SuperHMO Prebiotic for Gut Health

Overseen By Kim Sukhum, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Seeding, Inc DBA Tiny Health

Must not be taking: Prebiotics, Probiotics

Disqualifiers: Pregnancy, IBD, Celiac's, HIV, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a prebiotic supplement called SuperHMO affects the gut health of healthy adults. Participants will take either SuperHMO or a placebo (a substance with no active ingredients) daily for 30 days. The trial will evaluate whether SuperHMO improves gut health by examining specific gut markers before and after the trial. Individuals who haven't used prebiotic or probiotic supplements in the last six months and don’t have any major gut or immune conditions may qualify. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on gut health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken prebiotic or probiotic supplements in the last 6 months and must not take them during the study.

What prior data suggests that the SuperHMO prebiotic is safe for gut health?

Research shows that human milk oligosaccharides (HMOs), like those in the SuperHMO prebiotic, are generally safe for people. Studies indicate that HMOs remain intact in the stomach and reach the gut, where they promote the growth of beneficial bacteria. This suggests they are well-tolerated by the body.

HMOs naturally occur in human breast milk and play a key role in developing a baby's gut health, providing a history of safety for humans. Although specific data on SuperHMO is limited, similar products have been used in clinical trials without major issues.

Overall, evidence suggests that HMOs are safe and can beneficially support gut health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SuperHMO because it utilizes five types of human milk oligosaccharides (HMOs) to improve gut health, a mechanism not commonly found in current prebiotic treatments. While most gut health supplements rely on fiber or generic prebiotics, SuperHMO specifically targets beneficial bacteria by mimicking the unique components found in human milk, which are known for their role in nurturing a healthy gut microbiome. This novel approach could potentially offer enhanced benefits in promoting a diverse and balanced gut flora compared to traditional options.

What evidence suggests that SuperHMO might be an effective treatment for gut health?

Studies have shown that prebiotics, like those in SuperHMO, can promote the growth of beneficial gut bacteria. A healthy gut is linked to improved digestion and overall health. SuperHMO, which participants in this trial may receive, contains five types of special sugars found in human milk, known as human milk oligosaccharides (HMOs). These sugars help beneficial bacteria grow and thrive. Early research suggests that these sugars can enhance gut health by increasing the number and variety of helpful bacteria. Studies also indicate that this increase in good bacteria might support digestion and brain health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in participating in a study to evaluate the effects of a prebiotic supplement on gut health. Participants will be required to take a daily supplement or placebo and undergo gut health testing before and after the 30-day period.

Exclusion Criteria

Participants must not be pregnant or breastfeeding or trying to conceive within the study period.

I haven't received at-home stool test results in the last 6 months.

I do not have any pre-existing gut conditions like IBD, Celiac's, Crohn's disease, or SIBO.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the SuperHMO prebiotic formulation or placebo daily for 30 days

4 weeks

Baseline visit for initial survey and microbiome sample, exit visit for final survey and microbiome sample

Follow-up

Participants are monitored for changes in gut microbiome diversity and health markers after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SuperHMO

Trial Overview The study is testing Layer Origin's SuperHMO prebiotic formulation against a placebo (non-GMO corn Maltodextrin). The main goal is to see if SuperHMO improves gut microbiome health, specifically its ability to produce beneficial short-chain fatty acids over 30 days.

How Is the Trial Designed?

Group I: Intervention - SuperHMO Experimental Treatment 1 Intervention

The investigation product is commercially available and is marketed as SuperHMO Prebiotic Mix with 5 HMOs. This product is a dietary supplement which contains five major types of human milk oligosaccharides includes 2'-Fucosyllactose (2'-FL), Lacto-N-tetraose (LNT), Lacto-N-neotetraose (LNnT), 6'-Sialyllactose (6'SL), and 3'-Sialyllactose (3'SL). SuperHMO is designed to boost the number and variety of beneficial bacteria in the gut by feeding them with five different kinds of human milk oligosaccharide prebiotics. This product does not contain any flavoring, colorants, preservatives or fillers. Each bottle contains 118 grams of the mix, 28 servings, with 4.2 grams per serving (2 scoops). Study participants will be instructed to take 1 scoop (2.1 g) per day for the first five days and increase to 2 scoops (4.2g) per day for days 6-30, the formulation can be dissolved in their beverage of choice and taken at any time of the day, with or without food.

Group II: Control Placebo Group 1 Intervention

Control participants will receive a commercially available maltodextrin, NOW Sports Nutrition, Non-GMO corn Maltodextrin, Rapid Absorption. The composition and absorption properties are similar to the investigational product and will be given in the same dosage (2.1g/day for days 1-5 and increasing to 4.2 g/day for days 6-30) and route of administration as the investigational product. The use of maltodextrin as a comparator in prebiotic supplementation in human trials is well-documented.

