Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT05483660
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection
Sponsor:
Nanfang Hospital, Southern Medical University
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Double-blind Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans for eradication of Helicobacter Pylori, as well as the efficacy of Lactobacillus plantarum and Bacillus coagulans on side-effect caused by Helicobacter Pylori.
Detailed Description:
All patients included in this randomized controlled clinical trial will be selected according to strict inclusion and exclusion criteria. At the same time, the benefits and risks of participating in this trial will be explained to the patients before the start of the study, the patients' right to informed consent will be respected, and the informed consent will be signed. After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participants and investigator) in a 1:1:1:1 ratio to Lactobacillus plantarum (1.5×10\^10 per time, three times daily) or Bacillus coagulans (1.5×10\^10 per time, three times daily) or Lactobacillus plantarum + Bacillus coagulans (1.5×10\^10 per time, three times daily) or placebo ( 15g per time, three times daily). At the same time, volunteers will be recruited from healthy people to perform the same treatment.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: