Skip to content

Comparison of the efficacy of fucoidan enriched powder combined with quadruple therapy and standard quadruple therapy in eradicating Helicobacter pylori

Comparison of the efficacy of fucoidan enriched powder combined with quadruple therapy and standard quadruple therapy in eradicating Helicobacter pylori

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023981
Enrollment
Unknown
Registered
2019-06-20
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection of stomach

Interventions

1:Standard quadruple therapy
2: Standard quadruple therapy combined with fucoidan enriched powder
3:Fucoidan enriched powder

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The age ranged from 18 to 70 years, and the gender was not limited. The first diagnosis of Helicobacter pylori positive was made by 14C/13C-urea breath test or gastroscopic biopsy (untreated). 2. Those who did not use antibiotics, probiotics or bismuth agents within 4 weeks before treatment and those who did not use proton pump inhibitors, H2 receptor antagonists, gastric mucosal protective agents and fucoidan polysaccharide preparations for Helicobacter pylori eradication within 2 weeks before treatment. 3. Knowing the research plan and agreeing to cooperate with the treatment and follow-up before enrollment; 4. From the signing of the informed consent to the end of the trial, they agreed to take effective contraceptive measures.

Exclusion criteria

Exclusion criteria: 1. Subjects suffered from any unstable or uncontrolled cardiovascular, pulmonary, liver, kidney, gastrointestinal tract, urogenital, hematological, coagulation, immunology, endocrine/metabolic or other medical diseases, which the researchers believed would interfere with the results of the study or endanger the safety of the subjects; 2. During the screening period, the results of any of the following laboratory tests were abnormal: a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x upper limit of normal value (ULN); B. Direct bilirubin > 1.5xULN; C. Serum creatinine > 1.5 times higher limit of normal value; 3. Subjects'previous severe allergic history (e.g. drug allergy), allergies to penicillin or contraindications to any proton pump inhibitors (including but not limited to: lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole or eprazole): 4. Subjects need to use non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 non-steroidal anti-inflammatory drugs, for a long period of time (>12 doses/month) within 30 days before the treatment of experimental drugs and throughout the study period. 5. Pregnancy and lactation patients; 6. Within one year before screening, the subjects had a history of drug abuse (defined as the use of any illicit drug) or alcohol abuse. 7. Subjects suffered from active psychosis, which may interfere with their compliance with the research process. 8. Subjects are unable to participate in all research visits or follow the research process. 9. He has participated in or is participating in other clinical studies within 9 or 3 months. 10. Researchers believe that there are any unsuitable candidates.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori clearance rate;

Countries

China

Contacts

Public ContactYanan Yu

Affiliated Hospital of Qingdao University

yananyu1985@163.com+86 18661801673

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026