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Clinical Trials/NCT05374980
NCT05374980
Completed
Not Applicable

The Effects of Fermented Milk Product With Probiotic on Helicobacter Pylori Infection, Gut Microbiome and Metabolism.

Taichung Veterans General Hospital1 site in 1 country51 target enrollmentStarted: January 1, 2022Last updated:
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ConditionsProbioticGut MicrobiotaHelicobacter Pylori InfectionInsulin Resistance

Overview

Phase
Not Applicable
Status
Completed
Enrollment
51
Locations
1
Primary Endpoint
Change of gut Microbiome
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Helicobacter pylori is a common pathogen causing upper gastrointestinal diseases including gastric ulcer and gastric cancer. Recent epidemiological findings have also shown that it is also related to colon cancer, metabolic syndrome, gut dysbiosis, glycemic control and insulin resistance.

The aim of this study is to investigate whether the gut microbiota and insulin resistance of patients with H. pylori infection are abnormal. In addition, whether drinking fermented milk product with probiotic reduces Helicobacter pylori, improves gut microbiota, and increases butyrate-producing bacteria and insulin resistance.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age between 20 to 70 years old with positive Helicobacter pylori gastric C13 urea breath test (ΔUBT\>10%).
  • •Negative gastric Helicobacter (ΔUBT\<2%) matching age, gender, and body mass index.

Exclusion Criteria

  • •Unhealthy habits or poor health status, including habitual smoking, alcoholism, polypharmacy or drug abuses.
  • •Patients with acute diseases, such as respiratory tract infection, acute gastroenteritis.
  • •In the past three months, those who have had dyspepsia but have not undergone gastroscopy, or have a history of active gastrointestinal ulcers and gastrointestinal bleeding.
  • •Those who have had gastrointestinal cancer or have undergone gastrointestinal surgery.
  • •Those who are unwilling to delay receiving Anti-H. pylori therapy.
  • •Newly diagnosed cancer (except basal cell carcinoma) or cancer treatment in the past 5 years.
  • •People who have had cardiovascular disease, respiratory disease, autoimmune disease, mental disease or other chronic diseases that are not well controlled, such as myocardial infarction or stroke, chronic obstructive pulmonary disease, inflammatory bowel disease, Schizophrenia.
  • •Diabetes and those who are or need to take drugs.
  • •Those who have used the following drugs in the past month: antibiotics, NSAIDs, obesity drugs, steroid therapy, proton pump inhibitors, bismuth agents.
  • •In the past month, regularly consume the following foods (at least 2 times a week): probiotics, prebiotics, or any foods containing probiotics, dairy products (yogurt, cheese), Chinese medicine, kimchi, miso, honey, cranberry, spicy food.

Outcomes

Primary Outcomes

Change of gut Microbiome

Time Frame: Baseline to day 28 and day 56

uses high-throughput sequencing to sequence the 16S rRNA

Secondary Outcomes

  • Change of C13 urea breath test(Baseline to day 28 and day 56)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Han-Chung, Lien

Principle Investigator of Gastrointestinal Motility Lab

Taichung Veterans General Hospital

Study Sites (1)

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