Synbiotic+ for Gastrointestinal Disorders

(SYN Trial)

Overseen By Jenny Whittington, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Colorado State University

Must not be taking: Statins, Metformin, NSAIDs, MAO inhibitors

Disqualifiers: Cancer, Liver disease, Kidney disease, others

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new supplement, Synbiotic+, can affect gut health, mood, and behavior. Researchers aim to determine if daily intake of Synbiotic+ can improve bowel movements, reduce gut inflammation, and enhance immune health. The trial includes two groups: one receiving the actual supplement and another receiving a placebo (a harmless pill with no active ingredients). Women with moderate digestive issues who are not on certain medications may qualify.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on gut health and potentially experience personal health benefits.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that current medications will be assessed individually. If your medications could affect the study's results, you might be excluded from participating.

What prior data suggests that Synbiotic+ is safe for gastrointestinal health?

Research has shown that Synbiotic+, which contains a mix of prebiotics, probiotics, and postbiotics, is generally safe for use. Studies have found that similar supplements can improve gut health by increasing beneficial bacteria like Lactobacillus, indicating a positive safety profile.

Previous research has examined synbiotics in various groups, including very young children, and did not find any serious side effects. Most people tolerate them well, with any side effects usually being mild, such as slight stomach upset.

In another study, all participants initially experienced some stomach or intestinal symptoms, but these were manageable. This suggests that while some discomfort might occur, it is usually not severe.

Overall, the evidence suggests that Synbiotic+ is well-tolerated with minimal risk, making it a promising choice for those seeking to support their gut health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for gastrointestinal disorders focus on managing symptoms with medications like antacids, H2 blockers, or proton pump inhibitors. However, Synbiotic+ is unique because it combines prebiotics, probiotics, and postbiotics in one supplement, aiming to restore and maintain a healthy gut microbiome. This approach not only targets symptoms but potentially addresses underlying imbalances in gut bacteria, offering a more holistic option. Researchers are excited about Synbiotic+ because it could provide a natural, side-effect-free alternative to conventional treatments, potentially improving long-term gut health in a way that existing medications do not.

What evidence suggests that Synbiotic+ might be an effective treatment for gastrointestinal disorders?

Research has shown that synbiotics, such as Synbiotic+, can improve gut health by supporting beneficial bacteria in the stomach. Studies have found that synbiotics ease symptoms for individuals with chronic stomach issues. One study demonstrated clear improvements in gut health compared to a group that did not take synbiotics. Additionally, taking synbiotics has increased levels of beneficial bacteria in the gut, which can help reduce inflammation. Overall, these findings suggest that Synbiotic+ could effectively manage stomach problems and enhance gut health. Participants in this trial will be assigned to either a treatment group receiving the Synbiotic+ supplement or a control group receiving a placebo. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women experiencing gastrointestinal issues or benign liver and biliary diseases. Participants should be interested in how dietary supplements might affect their gut health, mood, and behavior.

Inclusion Criteria

I am willing to follow the study rules and go to all clinic visits.

I am a healthy woman aged between 25 and 65.

BMI <30

Exclusion Criteria

BMI >30

I am under 25 or over 65 years old.

Pregnant and breastfeeding individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline and Lead-in

Participants undergo baseline assessments and a 7-day lead-in period before starting treatment

1 week

1 visit (in-person)

Treatment

Participants take the assigned treatment (probiotic supplement or placebo) for 12 weeks

12 weeks

3 visits (in-person) at baseline, mid-point, and final

Acute Study Visit

Participants return a stool sample to assess acute effects of the treatment

3 days after treatment start

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Synbiotic+

Trial Overview The study tests Synbiotic+, a supplement with prebiotics, probiotics, and postbiotics. It looks at its effect on bowel movements, GI symptoms, gut microbes, inflammation markers in stool/blood, immune health, stress levels, sleep quality & overall life satisfaction.

How Is the Trial Designed?

Group I: Treatment Group (probiotic supplement) Experimental Treatment 1 Intervention

This group will take a once daily supplement containing pre-pro-post biotics.

Group II: Control Placebo Group 1 Intervention

This group will be taking a once daily placebo pill.

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

Ritual Vitamin Company

Collaborator

Trials

1

Recruited

60+

Ritual

Collaborator

Published Research Related to This Trial

In a randomized, double-blind, placebo-controlled study involving healthy adults, daily consumption of the probiotic combination SYNBIO® significantly improved bowel habits compared to the control group.

