Gastric Mucosa Injury
Conditions
Interventions
Placebo:orally take placebo
Formula:orally take formula
Sponsors
Xin Hua Hospital
Eligibility
Sex/Gender
All
Age
25 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female volunteers aged 25 to 45 years old (25 to 35 years:35 to 45 years old = 8:2); 2. The gastric mucosal injury was diagnosed and confirmed by an upper gastrointestinal endoscopy; 3. Meet the diagnostic criteria for chronic superficial gastritis: prolonged course, different degrees of dyspepsia, upper abdominal pain, heartburn, belching, acid reflux, bloating and other symptoms, and with or without mild upper abdominal tenderness; 4. No abnormal findings on chest X-ray, electrocardiogram, and abdominal B-mode ultrasound; 5. No abnormal findings on liver and kidney function tests; 6. No abnormal findings on blood, urine, and fecal lab tests; 7. No abnormal findings with vital signs; 8. Willing to obey all research requirements and procedures and agreed to sign an informed consent; 9. Participants agree not to enroll in another interventional clinical research study while participating in this study.
Exclusion criteria
Exclusion criteria: 1. Severe heart disease, severe acute oral and oropharynx disease, esophagus stenosis or obstruction of the cardia of stomach NOT appropriate an upper gastrointestinal endoscopy; 2. Current pregnant or lactating mother; 3. All allergy participants; 4. Had participated in a similar clinical trial in the past 6 months; 5. Any secondary disease to chronic superficial gastritis; 6. Participant has any severe cardiovascular, cerebrovascular, liver, kidney and hematopoietic disease; 7. Participant has any mental illness; 8. Participant frequently takes any drug, consume alcohol, smoke and had participated in any clinical trial in the past 4 weeks; 9. Participant had taken any drug known to interrupt the stomach and intestine normal function in the past 3 months; 10. Participant has any disease with severe clinical symptoms and signs according to investigator's clinical judgment; 11. Participant has any severe gastrointestinal ulcer; 12. Participant is currently taking any drug or receiving any treatment; 13. Failing to take study products continuously 3 days per instruction which may interrupt the evaluation of the safety, efficacy of the study product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastric mucosal damage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported assessment of gastrointestinal discomforts;Carbon-13 urea breath test;Fecal calprotectin and short-chain fatty acids;Liver and kidney function;Body weight and BMI;Life quality and sleep questionnaires;Metagenomics; | — |
Countries
China
Contacts
Public ContactJuntao Kan
Amway (China) R&D Center
Outcome results
None listed