Clinical trial NCT05374980: 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
Overall status: COMPLETED
Phase: NA
Conditions: Probiotic
Gut Microbiota
Helicobacter Pylori Infection
Insulin Resistance
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of gut Microbiome
timeFrame: Baseline to day 28 and day 56
Secondary outcomes:
measure: Change of C13 urea breath test
timeFrame: Baseline to day 28 and day 56
Other outcomes:
measure: Change of weight
timeFrame: Baseline to day 28 and day 56
measure: Change of waist circumference
timeFrame: Baseline to day 28 and day 56
measure: Change of blood pressure
timeFrame: Baseline to day 28 and day 56
measure: Change of HOMA-IR
timeFrame: Baseline to day 28 and day 56
measure: Change of high density lipoprotein
timeFrame: Baseline to day 28 and day 56
measure: Change of low density lipoprotein
timeFrame: Baseline to day 28 and day 56
measure: Change of Cholesterol
timeFrame: Baseline to day 28 and day 56
measure: Change of Triglyceride
timeFrame: Baseline to day 28 and day 56
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Han-Chung Lien, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.