The study also confirmed that the probiotic strains persisted in the gastrointestinal tract, indicating their potential for long-term benefits in bowel health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic-enriched foods and dietary supplement containing SYNBIO positively affects bowel habits in healthy adults: an assessment using standard statistical analysis and Support Vector Machines. Silvi, S., Verdenelli, MC., Cecchini, C., et al.[2022]

A study involving 100 chronically constipated women showed that a synbiotic supplement (LACTOFOS®) significantly improved stool frequency and consistency compared to a placebo over 30 days.

The synbiotic treatment led to better constipation intensity scores, indicating its efficacy in managing constipation, while not affecting abdominal symptoms like pain or bloating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of synbiotic in constipated adult women - a randomized, double-blind, placebo-controlled study of clinical response. Waitzberg, DL., Logullo, LC., Bittencourt, AF., et al.[2022]

A randomized trial showed that a novel synbiotic drink, containing bifidobacteria and Fucus evanescens polysaccharides, significantly improved symptoms and recovery of intestinal microflora in patients with chronic gastrointestinal diseases compared to standard treatments.

Patients receiving the synbiotic drink had a higher cure rate than those undergoing routine therapy or treatment with sour milk bifidobacterin, indicating its potential as an effective therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency of a new synbiotic drink in treatment of chronic diseases of gastrointestinal tract and concomitant dysbacteriosis]. Kuznetsova, TA., Zaporozhets, TS., Besedova, NN., et al.[2016]

In a study of 75 patients who underwent colectomy, those who received synbiotics showed significantly improved gastrointestinal quality of life scores compared to those on a placebo at 1, 3, and 6 months post-surgery.

The use of synbiotics also led to a reduction in diarrhea symptoms over time, indicating a positive impact on gastrointestinal function after surgery, while no significant effects were observed for constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synbiotics and gastrointestinal function-related quality of life after elective colorectal cancer resection. Theodoropoulos, GE., Memos, NA., Peitsidou, K., et al.[2020]

A systematic review of 57 clinical studies found that probiotics and synbiotics are safe for immune-compromised adults, with no serious adverse events linked to these products, indicating they are well tolerated.

Probiotics and synbiotics resulted in fewer adverse events compared to control groups, but the study highlighted issues with inconsistent reporting of adverse events, suggesting a need for standardized reporting to enhance data reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The administration of probiotics and synbiotics in immune compromised adults: is it safe? Van den Nieuwboer, M., Brummer, RJ., Guarner, F., et al.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06834984

Study Details | NCT06834984 | Ritual Synbiotic+, a Dietary ... Secondary outcomes will include stool and blood markers of gut barrier function and intestinal inflammation, immune health, and self-assessments of stress ...

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

Effects of Probiotics, Prebiotics, and Synbiotics on Human ... Results of clinical studies confirm the positive effect of probiotics on gastrointestinal diseases (e.g., irritable bowel syndrome, gastrointestinal disorders, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213434424000288

The synbiotic solution: Evaluating safety and efficacy in ... The Synbiotic supplement demonstrated significant positive outcomes across diverse parameters. Compared to the disease control group, the Synbiotic group ...

4. withpower.com withpower.com/trial/phase-gastrointestinal-diseases-2-2025-7da64

Synbiotic+ for Gastrointestinal Disorders (SYN Trial) Studies have found that synbiotics help maintain healthy gut bacteria and reduce symptoms in people with chronic gastrointestinal issues. Show more ...

5. bmcmicrobiol.biomedcentral.com bmcmicrobiol.biomedcentral.com/articles/10.1186/s12866-025-03953-1

Synbiotic-driven modulation of the gut microbiota and ... Synbiotic supplementation increased anaerobic bacterial counts by 2.6 log CFU/mL in the ascending colon and 2.2 log CFU/mL in the descending ...

6. nature.com nature.com/articles/s41575-020-0344-2

The International Scientific Association for Probiotics and ... Effects of synbiotic supplement on human gut microbiota, body composition and ... Probiotic and synbiotic safety in infants under two years of age ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1051227622001522

The Impact of Synbiotic Treatment on the Levels of Gut ... Gastrointestinal Symptoms and Safety Data. All the 34 patients recruited for the study complained of at least 1 gastrointestinal symptom during the initial ...

8. academic.oup.com academic.oup.com/nutritionreviews/article/83/2/e4/7606372

effect of oral synbiotics on the gut microbiota and inflammatory ... This review demonstrates that synbiotics modulate the gut microbiota by increasing Lactobacillus and propionate across various healthy adult populations.