Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06419231
Study type Interventional
Source Supplement Formulators, Inc.
Contact Steven Hirsh, RPh, DPM
Phone 954-202-7679
Email shirsh@lifeextension.com
Status Recruiting
Phase N/A
Start date October 31, 2023
Completion date February 21, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05931471 - Yogurt and GI Health N/A
Recruiting NCT06122571 - A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health N/A
Completed NCT05364437 - Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort N/A
Recruiting NCT06159088 - Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula N/A
Recruiting NCT06404749 - Fungal Fiber for Gut Health N/A
Not yet recruiting NCT06433310 - Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study Early Phase 1
Completed NCT00696098 - Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission N/A
Completed NCT03842514 - Food Additives - Do Processed Diets Impact on Gut and Metabolic Health N/A
Completed NCT01656499 - Effect of AXOS on the Colon Metabolism in Healthy Volunteers Phase 2
Completed NCT02440503 - How Infant Diets Would Affect Growth in Early Childhood N/A
Not yet recruiting NCT06396728 - Use of GI BIOTICS 100B UFC to Improve Intestinal Health in Older Adults N/A
Active, not recruiting NCT06023082 - A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management N/A
Completed NCT05051501 - The Effects of Microbiological Spectrum Changes to Improve Cognitive Health in Aging Population Phase 2
Completed NCT05876845 - A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health N/A
Completed NCT05488886 - Bioavailability of Aronia Berry Polyphenols N/A
Recruiting NCT04195425 - Breastfeeding and Gut Health
Completed NCT05952232 - A Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut. N/A
Recruiting NCT03624569 - Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome N/A
Recruiting NCT05809466 - The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults N/A
Completed NCT05837754 - A Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults N/A