A New System for GERD Diagnosis and Treatment

Capital Medical University200 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

GERD

Interventions

StrettaPROCEDURE

Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Laparoscopic Nissen fundoplicationPROCEDURE

Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group

Probiotic AgentDRUG

Probiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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.

Time frame: 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

Central Contacts

Hao Zi Guo, MD

CONTACT

86+15801227696 zihaoguo@139.com

Data from ClinicalTrials.gov

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