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This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B. infantis 35624 | Experimental | B. infantis 35624 in white capsules |
|
| placebo | Placebo Comparator | white placebo capsules (inert) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. infantis 35624 | Dietary Supplement | B. infantis 35624 in white capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in abdominal discomfort and bloating | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Brum, MD | P&G | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chicago | Illinois | 60610 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27845337 | Derived | Ringel-Kulka T, McRorie J, Ringel Y. Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. Am J Gastroenterol. 2017 Jan;112(1):145-151. doi: 10.1038/ajg.2016.511. Epub 2016 Nov 15. |
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| placebo |
| Dietary Supplement |
white placebo capsules |
|
| Rockford |
| Illinois |
| 61107 |
| United States |
| Research Site | Indianapolis | Indiana | 46240 | United States |
| Research Site | Chevy Chase | Maryland | 20815 | United States |
| Research Site | Chapel Hill | North Carolina | 27999 | United States |
| Research Site | Greensboro | North Carolina | 27403 | United States |
| Research Site | Cincinnati | Ohio | 45249 | United States |
| Research Site | Greer | South Carolina | 29651 | United States |
| Research Site | Nashville | Tennessee | 37205 | United States |
| Research Site | Charlottesville | Virginia | 22911 | United States |