Back to resultsThe Effects of Yogurt on Gut Microbiome and Metabolism in H. Pylori.
Primary Purpose
Probiotic, Gut Microbiota, Helicobacter Pylori Infection
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Yogurt
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Probiotic
Eligibility Criteria
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.
Sites / Locations
- Taichung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Yogurt
Placebo
Healthy volunteer
Arm Description
Drink a bottle of 200ml yogurt every morning and evening for 8 weeks
Drink a bottle of 200ml placebo every morning and evening for 8 weeks
Patients with Helicobacter pylori negative (ΔUBT<2%) need blood test and collect stool samples at first, and collect stool samples again after 2 months.
Outcomes
Primary Outcome Measures
Change of gut Microbiome
uses high-throughput sequencing to sequence the 16S rRNA
Secondary Outcome Measures
Change of C13 urea breath test
Delta urea breath test
Full Information
NCT ID
NCT05374980
First Posted
April 13, 2022
Last Updated
April 11, 2023
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05374980
Brief Title
The Effects of Yogurt on Gut Microbiome and Metabolism in H. Pylori.
Official Title
The Effects of Fermented Milk Product With Probiotic on Helicobacter Pylori Infection, Gut Microbiome and Metabolism.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 16, 2023 (Actual)
Study Completion Date
February 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Probiotic, Gut Microbiota, Helicobacter Pylori Infection, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yogurt
Arm Type
Experimental
Arm Description
Drink a bottle of 200ml yogurt every morning and evening for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drink a bottle of 200ml placebo every morning and evening for 8 weeks
Arm Title
Healthy volunteer
Arm Type
No Intervention
Arm Description
Patients with Helicobacter pylori negative (ΔUBT<2%) need blood test and collect stool samples at first, and collect stool samples again after 2 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt
Intervention Description
Drink a bottle of 200ml yogurt every morning and evening for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Drink a bottle of 200ml placebo every morning and evening for 8 weeks
Primary Outcome Measure Information:
Title
Change of gut Microbiome
Description
uses high-throughput sequencing to sequence the 16S rRNA
Time Frame
Baseline to day 28 and day 56
Secondary Outcome Measure Information:
Title
Change of C13 urea breath test
Description
Delta urea breath test
Time Frame
Baseline to day 28 and day 56
Other Pre-specified Outcome Measures:
Title
Change of weight
Description
weight in kilograms
Time Frame
Baseline to day 28 and day 56
Title
Change of waist circumference
Description
waist in centimeters
Time Frame
Baseline to day 28 and day 56
Title
Change of blood pressure
Description
Change of systolic blood pressure and diastolic blood pressure
Time Frame
Baseline to day 28 and day 56
Title
Change of HOMA-IR
Description
Glucose and insulin will be combined to report HOMA-IR in (mg/dl x mIU/L)/405
Time Frame
Baseline to day 28 and day 56
Title
Change of high density lipoprotein
Description
Change of high density lipoprotein in the blood
Time Frame
Baseline to day 28 and day 56
Title
Change of low density lipoprotein
Description
Change of low density lipoprotein in the blood
Time Frame
Baseline to day 28 and day 56
Title
Change of Cholesterol
Description
Change of Cholesterol in the blood
Time Frame
Baseline to day 28 and day 56
Title
Change of Triglyceride
Description
Change of Triglyceride in the blood
Time Frame
Baseline to day 28 and day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Chung Lien, MDPHD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19457415
Citation
Cover TL, Blaser MJ. Helicobacter pylori in health and disease. Gastroenterology. 2009 May;136(6):1863-73. doi: 10.1053/j.gastro.2009.01.073. Epub 2009 May 7.
Results Reference
result
PubMed Identifier
29504247
Citation
Sugizaki K, Tari A, Kitadai Y, Oda I, Nakamura S, Yoshino T, Sugiyama T. Anti-Helicobacter pylori therapy in localized gastric mucosa-associated lymphoid tissue lymphoma: A prospective, nationwide, multicenter study in Japan. Helicobacter. 2018 Apr;23(2):e12474. doi: 10.1111/hel.12474. Epub 2018 Mar 4.
Results Reference
result
PubMed Identifier
30296434
Citation
Butt J, Varga MG, Blot WJ, Teras L, Visvanathan K, Le Marchand L, Haiman C, Chen Y, Bao Y, Sesso HD, Wassertheil-Smoller S, Ho GYF, Tinker LE, Peek RM, Potter JD, Cover TL, Hendrix LH, Huang LC, Hyslop T, Um C, Grodstein F, Song M, Zeleniuch-Jacquotte A, Berndt S, Hildesheim A, Waterboer T, Pawlita M, Epplein M. Serologic Response to Helicobacter pylori Proteins Associated With Risk of Colorectal Cancer Among Diverse Populations in the United States. Gastroenterology. 2019 Jan;156(1):175-186.e2. doi: 10.1053/j.gastro.2018.09.054. Epub 2018 Oct 6.
Results Reference
result
PubMed Identifier
29600573
Citation
Park H, Park JJ, Park YM, Baik SJ, Lee HJ, Jung DH, Kim JH, Youn YH, Park H. The association between Helicobacter pylori infection and the risk of advanced colorectal neoplasia may differ according to age and cigarette smoking. Helicobacter. 2018 Jun;23(3):e12477. doi: 10.1111/hel.12477. Epub 2018 Mar 29.
Results Reference
result
PubMed Identifier
25582223
Citation
Chen TP, Hung HF, Chen MK, Lai HH, Hsu WF, Huang KC, Yang KC. Helicobacter Pylori Infection is Positively Associated with Metabolic Syndrome in Taiwanese Adults: a Cross-Sectional Study. Helicobacter. 2015 Jun;20(3):184-91. doi: 10.1111/hel.12190. Epub 2015 Jan 12.
Results Reference
result
Learn more about this trial
The Effects of Yogurt on Gut Microbiome and Metabolism in H. Pylori.
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