ProbioticNCT05374980
The Effects of Yogurt on Gut Microbiome and Metabolism in H. Pylori.
A study testing Yogurt in people with Probiotic and Gut Microbiota, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Probiotic, Gut Microbiota, Helicobacter Pylori Infection
- What is being tested?
- Yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 16 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Yogurt, Placebo
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogurtDietary supplement
Drink a bottle of 200ml yogurt every morning and evening for 8 weeks
PlaceboDietary supplement
Drink a bottle of 200ml placebo every morning and evening for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Yogurt | Experimental | Drink a bottle of 200ml yogurt every morning and evening for 8 weeks Receives: Dietary Supplement: Yogurt |
| Placebo | Placebo comparator | Drink a bottle of 200ml placebo every morning and evening for 8 weeks Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gut Microbiome
uses high-throughput sequencing to sequence the 16S rRNA
Measured: Baseline to day 28 and day 56
Secondary outcomes (1)
Change of C13 urea breath test
Delta urea breath test
Measured: Baseline to day 28 and day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Jan 2022
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ProbioticStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Chung, Lien, Taichung Veterans General Hospital
- Investigators
- Han-Chung Lien, MDPHD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374980
- Sponsor's protocol ID
- SF19354B
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19457415Sugizaki 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.
PubMed 29504247Butt 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.
PubMed 30296434Park 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.
PubMed 29600573Chen 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.
PubMed 25582223
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fermented Milk Product With Probiotic on Helicobacter Pylori Infection, Gut Microbiome and Metabolism.
- ClinicalTrials.gov ID
- NCT05374980
- Acronym / sponsor ID
- SF19354B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yogurt | Experimental | Dietary Supplement: YogurtDrink a bottle of 200ml yogurt every morning and evening for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDrink a bottle of 200ml placebo every morning and evening for 8 weeks |
| 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogurtDrink a bottle of 200ml yogurt every morning and evening for 8 weeks | Dietary supplement | Yogurt |
| PlaceboDrink a bottle of 200ml placebo every morning and evening for 8 weeks | Dietary supplement | Placebo |
Primary outcome
Change of gut Microbiome
Time frame: Baseline to day 28 and day 56
uses high-throughput sequencing to sequence the 16S rRNA
1 secondary outcome
Change of C13 urea breath test
Time frame: Baseline to day 28 and day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Results publication: PubMed 19457415Cover 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 publication: PubMed 29504247Sugizaki 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 publication: PubMed 30296434Butt 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 publication: PubMed 29600573Park 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 publication: PubMed 25582223Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Chung Lien, MDPHD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt in people with Probiotic and Gut Microbiota, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of gut Microbiome (time frame: Baseline to day 28 and day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374980, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.