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Trial Outcomes & Findings for Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease (NCT NCT02114216)

NCT ID: NCT02114216

Last Updated: 2016-05-02

Results Overview

The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers' instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

up to 24weeks

Results posted on

2016-05-02

Participant Flow

The subjects were enrolled prospectively at Seoul National University Bundang Hospital between March 2010 and August 2014. Those enrolled subjects visited SNUBH gastroenterology department mainly for evaluating the origin of suspicious GERD symptoms or for screening of gastric cancer.

Subjects were excluded if there was a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus).

Participant milestones

Participant milestones
Measure
Control Group
subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
ERD Group
subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
NERD Group
subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
Overall Study
STARTED
16
45
14
Overall Study
COMPLETED
16
45
14
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group
n=16 Participants
subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
ERD Group
n=45 Participants
subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
NERD Group
n=14 Participants
subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
Total
n=75 Participants
Total of all reporting groups
Age, Continuous
54.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
52.3 years
STANDARD_DEVIATION 10.39 • n=7 Participants
52.7 years
STANDARD_DEVIATION 13.8 • n=5 Participants
52.8 years
STANDARD_DEVIATION 12.1 • n=4 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
22 Participants
n=7 Participants
7 Participants
n=5 Participants
38 Participants
n=4 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
23 Participants
n=7 Participants
7 Participants
n=5 Participants
37 Participants
n=4 Participants

PRIMARY outcome

Timeframe: up to 24weeks

The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers' instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.

Outcome measures

Outcome measures
Measure
Control Group
n=16 Participants
subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
ERD Group
n=45 Participants
subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
NERD Group
n=14 Participants
subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
TRPV1, GDNF, and NGF mRNA Expression of Esophageal Mucosa
TRPV1
1.14 Fold change
Standard Error 0.25
3.25 Fold change
Standard Error 0.32
2.33 Fold change
Standard Error 0.22
TRPV1, GDNF, and NGF mRNA Expression of Esophageal Mucosa
GDNF
1.39 Fold change
Standard Error 0.35
2.47 Fold change
Standard Error 0.33
2.05 Fold change
Standard Error 0.16
TRPV1, GDNF, and NGF mRNA Expression of Esophageal Mucosa
NGF
1.62 Fold change
Standard Error 0.37
2.65 Fold change
Standard Error 0.21
2.29 Fold change
Standard Error 0.13

SECONDARY outcome

Timeframe: up to 24weeks

The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers' instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.

Outcome measures

Outcome measures
Measure
Control Group
n=16 Participants
subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
ERD Group
n=45 Participants
subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
NERD Group
n=14 Participants
subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
PAR2 and IL-8 Expression of Esophageal Mucosa
PAR2
1.37 Fold change
Standard Error 0.20
2.42 Fold change
Standard Error 0.17
2.29 Fold change
Standard Error 0.36
PAR2 and IL-8 Expression of Esophageal Mucosa
IL8
2.01 Fold change
Standard Error 0.60
4.36 Fold change
Standard Error 0.32
4.01 Fold change
Standard Error 0.35

Adverse Events

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

ERD Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

NERD Group

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. Jinjoo Kim

Seoul National University Hospital

Phone: 82-10-6261-6483

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place