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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374980
• Other study ID #: SF19354B
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: February 16, 2023

Study information

• Verified date: April 2023
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 16, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age between 20 to 70 years old with positive Helicobacter pylori gastric C13 urea breath test (?UBT>10%).

2. Negative gastric Helicobacter (?UBT<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.

Related Conditions & MeSH terms

• Gut Microbiota
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections
• Insulin Resistance
• Probiotic

Intervention

Dietary Supplement:
• Yogurt
Drink a bottle of 200ml yogurt every morning and evening for 8 weeks
• Placebo
Drink a bottle of 200ml placebo every morning and evening for 8 weeks

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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, — View 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 20 — View 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. — View 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 — View 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of weight	weight in kilograms	Baseline to day 28 and day 56
Other	Change of waist circumference	waist in centimeters	Baseline to day 28 and day 56
Other	Change of blood pressure	Change of systolic blood pressure and diastolic blood pressure	Baseline to day 28 and day 56
Other	Change of HOMA-IR	Glucose and insulin will be combined to report HOMA-IR in (mg/dl x mIU/L)/405	Baseline to day 28 and day 56
Other	Change of high density lipoprotein	Change of high density lipoprotein in the blood	Baseline to day 28 and day 56
Other	Change of low density lipoprotein	Change of low density lipoprotein in the blood	Baseline to day 28 and day 56
Other	Change of Cholesterol	Change of Cholesterol in the blood	Baseline to day 28 and day 56
Other	Change of Triglyceride	Change of Triglyceride in the blood	Baseline to day 28 and day 56
Primary	Change of gut Microbiome	uses high-throughput sequencing to sequence the 16S rRNA	Baseline to day 28 and day 56
Secondary	Change of C13 urea breath test	Delta urea breath test	Baseline to day 28 and day 56