Prebiotic and Probiotic Supplement for General Health

Not currently recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Olly, PBC

Must not be taking: Probiotics, Antibiotics, Supplements, others

Disqualifiers: Severe digestive issues, Chronic conditions, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a daily prebiotic and probiotic supplement affects general health, particularly digestive comfort. Researchers will randomly assign participants to either a supplement group or a placebo group (receiving a lookalike supplement with no active ingredients). Participants will log their food intake, provide stool samples, and have blood drawn. The study seeks healthy individuals between 18 and 50 who occasionally experience mild digestive issues, such as bloating or mild discomfort, and have no diagnosed chronic digestive or immune conditions. As an unphased trial, it offers participants the opportunity to contribute to scientific understanding of digestive health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications and dietary supplements to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the safety of probiotics and prebiotics, like those in the supplement under study, remains not fully understood. The U.S. Food and Drug Administration (FDA) does not regulate these supplements as strictly as medicines, allowing them to be sold with less safety testing.

Some studies have identified safety concerns, particularly with long-term use. In certain cases, probiotics have caused serious infections in vulnerable groups, such as premature babies. Additionally, prolonged use might increase inflammation in the body, which is undesirable.

While many people use these supplements without issues, the lack of strict regulation and comprehensive studies suggests potential risks. Prospective trial participants should consider these points and discuss them with a healthcare professional. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dietary supplement with actives because it combines both prebiotics and probiotics to potentially improve overall health. Unlike typical supplements that may focus solely on either prebiotics or probiotics, this treatment offers a comprehensive approach by including both, which could enhance gut health more effectively. Additionally, the supplement is conveniently administered as a once-daily gummy, making it easy to incorporate into daily routines without the need for water or food. This user-friendly delivery method could encourage better adherence and, consequently, more consistent health benefits.

What evidence suggests that this dietary supplement could be effective for general health?

This trial will compare a dietary supplement containing active prebiotics and probiotics to a placebo. Research has shown that probiotics and prebiotics can improve overall health by supporting beneficial gut bacteria. Studies have found that probiotics aid digestion and may prevent certain infections, such as those in the stomach and lungs. They might also help with food allergies and dental health. While these areas appear promising, researchers are still learning about their effects on general health. Overall, these supplements are believed to boost the immune system and support better digestion. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who are willing to take a dietary supplement or placebo, keep a daily food log, provide stool samples and blood draws, and complete certain health questionnaires.

Inclusion Criteria

I agree not to take any supplements or medications during the study.

I agree to give blood samples and collect stool samples as directed.

Subject has signed a written Informed Consent and is willing and able to attend all visits and comply with study instructions

Exclusion Criteria

I am on medication for a long-term health condition.

Subject is pregnant, nursing, or planning to become pregnant

I am currently taking probiotics or consuming probiotic-rich foods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the active dietary supplement or placebo in a crossover design, with daily food logs, stool samples, blood draws, and validated questionnaires

10 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Supplement with actives

Trial Overview

The study tests the effects of a prebiotic and probiotic supplement compared to a placebo. It's designed as a randomized, crossover trial where participants will switch between treatments.

How Is the Trial Designed?

Group I: Dietary Supplement with actives Active Control 1 Intervention

Oral dietary supplement. Instructions: Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.

Group II: Placebo Placebo Group 1 Intervention

Oral dietary supplement. Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.

Who Is Running the Clinical Trial?

Olly, PBC

Lead Sponsor

Trials

4

Recruited

260+

Published Research Related to This Trial

Pre- and probiotics have shown promising effects on gut health by maintaining a healthy gut microflora and influencing metabolic and immune mechanisms, but scientific proof of their benefits in humans is still lacking.

Certain clinical conditions, such as ulcerative colitis and antibiotic-induced diarrhea, have demonstrated therapeutic benefits from pre- and probiotics, suggesting potential for broader applications in gut health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pre- and probiotics]. Meier, R., Lochs, H.[2015]

Probiotics are beneficial microbial supplements that help improve gut health by balancing intestinal bacteria, and they can be effective in treating conditions like lactose intolerance and various types of diarrhea, including those caused by antibiotics and infections.

Clinical studies indicate that probiotics may also enhance immune function, prevent allergic diseases, and help manage inflammatory bowel diseases, suggesting their potential role in overall health and disease prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Probiotics--an alternative for antibiotics?]. Trafalska, E., Grzybowska, K.[2015]

Pre- and probiotics can positively change the gut microbiome, which may enhance the host's health by improving immune function and lipid metabolism, as well as potentially preventing certain diseases like cancer.

The review highlights both supportive and opposing evidence regarding the effectiveness of pre- and probiotics in treating various conditions, including diarrhea, Helicobacter pylori infections, and inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional impact of pre- and probiotics as protective gastrointestinal organisms. Teitelbaum, JE., Walker, WA.[2006]

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]

A systematic review of 11 studies found that probiotic and prebiotic supplementation during pregnancy and lactation is generally safe, with only minor adverse effects reported.

