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The efficacy and safety of parallel randomized, double blind, placebo controlled clinical trial for the inhibition of lactobacillus plant CCFM8610 to helicobacter pylori

Study of probiotic bacteria inhibition of helicobacter pylori infection

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038944
Enrollment
Unknown
Registered
2020-10-10
Start date
2020-10-15
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Infection of Helicobacter pylori

Interventions

Sponsors

Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Pass the 14C-urea breath test, rapid urease test or histological examination, and be diagnosed with Helicobacter pylori infection within 12 months of enrollment; (2) Aged 18-65 years, male and female; (3) The general health condition is good, but according to the investigator's judgment, whether eradication treatment is needed; (4) Understand the ability required for learning and promise to cooperate with the research during the entire experiment period; (5) Willing to provide written informed consent and basic situation survey form; (6) No anti-pyloric treatment has been performed before.

Exclusion criteria

Exclusion criteria: (1) Gastrointestinal surgery (except appendectomy); (2) Allergy to triple antibiotics or eradication of any contraindications; (3) Pregnant or lactating women; (4) Any historical serious disease (severe cardiovascular, endocrine, liver and kidney dysfunction, etc.) before the eradication of Helicobacter pylori treatment; (5) If the patient took probiotics, antibiotics or research products one month before enrollment, they will also be excluded; (6) Having mental illness, which may cause difficulties in cooperation; (7) Patients who lack self-judgment ability; (8) Alcohol or drug abusers; (9) Subjects participating in other clinical trials; (10) The purpose of the researcher's notification to the researcher; (11) Those that do not meet the research requirements or the researchers think they should not participate in the research.

Design outcomes

Primary

MeasureTime frame
14C breath test;Fecal Metagenome;Blood biochemical examination;Blood routine examination;anti-Hp IgG;TNF-a;Serum cytokines;

Countries

China

Contacts

Public ContactQixiao Zhai

School of Food Science and Technology, Jiangnan University

zhaiqixiao@jiangnan.edu.cn+86 15961760920

Outcome results

None listed

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