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

April 11, 2023 updated by: Han-Chung, Lien, Taichung Veterans General Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unhealthy habits or poor health status, including habitual smoking, alcoholism, polypharmacy or drug abuses.
  2. Patients with acute diseases, such as respiratory tract infection, acute gastroenteritis.
  3. 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.
  4. Those who have had gastrointestinal cancer or have undergone gastrointestinal surgery.
  5. Those who are unwilling to delay receiving Anti-H. pylori therapy.
  6. Newly diagnosed cancer (except basal cell carcinoma) or cancer treatment in the past 5 years.
  7. 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.
  8. Diabetes and those who are or need to take drugs.
  9. Those who have used the following drugs in the past month: antibiotics, NSAIDs, obesity drugs, steroid therapy, proton pump inhibitors, bismuth agents.
  10. 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.
  11. Fecal occult blood positive, unexplained iron-deficiency anemia, weight increase or decrease by more than 5% within six months.
  12. 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).
  13. Pregnant or breast-feeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yogurt
Drink a bottle of 200ml yogurt every morning and evening for 8 weeks
Dietary supplement: Yogurt
Drink a bottle of 200ml yogurt every morning and evening for 8 weeks
Placebo Comparator: Placebo
Drink a bottle of 200ml placebo every morning and evening for 8 weeks
Dietary supplement: Placebo
Drink a bottle of 200ml placebo every morning and evening for 8 weeks
No Intervention: Healthy volunteer
Patients with Helicobacter pylori negative (ΔUBT<2%) need blood test and collect stool samples at first, and collect stool samples again after 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of gut Microbiome
Time Frame: Baseline to day 28 and day 56
uses high-throughput sequencing to sequence the 16S rRNA
Baseline to day 28 and day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of C13 urea breath test
Time Frame: Baseline to day 28 and day 56
Delta urea breath test
Baseline to day 28 and day 56

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of weight
Time Frame: Baseline to day 28 and day 56
weight in kilograms
Baseline to day 28 and day 56
Change of waist circumference
Time Frame: Baseline to day 28 and day 56
waist in centimeters
Baseline to day 28 and day 56
Change of blood pressure
Time Frame: Baseline to day 28 and day 56
Change of systolic blood pressure and diastolic blood pressure
Baseline to day 28 and day 56
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
Baseline to day 28 and day 56
Change of high density lipoprotein
Time Frame: Baseline to day 28 and day 56
Change of high density lipoprotein in the blood
Baseline to day 28 and day 56
Change of low density lipoprotein
Time Frame: Baseline to day 28 and day 56
Change of low density lipoprotein in the blood
Baseline to day 28 and day 56
Change of Cholesterol
Time Frame: Baseline to day 28 and day 56
Change of Cholesterol in the blood
Baseline to day 28 and day 56
Change of Triglyceride
Time Frame: Baseline to day 28 and day 56
Change of Triglyceride in the blood
Baseline to day 28 and day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: Han-Chung Lien, MDPHD, Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

February 16, 2023

Study Completion (Actual)

February 16, 2023

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF19354B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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