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

NCT05374980 | Completed

• 1 other identifier: SF19354B
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Probiotic; Gut Microbiota; Helicobacter Pylori Infection; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change of gut Microbiome

  uses high-throughput sequencing to sequence the 16S rRNA

  Baseline to day 28 and day 56

Secondary Outcomes (1)

• Change of C13 urea breath test

  Baseline to day 28 and day 56

Other Outcomes (8)

• Change of weight

  Baseline to day 28 and day 56

• Change of waist circumference

  Baseline to day 28 and day 56

• Change of blood pressure

  Baseline to day 28 and day 56

Study Arms (3)

Yogurt

EXPERIMENTAL

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

Dietary Supplement: Yogurt

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Healthy volunteer

NO INTERVENTION

Patients with Helicobacter pylori negative (ΔUBT\<2%) need blood test and collect stool samples at first, and collect stool samples again after 2 months.

Interventions

Yogurt DIETARY_SUPPLEMENT

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

Yogurt

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 19457415 RESULT

• 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.

  PMID: 29504247 RESULT

• 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.

  PMID: 30296434 RESULT

• 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.

  PMID: 29600573 RESULT

• 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.

  PMID: 25582223 RESULT

MeSH Terms

Conditions

Insulin Resistance

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Han-Chung Lien, MDPHD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator of Gastrointestinal Motility Lab

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 16, 2022
• Study Start: January 1, 2022
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)