A New System for GERD Diagnosis and Treatment

GERD Clinical Trial

— EAISMLP  

Official title:

A New System for Diagnosis and Treatment of Gastroesophageal Refulx Diseases : Based on Endoscopy, pH Parameter, Impedence Parameter, High Resolution Manometry and Psychology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03600974
• Other study ID #: xhnk002
• Status: Not yet recruiting
• Start date: February 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: February 2019
• Source: Capital Medical University
• Contact: Hao Zi Guo, MD
• Phone: 86+15801227696
• Email: zihaoguo[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a pilot study measuring a new diagnosis and treatment system "EAISMLP" in adult patients with gastroesophageal reflux disease (GERD).

Description:

The investigators created a new diagnosis and treatment system for gastroesophageal reflux disease (GERD). The system based on endoscopy, 24h esophageal pH-impedance monitoring, esophagus high resolution manometry and psycological condition.the investigators named it as "EAISMLP" symptom. Each letter in "EAISMLP" is responsible for a typical character and treatment. Subjects will be subtyped according to "EAISMLP" system and underwent treatment, and will be follow up for 6 months and 1 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Male or Female aged =18 years

2. Subjects with refractory reflux symptoms to PPIs standard treatment as follows:

2.1 Ongoing heartburn symptom with or without these GERD-related symptoms :

Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating, Satiety, Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia, Odynophagia, Weight loss.

2.2 Ongoing heartburn symptom with or without erosion = grade A according to LA Classification.

3. Decided to participate and signed on an informed consent form willingly.

Exclusion Criteria:

1. Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening.

2. History of operation in esophagus, stomach or duodenum.

3. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/ pyloric stricture, Primary esophageal spasm, Barrett's esophagus = 3 cm, Zollinger-Ellison syndrome.

4. Infectious or inflammatory bowel disease, Severe malabsorption, Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis.

5. History of cancer within 5 years, except completely recovered skin cancer ALT or AST = Upper limit of normal range X 3.

6. Need antibiotics due to severe infection.

7. Pregnant or breast-feeding women.

8. Conversation impairment because of alcohol, drug addiction or mental illness, etc.

9. Inability to record diary card

10. In investigator's judgement

Related Conditions & MeSH terms

• GERD

Intervention

Procedure:
• Stretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group
• Laparoscopic Nissen fundoplication
Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group

Drug:
• Probiotic Agent
Probiotic Agent for I(+)G/W;Live Bacillus Licheniformis Cranules 0.5g bid; Bifidbacterium 0.63g bid
• PPI
PPIs for A(+),E(+)or S(+) patients: Nexium 20mg Qd/Bid;Lansoprazole 30mg Qd/Bid;omeprazole 10mg-30mg Qd-Bid;Rabeprazole 10mg Qd/Bid;Esomeprazole 20mg Qd/Bid;Pantoprazole 40mg Qd/Bid
• Prokinetic Motility Agents
Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid
• Neuromodulators
Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction of the "EAISMLP system" on GERD symptoms assessed by the HRQL scores.	mean improvement in the GERD-health-related quality of life (HRQL) scores. Scale ranges 0-50 points, the lower score means the better efficacy.	Change from Baseline HRQL scores at 1 month;Change from Baseline HRQL scores at 2 months;Change from Baseline HRQL scores at 6 months;Change from Baseline HRQL scores at 1 year
Secondary	Satisfaction of the "EAISMLP system" on life quality assessed by the SF-36 scores.	mean improvement in SF-36 scores.Scale ranges 0-100 points, the higher score means the better efficacy.	Change from Baseline SF-36 scores at 1 month;Change from Baseline SF-36 scores at 2 months;Change from Baseline SF-36 scores at 6 months;Change from Baseline SF-36 scores at 1 year