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| Name | Class |
|---|---|
| Taiwan Sugar Cooperation Company | UNKNOWN |
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We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in this double blind, placebo controlled, randomized trial.
Subjects: Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial. We will screen 150 subjects and it is estimated that 40 H. pylori infected subjects will be eligible. Eligible subjects will be randomized to receive probiotic (Lactobacillus acidophilus and Lactobacillus rhamnosus) or placebo, one pack twice daily, for 28 days. The primary outcome was the reduction in H. pylori load of greater than 20% than baseline. The secondary outcome was the impact of the probiotic on the gut microbiota and the adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | subjects will be treated with probiotic containing Lactobacillus acidophilus,Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks |
|
| Placebo | Placebo Comparator | subjects will be treated with placebo without Lactobacillus acidophilus,Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of bacterial load of H. pylori | after 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| changes in gut microbiota | after 4 weeks of treatment | |
| adverse effects | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jyh-Ming Liou, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34708471 | Derived | Chen MJ, Chen CC, Huang YC, Tseng CC, Hsu JT, Lin YF, Fang YJ, Wu MS, Liou JM; Taiwan Gastrointestinal Disease, Helicobacter Consortium. The efficacy of Lactobacillus acidophilus and rhamnosus in the reduction of bacterial load of Helicobacter pylori and modification of gut microbiota-a double-blind, placebo-controlled, randomized trial. Helicobacter. 2021 Dec;26(6):e12857. doi: 10.1111/hel.12857. Epub 2021 Oct 27. |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Other | Placebo without Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks |
|
| D019602 |
| Food and Beverages |