Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-01 @ 10:01 PM
Study NCT ID:
NCT05601635
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2022-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ButyraGen™, Short Chain Fatty Acids and Gut Microbiome
Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Organization:
Study Overview
Official Title:
A Pilot Study to Demonstrate Butyrate Generation in Stool in Response to Oral Administration of ButyraGen™ in Healthy Human Subjects
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BG
Brief Summary:
This study is being conducted to demonstrate short chain fatty acid (SCFA), specifically butyrate, generation in stool, blood and urine in response to oral intake of ButyraGen™.
Detailed Description:
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This is a single-center study will follow a randomized, single-blinded parallel design with two doses. It features a 1-week intake of control followed by 3 weeks of either low dose (200 mg ButyraGen, containing 100 mg tributyrin) or high dose (400 mg, containing 200 mg tributyrin) of intervention to evaluate the effects of the active ingredient tributyrin after chronic intake in generally healthy individuals.
A planned sample size of 24 will be enrolled in the study. This study will require one initial screening visit, a pre-study visit, and 6 study day visits. The study will last about 5 weeks to complete all study procedures for each participant.
The initial screening visit will provide subjects with their site-specific, IRB approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), fasting blood sample screened for complete blood count (CBC) and basic metabolic panel (BMP), and surveys related to general eating, health, mood and exercise habits.
Subjects will be randomized to 1 of 2 interventions: low dose (100 mg - tributyrin) or high does (200 mg - tributyrin). All subjects will receive 1 week of control (0 mg - tributyrin), then same treatment (low or high dose) for the remaining duration of the study. Treatment codes will be maintained by the principal investigator. Two of the 6 study days (first and last) will last \~7 hours and include a lactulose-mannitol test. In general, this test will ask you to collect your 1st urine of the day, drink a sugary beverage and collect all urine for the next 6 hours after the drink. The other 4 study days will last \~2 hours. Subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected via a butterfly needle by a certified phlebotomist.
This is a single-center study will follow a randomized, single-blinded parallel design with two doses. It features a 1-week intake of control followed by 3 weeks of either low dose (200 mg ButyraGen, containing 100 mg tributyrin) or high dose (400 mg, containing 200 mg tributyrin) of intervention to evaluate the effects of the active ingredient tributyrin after chronic intake in generally healthy individuals.
A planned sample size of 24 will be enrolled in the study. This study will require one initial screening visit, a pre-study visit, and 6 study day visits. The study will last about 5 weeks to complete all study procedures for each participant.
The initial screening visit will provide subjects with their site-specific, IRB approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), fasting blood sample screened for complete blood count (CBC) and basic metabolic panel (BMP), and surveys related to general eating, health, mood and exercise habits.
Subjects will be randomized to 1 of 2 interventions: low dose (100 mg - tributyrin) or high does (200 mg - tributyrin). All subjects will receive 1 week of control (0 mg - tributyrin), then same treatment (low or high dose) for the remaining duration of the study. Treatment codes will be maintained by the principal investigator. Two of the 6 study days (first and last) will last \~7 hours and include a lactulose-mannitol test. In general, this test will ask you to collect your 1st urine of the day, drink a sugary beverage and collect all urine for the next 6 hours after the drink. The other 4 study days will last \~2 hours. Subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected via a butterfly needle by a certified phlebotomist.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: