DEVIATION 10.0 • n=22 Participants
|
24.4 mg/l
STANDARD_DEVIATION 11.5 • n=18 Participants
|
23.4 mg/l
STANDARD_DEVIATION 11.8 • n=68 Participants
|
|
Expression levels macrophage CD markers from GERD patients
CD163
|
16.6 mg/l
STANDARD_DEVIATION 15.9 • n=28 Participants
|
18.0 mg/l
STANDARD_DEVIATION 10.0 • n=22 Participants
|
14.3 mg/l
STANDARD_DEVIATION 8.1 • n=18 Participants
|
16.3 mg/l
STANDARD_DEVIATION 9.1 • n=68 Participants
|
|
Expression levels macrophage CD markers from GERD patients
CD206
|
10.4 mg/l
STANDARD_DEVIATION 7.2 • n=28 Participants
|
11.9 mg/l
STANDARD_DEVIATION 8.0 • n=22 Participants
|
9.6 mg/l
STANDARD_DEVIATION 7.7 • n=18 Participants
|
10.6 mg/l
STANDARD_DEVIATION 7.5 • n=68 Participants
|
PRIMARY outcome
Timeframe: Day 4We analyzed the number of acid and weakly acid reflux episodes in GERD patients
Outcome measures
| Measure |
NERD Patients
n=28 Participants
Patients with heartburn were found to exhibit inflammatory esophageal mucosa during endoscopy
|
EE Patients
n=22 Participants
Patients with erosions or ulcers in esophagus by endoscopy
|
BE Patients
n=18 Participants
Patients with intestinal metaplasia in esophagus
|
|---|---|---|---|
|
The Number of Reflux in GERD Patients
The acid reflux episodes
|
33.6 episodes
Interval 0.0 to 79.0
|
42.8 episodes
Interval 2.0 to 111.0
|
81.0 episodes
Interval 12.0 to 211.0
|
|
The Number of Reflux in GERD Patients
The weakly acid reflux episodes
|
53.1 episodes
Interval 28.8 to 99.0
|
34.4 episodes
Interval 12.0 to 100.0
|
31.8 episodes
Interval 4.0 to 100.0
|
Adverse Events
NERD Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EE Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BE Patients
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place