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?

This trial aims to determine if a synbiotic supplement containing a natural sugar from human milk can enhance good gut bacteria and improve heart health markers in healthy individuals. Participants will take the Human Milk Oligosaccharide-Based Synbiotic Supplement twice daily for about eight weeks. It suits healthy individuals who consume a typical Western diet and are not taking medications that could affect the gut. As an Early Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this innovative supplement.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that supplements with human milk oligosaccharides (HMOs) are generally safe and well-tolerated. Studies have found that these supplements can offer several benefits, such as reducing inflammation and maintaining healthy cholesterol levels. HMOs have been safely used in infants, suggesting they are likely safe for adults as well. In these studies, participants did not report any serious side effects, underscoring the supplement's strong safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for gut health that often involve probiotics alone, the synbiotic supplement being studied is unique because it combines human milk oligosaccharides (HMOs) with beneficial bacteria. HMOs are special sugars found in human breast milk that help nourish good gut bacteria and support the immune system. Researchers are excited about this treatment because it has the potential to enhance gut health more effectively by not only introducing good bacteria but also providing the fuel they need to thrive. This dual-action approach could offer more comprehensive support for gut health compared to existing options.

What evidence suggests that this synbiotic supplement could be effective for gut health?

Research has shown that certain ingredients in the Human Milk Oligosaccharide-Based Synbiotic Supplement, similar to those in human milk, can help treat and prevent gut inflammation. These ingredients support healthy intestinal bacteria and strengthen the gut's protective barrier. Studies have found that these supplements can reduce inflammation and act as antioxidants, potentially helping to balance blood fats. This suggests that the supplement could increase the number and variety of beneficial gut bacteria and improve heart health indicators. Although human data remains limited, these early results are promising for those considering participation in clinical trials. ^{1 4 6 7 8}

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

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

My recent lab tests are mostly within normal ranges.

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.

Subjects planning a significant change in diet or exercise levels

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

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]

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06615986?draw=2&rank=1

Human Milk Oligosaccharide-Based Synbiotic Supplement ... Synbiotics for gut microbiota are known to exert multiple beneficial effects, including anti-inflammatory and antioxidant actions, and normalizing blood lipids ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10458772/

Clinical Studies on the Supplementation of Manufactured ... In this systematic review, we evaluate the health outcomes of published clinical trials involving the supplementation of manufactured HMOs.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06615986/human-milk-oligosaccharide-based-synbiotic-supplement-for-intestinal-microbiota-dysbiosis

Human Milk Oligosaccharide-Based Synbiotic Supplement ... This pilot proof-of-principle (PoP) study will investigate mechanisms of action of a human milk oligosaccharide (HMO)-based synbiotic supplement ...

4. withpower.com withpower.com/trial/early-phase-1-dysbiosis-9-2024-29fa2

Synbiotic Supplement for Gut Health Human milk oligosaccharides (HMOs) are effective in treating and preventing gut inflammation by enhancing gut microbiota, improving gut barrier function, and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0261561425001505

Systematic review and meta-analysis of randomized ... Pre- and synbiotics may help protect against respiratory tract infection, though they do not appear to offer the same benefit for preventing diarrheal episodes.

6. amazon.com amazon.com/Layer-Origin-SuperHMO-Prebiotics-Probiotics/dp/B0DC5ZJ11C

Layer Origin SuperHMO: Synbiotic Capsules with 5 HMO ... Synbiotic Capsules: HMO prebiotic and probiotic to promote gut diversity and seed your gut with good probiotics; Probiotic Strains: 10 clinically validated ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666379125003295

A human milk oligosaccharide alters the microbiome ... Clinical and pre-clinical studies suggest that HMOs have pleiotropic benefits for the host that include fostering a healthy infant gut ...

8. layerorigin.com layerorigin.com/?srsltid=AfmBOoqMDgj9KG5EhN4kUp_pB1FuR7c3a0A29Tt-4wzBlVUylbcUORfs

Layer Origin Nutrition: PureHMO Human Milk ... HMO prebiotics feed and boost beneficial gut bacteria such as Bifidobacteria and Akkermansia et al., helping to cultivate a balanced gut microbiome.