Validation of Ingestible Capsule to Study Small Bowel
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04094558|
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Proof of Concept||Device: Ingestible capsule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of Ingestible Capsule to Study Small Bowel|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: Single Arm
Participant swallows and retrieves capsule in stool. Capsule and stool samples are analyzed for bacterial density and composition.
Device: Ingestible capsule
Participants will swallow capsule and undergo X-rays to establish transit.
- Bacterial density count [ Time Frame: same 1 day ]density count and comparison between capsule and stool sample (CFU/ml)
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): NCT04094558
|Contact: Lynn Wilsack, MSc||403 firstname.lastname@example.org|