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OpenTrials
Completed

NCT Number: NCT05374980

The Effects of Yogurt on Gut Microbiome and Metabolism in H. Pylori.

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Fecal occult blood positive, unexplained iron-deficiency anemia, weight increase or decrease by more than 5% within six months.
  • Abnormal liver function index (AST, ALT or ALP greater than 2 times the upper limit of normal), abnormal renal function index (eGFR less than 45 ml/min).
  • Pregnant or breast-feeding women.

Treatment and study plan

Yogurt

Dietary Supplement

Drink a bottle of 200ml yogurt every morning and evening for 8 weeks

Placebo

Dietary Supplement

Drink a bottle of 200ml placebo every morning and evening for 8 weeks

Primary outcomes

  1. Change of gut Microbiome

    Time frame: Baseline to day 28 and day 56

    uses high-throughput sequencing to sequence the 16S rRNA

Secondary outcomes

  1. Change of C13 urea breath test

    Time frame: Baseline to day 28 and day 56

    Delta urea breath test

Other outcomes

  1. Change of weight

    Time frame: Baseline to day 28 and day 56

    weight in kilograms

  2. Change of waist circumference

    Time frame: Baseline to day 28 and day 56

    waist in centimeters

  3. Change of blood pressure

    Time frame: Baseline to day 28 and day 56

    Change of systolic blood pressure and diastolic blood pressure

  4. Change of HOMA-IR

    Time frame: Baseline to day 28 and day 56

    Glucose and insulin will be combined to report HOMA-IR in (mg/dl x mIU/L)/405

  5. Change of high density lipoprotein

    Time frame: Baseline to day 28 and day 56

    Change of high density lipoprotein in the blood

  6. Change of low density lipoprotein

    Time frame: Baseline to day 28 and day 56

    Change of low density lipoprotein in the blood

  7. Change of Cholesterol

    Time frame: Baseline to day 28 and day 56

    Change of Cholesterol in the blood

  8. Change of Triglyceride

    Time frame: Baseline to day 28 and day 56

    Change of Triglyceride in the blood

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 16, 2022
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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