Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419231
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
Effectiveness of a Butyrate Formulation and Butyrate Polyphenol Formulation on Gut Health Permeability and Associated Symptoms
Sponsor:
Supplement Formulators Inc
Organization:
Supplement Formulators Inc
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Study to Evaluate the Effects of a Butyrate Formulation and a Butyrate Polyphenol Formulation on Gut Health Permeability and Associated Symptoms
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate Polyphenol formulation on gut health permeability and associated symptoms
Detailed Description:
This is a double-blind randomized placebo-controlled remote design study to evaluate the effects of a Butyrate formulation and Butyrate Polyphenol formulation on gut health intestinal permeability and associated symptoms
Participants will be asked to complete laboratory assessments and questionnaires A total of up to 105 subjects 35 subjects per arm will be enrolled in a randomly assigned sequence for the 28-day period There will be three scheduled remote videoconferencing visits with two scheduled telephone contacts The study subjects will complete assessment tools that include the Gastrointestinal Symptoms Rating Scale for IBS GSRS-IBS Digestion-Associated Quality of Life Questionnaire DQLQ Visual Abdominal Scale of Abdominal Pain Bristol Stool Form BSFS Gastrointestinal-Global Assessment of Improvement Gastrointestinal-GAI and the Short Form-36 Health Survey SF-36 Laboratory testing will include Gut Microbiome Short Chain Fatty Acid Analysis Gut Barrier Panel and Intestinal Permeability
Participants will be asked to complete laboratory assessments and questionnaires A total of up to 105 subjects 35 subjects per arm will be enrolled in a randomly assigned sequence for the 28-day period There will be three scheduled remote videoconferencing visits with two scheduled telephone contacts The study subjects will complete assessment tools that include the Gastrointestinal Symptoms Rating Scale for IBS GSRS-IBS Digestion-Associated Quality of Life Questionnaire DQLQ Visual Abdominal Scale of Abdominal Pain Bristol Stool Form BSFS Gastrointestinal-Global Assessment of Improvement Gastrointestinal-GAI and the Short Form-36 Health Survey SF-36 Laboratory testing will include Gut Microbiome Short Chain Fatty Acid Analysis Gut Barrier Panel and Intestinal Permeability
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?:
None