Efficacy and Safety of Helicobacter Project Will
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002707
- Lead Sponsor
- Kyung Hee University Hosipital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 170
(1) Male and Female adult aged 19 - 70 years
(2) Adult was diagnosed with H. pylori (+) in recent one year and did not have H. pylori eradication
(3) Infomed consent form
1) had a prescription for medications including PPI (Proton Pump Inhibitor)/Histamin-2 blocker, antibiotics for example clarithromycin, amoxicillin, metronidazole or tetracycline, mucosal protector such as bismuth steroid, NSAID, probiotics less than 2 weeks before the screening visit;
2) consumed dietary supplements potentially interfering with this trial (such as probiotics, prebiotics, or fiber);
3) exhibited alarm signs (e.g., abnormal weight loss, hematochezia, anemia, or significant bowel habit changes);
4) had neurological or psychiatric disorders;
5) were pregnant or breastfeeding;
6) were drug users or alcoholics;
7) had undergone a previous colorectal operation; and
8) had significant laboratory abnormalities
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Interval change in 13 C-Urea Breath Test
- Secondary Outcome Measures
Name Time Method Positive rate of H. pylori measued by 13 C-Urea Breath Test;Positive rate of H. pylori measued by Campylobacter-like organism test;infection degree of H. pylori measued by Sydney system through tissue biopsy;Interval change in fecal microbiome;GI symptoms measured by Gastrointestinal Symptom Rating Scale;questionnaire about Gastrointestinal symptoms;Quality of Life measured by WHOQOL-BREF (World Health Organization Quality of Life Assessment Instrument