Microbiome of Donor Iron Deficient Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02990988|
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2016
Last Update Posted : March 11, 2020
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Microbiome of Donor Iron Deficient Study (DIDS)|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Subjects participating in the associated study under the Iron Repletion arm will also provide stool collection and answers to questionnaire and diet diary.
Subjects participating in the associated study under the Placebo arm will also provide stool collection and answers to questionnaire and diet diary.
- Change in overall diversity of fecal flora [ Time Frame: Baseline, 5-days, 4-weeks, 5 months ]Stool samples will be collected and processed.
- Mean Bray-Curtis indices [ Time Frame: Baseline, 5-days, 4-weeks, 5 months ]Calculation of Bray-Curtis index will determine the relative abundance of specific taxa (e.g., Firmicutes, Bacteroidetes, Proteobacteria) for each subject. Means (of the differences in %) and standard deviations will be calculated for all comparisons, and a multivariable generalized estimating equations (GEE) model will be used to test for significance.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990988
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10023|
|Principal Investigator:||Eldad Hod, MD||Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology|