Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615986
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09-27
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Human intestines are home to a complex gut flora also called microbiome this is a natural occurring community of bacteria fungi yeast and viruses Changes in the balances of the gut flora can lead to illnesses such as diabetes colorectal cancer and inflammatory bowel diseases Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health
Objective
To find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers The supplement contains a natural sugar from human milk
Eligibility
Healthy people aged 18 years or older who eat a typical western diet They must take no medications with a few exceptions
Design
Participants will have 2 clinic visits
The first visit will start with screening They will have a blood test and wait around 2 hours for the results of the blood test The test will determine if they are eligible for the study
Eligible participants will have additional blood drawn during the screening visit They will be given a kit to collect a stool sample at home with instructions They may complete a 3-day food diary They will meet with a nutritionist and a physician by phone telehealth or in person
The supplement is a powder that is mixed with water or another noncarbonated drink Participants will drink 2 doses per day Each dose will be 1 hour before or after a meal
The second visit will be about 8 weeks after the first Participants may repeat the 3-day food diary and nutrition visit The physical exam blood tests and stool sample will be repeated
Human intestines are home to a complex gut flora also called microbiome this is a natural occurring community of bacteria fungi yeast and viruses Changes in the balances of the gut flora can lead to illnesses such as diabetes colorectal cancer and inflammatory bowel diseases Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health
Objective
To find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers The supplement contains a natural sugar from human milk
Eligibility
Healthy people aged 18 years or older who eat a typical western diet They must take no medications with a few exceptions
Design
Participants will have 2 clinic visits
The first visit will start with screening They will have a blood test and wait around 2 hours for the results of the blood test The test will determine if they are eligible for the study
Eligible participants will have additional blood drawn during the screening visit They will be given a kit to collect a stool sample at home with instructions They may complete a 3-day food diary They will meet with a nutritionist and a physician by phone telehealth or in person
The supplement is a powder that is mixed with water or another noncarbonated drink Participants will drink 2 doses per day Each dose will be 1 hour before or after a meal
The second visit will be about 8 weeks after the first Participants may repeat the 3-day food diary and nutrition visit The physical exam blood tests and stool sample will be repeated
Detailed Description:
Study Description
This pilot proof-of-principle PoP study will investigate mechanisms of action of a human milk oligosaccharide HMO-based synbiotic supplement Cardiosyn a combination of prebiotics and pro-biotics Synbiotics for gut microbiota are known to exert multiple beneficial effects including anti-inflammatory and antioxidant actions and normalizing blood lipids and iron markers in healthy human subjects
Objectives
Primary Objective
To measure changes in microbiome determined by the increase of the population of Lactobacillus Plantarum and Bifidobacterium Bifidum
Secondary Objectives
Measure the level of adherence to the symbiotic supplementation
Measure the effect of the synbiotic supplementation in plasma
Measure the effect of synbiotic supplementation on gut integrity
Tolerability and GI symptoms secondary to gut microbiome changes
TertiaryExploratory Objectives
Identify possible associations between the gut microbiome change and biomarkers
Endpoints Primary Endpoint
At least an increase of two-fold in the population of Lactobacillus Plantarum and Bifidobacterium Bifidum
Secondary Endpoint
Reported intake by the subject and counting the number of the remaining supplement
Biomarkers such as serum and fecal calprotectin hs-CRP serum iron hepcidin hemoglobin lipid profile and TMAO
Measurement of gut integrity marker serum zonulin in plasma
Number of participants that tolerated study supplement for full duration of study
Number of participants with GI reported symptoms according to CTCAE v50
TertiaryExploratory Endpoints
Measurement of changes of microbiome and biomarkers in plasma 16S RNA microbiota analysis initially with potential for more extensive and novel analysis
This pilot proof-of-principle PoP study will investigate mechanisms of action of a human milk oligosaccharide HMO-based synbiotic supplement Cardiosyn a combination of prebiotics and pro-biotics Synbiotics for gut microbiota are known to exert multiple beneficial effects including anti-inflammatory and antioxidant actions and normalizing blood lipids and iron markers in healthy human subjects
Objectives
Primary Objective
To measure changes in microbiome determined by the increase of the population of Lactobacillus Plantarum and Bifidobacterium Bifidum
Secondary Objectives
Measure the level of adherence to the symbiotic supplementation
Measure the effect of the synbiotic supplementation in plasma
Measure the effect of synbiotic supplementation on gut integrity
Tolerability and GI symptoms secondary to gut microbiome changes
TertiaryExploratory Objectives
Identify possible associations between the gut microbiome change and biomarkers
Endpoints Primary Endpoint
At least an increase of two-fold in the population of Lactobacillus Plantarum and Bifidobacterium Bifidum
Secondary Endpoint
Reported intake by the subject and counting the number of the remaining supplement
Biomarkers such as serum and fecal calprotectin hs-CRP serum iron hepcidin hemoglobin lipid profile and TMAO
Measurement of gut integrity marker serum zonulin in plasma
Number of participants that tolerated study supplement for full duration of study
Number of participants with GI reported symptoms according to CTCAE v50
TertiaryExploratory Endpoints
Measurement of changes of microbiome and biomarkers in plasma 16S RNA microbiota analysis initially with potential for more extensive and novel analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None