Clinical trial · Observational
Intestine Bacteria and Breast Cancer Risk
BRANCH:Fecal Microbiota Among Participants in a Pre-paid Health Plan
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: \- Some bacteria found in the large and small intestines help keep people healthy and aid digestion. They may also affect a person s risk of developing cancer. Researchers want to study the relationship between intestinal bacteria and breast cancer risk factors. They can do this by looking at stool and urine samples from postmenopausal women. Objectives: \- To study intestinal bacteria and its relationship to urine-based markers of breast cancer risk in women. Eligibility: \- Women between 55 and 69 years of age with a recent mammogram that showed no signs of cancer. Design: * Participants will be screened with a medical history and basic health questionnaire. * At home, participants will complete questionnaires about cancer risk factors and food consumption. * Participants will also collect urine and stool samples. They will send the samples to the designated labs for study. * No treatment will be provided as part of this protocol.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Breast Cancer Cases
- description
- Breast Cancer Cases
- label
- Controls
- description
- Controls
Primary outcomes (1)
- measure
- Breast cancer association
- timeFrame
- cross-sectional
- description
- breast cancer association
Secondary outcomes (1)
- measure
- Fecal microbiome-systemic estrogen association
- timeFrame
- cross-sectional
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
* INCLUSION CRITERIA: Female members of Kaiser Permanente Colorado (KPCO) with a recent normal mammogram who gets into a random sample of the very large population. EXCLUSION CRITERIA: History of cancer, except non-melanoma skin cancer History of inflammatory bowel disease or diverticulitis History of gastric banding or by-pass surgery History of other gastric or intestinal surgery within the previous 6 months Hormone prescription within the previous 12 months Antibiotic prescription within the previous 6 months.
References
Publications (3)
- BACKGROUNDFuhrman BJ, Feigelson HS, Flores R, Gail MH, Xu X, Ravel J, Goedert JJ. Associations of the fecal microbiome with urinary estrogens and estrogen metabolites in postmenopausal women. J Clin Endocrinol Metab. 2014 Dec;99(12):4632-40. doi: 10.1210/jc.2014-2222. PMID 25211668
- BACKGROUNDFeigelson HS, Bischoff K, Ardini MA, Ravel J, Gail MH, Flores R, Goedert JJ. Feasibility of self-collection of fecal specimens by randomly sampled women for health-related studies of the gut microbiome. BMC Res Notes. 2014 Apr 1;7:204. doi: 10.1186/1756-0500-7-204. PMID 24690120
- BACKGROUNDGoedert JJ, Jones G, Hua X, Xu X, Yu G, Flores R, Falk RT, Gail MH, Shi J, Ravel J, Feigelson HS. Investigation of the association between the fecal microbiota and breast cancer in postmenopausal women: a population-based case-control pilot study. J Natl Cancer Inst. 2015 Jun 1;107(8):djv147. doi: 10.1093/jnci/djv147. Print 2015 Aug. PMID 26032724