The most notable adverse effect was an increased risk of vaginal discharge and changes in stool consistency associated with specific strains, but these do not pose serious health concerns for mothers or infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Probiotics and Prebiotics Safe for Use during Pregnancy and Lactation? A Systematic Review and Meta-Analysis. Sheyholislami, H., Connor, KL.[2021]

Current evidence suggests that probiotic- and/or prebiotic-supplemented infant formulae do not raise safety concerns regarding growth or adverse effects in healthy infants, based on a systematic review of existing studies.

However, there is insufficient data to recommend routine use of these supplemented formulae, highlighting the need for well-designed randomized controlled trials to better understand their long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. Braegger, C., Chmielewska, A., Decsi, T., et al.[2022]

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]

Prebiotics and probiotics can work together, known as synbiotics, to reduce cancer processes, particularly in the colon, which is a major health concern in aging populations.

The SYNCAN project aims to explore how synbiotics and prebiotics can be incorporated into food products without negatively affecting taste or quality, potentially enhancing our diets with beneficial nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation in human volunteers of the potential anticarcinogenic activities of novel nutritional concepts: prebiotics, probiotics and synbiotics (the SYNCAN project QLK1-1999-00346). Van Loo, J., Jonkers, N.[2007]

Probiotics have been shown to effectively prevent and manage both gastrointestinal and non-gastrointestinal conditions by interacting with gut-associated lymphoid tissue (GALT) and modulating the immune response.

Recent human clinical trials suggest that prebiotics may also provide clinical benefits as dietary supplements, potentially offering new nutritional strategies for managing various gastrointestinal and systemic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human studies with probiotics and prebiotics: clinical implications. Saavedra, JM., Tschernia, A.[2017]

In a clinical trial with 84 patients suffering from irritable bowel syndrome (IBS), a novel probiotic combination (I.31) significantly improved IBS-related quality of life compared to a placebo, with notable increases in scores after 6 weeks of treatment.

Both high and low doses of the probiotic led to greater improvements in gut-specific anxiety and quality of life, with no reported adverse effects, indicating that I.31 is a safe and effective option for managing IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life. Lorenzo-Zúñiga, V., Llop, E., Suárez, C., et al.[2022]

Probiotics can have both benefits and potential adverse effects, especially as their use expands into vulnerable populations, highlighting the need for careful monitoring and recommendations for safe use.

The International Scientific Association for Probiotics and Prebiotics emphasizes the importance of whole genome sequencing to assess the safety of probiotic strains, including their virulence and antibiotic resistance, to ensure product quality and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging issues in probiotic safety: 2023 perspectives. Merenstein, D., Pot, B., Leyer, G., et al.[2023]

Prebiotics, which are non-digestible carbohydrates, have various health benefits for both humans and animals, including positive effects on the gastrointestinal tract, cardiometabolism, and mental health.

There is a significant regulatory challenge regarding prebiotics, as clear definitions and classifications are needed to help consumers and manufacturers understand their benefits and applications, especially for emerging and non-established prebiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel and emerging prebiotics: Advances and opportunities. Cardoso, BB., Amorim, C., Silvério, SC., et al.[2021]

In a trial with 15 healthy volunteers, a 4-week synbiotic intervention combining specific probiotics and chicory-derived inulin showed no adverse effects, indicating its safety for consumption.

The intervention led to an increase in the abundance of beneficial gut bacteria, particularly Bifidobacteriaceae, while the overall diversity of the gut microbiome remained unchanged, suggesting targeted effects of the synbiotics on gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synbiotic Intervention with Lactobacilli, Bifidobacteria, and Inulin in Healthy Volunteers Increases the Abundance of Bifidobacteria but Does Not Alter Microbial Diversity. Rubin, IMC., Mollerup, S., Broholm, C., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5622781/

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sciencedirect.com

sciencedirect.com/science/article/pii/S2161831324000991

Is There Evidence to Support Probiotic Use for Healthy ...

Our approach was to perform a descriptive review of efficacy evidence that probiotics can prevent urinary, vaginal, gastrointestinal, and respiratory infections ...

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mayoclinic.org

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Probiotics and prebiotics: What you should know

Research has shown promise that probiotics and prebiotics may be helpful. But it hasn't yet proved that probiotics and prebiotics improve health ...

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withpower.com

withpower.com/trial/phase-healthy-subjects-hs-1-2025-d421e

Prebiotic and Probiotic Supplement for General Health

Pre- and probiotics can positively change the gut microbiome, which may enhance the host's health by improving immune function and lipid metabolism, as well as ...

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Probiotics overview for health professionals. Research food and supplement sources, health effects, safety, selection, and use here.

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Probiotics: Usefulness and Safety | NCCIH - NIH

Cases of severe or fatal infections have been reported in premature infants who were given probiotics, and the U.S. Food and Drug Administration (FDA) has ...

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sciencedirect.com

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Addressing safety concerns of long-term probiotic use

Long-term probiotic use could lead to a gradual health deterioration. Increased inflammatory cytokines confirm the systemic pro-inflammatory response.

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wwwnc.cdc.gov/eid/article/16/11/10-0574_article

Regulatory Oversight and Safety of Probiotic Use

In contrast to drugs, dietary supplements do not need FDA approval before being marketed. However, manufacturers need to notify FDA before ...