Who Is Running the Clinical Trial?

Seeding, Inc DBA Tiny Health

Lead Sponsor

Trials

2

Recruited

130+

Mellitas Health Foods, LLC (DBA Layer Origin Nutrition)

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Probiotics and prebiotics have been traditionally consumed for their health benefits, particularly for gut health, and there is growing scientific interest in the gut microbiota's role in health and disease.

While some human diseases, such as diarrheal illnesses and inflammatory bowel diseases, may benefit from probiotics, there is still a lack of extensive clinical evidence supporting their use, especially for prebiotics, which have not been widely tested in large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics and probiotics: their role in the management of gastrointestinal disorders in adults. Quigley, EM.[2022]

In a study using fecal cultures from healthy and morbidly obese adults, different prebiotics were tested, revealing that 1-kestose had the most significant impact on gut microbiota composition and metabolic activity.

Prebiotic modulation led to increased Bacteroides and Faecalibacterium in obese individuals, while normal-weight individuals showed higher levels of Bifidobacterium and Faecalibacterium, highlighting the need for tailored prebiotic treatments based on individual microbiota profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Evaluation of Different Prebiotics on the Modulation of Gut Microbiota Composition and Function in Morbid Obese and Normal-Weight Subjects. Nogacka, AM., Salazar, N., Arboleya, S., et al.[2023]

Prebiotics, particularly inulin-type fructans, are non-digestible ingredients that can selectively promote the growth of beneficial gut bacteria, which may improve health outcomes.

To truly understand the prebiotic effects, it's essential to study their impact on the entire gut microbiota in human subjects, rather than just focusing on individual bacteria in isolation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics: preferential substrates for specific germs? Roberfroid, MB.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06570330

Adult HMO Supplementation and the Gut Microbiome The goal of this study is to assess the impact of Layer Origin's SuperHMO prebiotic formulation on the healthy adult gut microbiome.

2. withpower.com withpower.com/trial/phase-healthy-adults-8-2024-f5e8b

SuperHMO Prebiotic for Gut Health · Info for Participants Research shows that prebiotics, like those in SuperHMO, can help promote the growth of beneficial gut bacteria, which may improve gut health. Some studies ...

3. layerorigin.com layerorigin.com/pages/superhmo-clinical-study?srsltid=AfmBOop4dYWV1XXXTfMUHStdOTh0dwheIJPYVY_-L4xztxrSYVP_i4Wg

SuperHMO Clinical Study The study assesses SuperHMO's impact on the gut microbiome in 24 adults over 30 days, with daily supplementation and microbiome testing.

4. amazon.com amazon.com/Layer-Origin-SuperHMO-Prebiotic-HMOs/dp/B0BT66RCM3

Layer Origin SuperHMO Prebiotic Mix with 5-HMO ... This prebiotic mix contains 5 HMOs, promoting gut health, digestion, and brain health by boosting beneficial bacteria and supporting cognitive development.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7551690/

Effects of Human Milk Oligosaccharides on the Adult Gut ... Human milk oligosaccharides (HMOs) shape the gut microbiota in infants by selectively stimulating the growth of bifidobacteria.

6. nature.com nature.com/articles/s41598-023-41040-5

Human milk oligosaccharides modulate the intestinal ... Human milk contains over 200 distinct oligosaccharides, which are critical to shaping the developing neonatal gut microbiome.

7. sciencedirect.com sciencedirect.com/science/article/pii/S187595722200273X

Review Article Human milk oligosaccharides as prebiotics HMOs are considered prebiotics because they resist acidic pH and enzymatic degradation and reach the large intestine intact to support microbial growth.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7332462/

Human milk oligosaccharides: Shaping the infant gut ... HMOs serve as prebiotic components supplying metabolic substrates necessary for beneficial bacteria to thrive (Bode, 2009, Gibson et al., 2017).

9. amazon.com amazon.com/Layer-Origin-PureHMO-Super-Prebiotic/dp/B08667FSG5

Layer Origin PureHMO Human Milk Oligosaccharide (HMO ... Pure, effective, and clinically-proven, PureHMO super prebiotic can help us build a robust gut to support every layer of our health.

10. cell.com cell.com/cell-reports-medicine/fulltext/S2666-3791(25)00329-5

A human milk oligosaccharide alters the microbiome ... A randomized, placebo-controlled clinical trial to study the effects of 2′-FL on the microbiota and host immune system. We performed the RAMP Study ( ...