Synbiotic Supplement for Gut Health

Overseen By Marcelo J Amar, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Must not be taking: Prebiotics, Probiotics, others

Disqualifiers: Pregnancy, Vegan, Chronic diarrhea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Participants must not be taking any medications, with a few exceptions for sporadic medication and those that do not significantly affect the gut microbiome. If you are currently on medication, you may need to stop, unless it falls under these exceptions.

Is the synbiotic supplement safe for humans?

Research shows that human milk oligosaccharides (HMOs), a key component of the synbiotic supplement, are safe and well tolerated in both infants and adults, and they help increase beneficial gut bacteria. ^{1 2 3 4 5}

How is the HMO-Based Synbiotic Supplement treatment different from other gut health treatments?

The HMO-Based Synbiotic Supplement is unique because it uses human milk oligosaccharides (HMOs), which are naturally found in breast milk and act as prebiotics to promote beneficial gut bacteria. Unlike other treatments, HMOs also enhance immune function and support brain development, making them a novel option for improving gut health. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Human Milk Oligosaccharide-Based Synbiotic Supplement for gut health?

Research shows that human milk oligosaccharides (HMOs) can increase beneficial bacteria in the gut, improve gut barrier function, and reduce inflammation, which suggests they may help with gut health. These benefits have been observed in infants and adults, indicating potential effectiveness for gut health in other age groups as well. ^{1 2 3 4 5}

Who Is on the Research Team?

Marcelo J Amar, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 who typically eat a western diet and are not on medications, with some exceptions. They should be willing to visit the clinic twice, provide blood and stool samples, complete a food diary, and consult with a nutritionist.

Inclusion Criteria

My recent lab tests are mostly within normal ranges.

Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations

I am not on any regular medications, except for a few allowed by my doctor.

Exclusion Criteria

I am taking or plan to take medications that could affect my gut health.

I am expected to undergo surgery during the study.

My weight has changed by more than 20% in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive the synbiotic supplement, Cardiosyn, for 8 weeks. They will drink 2 doses per day, each dose being 1 hour before or after a meal.

8 weeks

1 visit (in-person), additional virtual or phone consultations

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeating physical exams, blood tests, and stool sample collection.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Human Milk Oligosaccharide-Based Synbiotic Supplement

Trial Overview The study tests if Cardiosyn, a synbiotic supplement made from natural sugars found in human milk, can boost beneficial gut bacteria and improve heart health markers in healthy individuals when taken twice daily mixed in drinks.

How Is the Trial Designed?

Group I: Cardiosyn in Healthy Volunteers Experimental Treatment 1 Intervention

Participants will receive 2 doses of Cardiosyn daily by mouth (2 sachets) for a total of 16.2 grams. Each does (sachet) is 8.1 grams.

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study involving 75 children aged 6 to 12 years, supplementation with human milk oligosaccharides (HMOs) like 2'-fucosyllactose (2'FL) significantly increased beneficial bifidobacteria in the gut after 4 and 8 weeks, indicating a positive modulation of intestinal microbiota.

The trial demonstrated that both 2'FL and a mix of HMOs were safe and well tolerated, with no adverse digestive issues reported, suggesting they can be safely used to improve gut health in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Milk Oligosaccharides Modulate Fecal Microbiota and Are Safe for Use in Children With Overweight: A Randomized Controlled Trial. Fonvig, CE., Amundsen, ID., Vigsnæs, LK., et al.[2022]

Infants fed formulas supplemented with the human milk oligosaccharide 2'-fucosyllactose (2'-FL) showed significantly lower levels of inflammatory cytokines compared to those fed a control formula, indicating a potential immune-modulating effect of 2'-FL.

The immune profiles of infants receiving 2'-FL were comparable to those of breastfed infants, suggesting that 2'-FL supplementation in formula may help mimic some of the immune benefits of breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. Goehring, KC., Marriage, BJ., Oliver, JS., et al.[2023]

A new method was developed and validated to analyze six specific human milk oligosaccharides (HMOs) that are beneficial for infant health, meeting the AOAC Standard Method Performance Requirements.

This method is non-toxic, automates the removal of excess reagents, and allows for the simultaneous analysis of multiple HMOs, which is important for ensuring the quality of infant formulas and adult nutritionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Six Human Milk Oligosaccharides (HMO) in Infant Formula and Adult Nutritionals by 2AB Labeling and Quantification with HILIC-FLD: First Action 2022.02. Ellingson, DJ., Ruosch, AJ., Foster, KL., et al.[2022]

Human milk oligosaccharides (HMOs) are effective in treating and preventing gut inflammation by enhancing gut microbiota, improving gut barrier function, and reducing inflammation, making them a valuable natural probiotic.

Due to the high cost and complexity of synthesizing HMOs, there is ongoing research into alternative functional oligosaccharides that could serve as effective substitutes in infant milk powder and as adjunct therapies for chronic inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The function of human milk oligosaccharides and their substitute oligosaccharides as probiotics in gut inflammation. Zhao, K., Pang, H., Shao, K., et al.[2023]

Human milk oligosaccharides (HMOs) are important prebiotics found in human milk that support the infant's gut health and immune system, potentially leading to better responses to infections and reduced risk of chronic diseases.

Supplementation of HMOs in infant formula may provide similar benefits to those found in breastfed infants, including improved immunity and reduced risk of allergies and asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of human milk oligosaccharides on health from infancy to childhood. Fibbiani, M., Ghelli Luserna DI Rorà, L., Novelli, T., et al.[2023]

Human milk oligosaccharides (HMOs) are crucial for infant health, providing benefits such as disease protection, gut health, immune support, and brain development, making their addition to infant formula highly beneficial.

Recent advancements in biotechnological synthesis methods, particularly whole-cell biocatalysis, have improved the production of smaller HMOs, although challenges remain in synthesizing larger and more complex HMOs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Technology Development for the Biosynthesis of Human Milk Oligosaccharide. Guan, N., Chen, R.[2018]

Human milk is crucial for shaping an infant's gut microbiome and immune system, providing not just nutrition but also bioactive molecules like human milk oligosaccharides (HMOs) that support microbial health.

HMOs, which infants cannot digest, act as prebiotics in the intestines, promoting the growth of beneficial bacteria like Bifidobacterium spp. that can break them down, highlighting their important role in infant gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Untangling human milk oligosaccharides and infant gut microbiome. Masi, AC., Stewart, CJ.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Human Milk Oligosaccharides Modulate Fecal Microbiota and Are Safe for Use in Children With Overweight: A Randomized Controlled Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Analysis of Six Human Milk Oligosaccharides (HMO) in Infant Formula and Adult Nutritionals by 2AB Labeling and Quantification with HILIC-FLD: First Action 2022.02. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The function of human milk oligosaccharides and their substitute oligosaccharides as probiotics in gut inflammation. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

The impact of human milk oligosaccharides on health from infancy to childhood. [2023]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Recent Technology Development for the Biosynthesis of Human Milk Oligosaccharide. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Untangling human milk oligosaccharides and infant gut microbiome. [2021]