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

Trial Summary

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 data supports the effectiveness of the treatment Synbiotic+ for gastrointestinal disorders?

Research shows that synbiotics, which combine probiotics and prebiotics, can improve bowel habits and enhance the quality of life related to gastrointestinal function. Studies have found that synbiotics help maintain healthy gut bacteria and reduce symptoms in people with chronic gastrointestinal issues. ^{1 2 3 4 5}

Is Synbiotic+ safe for use in humans?

Research shows that synbiotics, including Synbiotic+, are generally safe for use in humans, including infants, children, and immune-compromised adults. Most studies found no major safety concerns, and any side effects were usually mild and not directly linked to the synbiotic product. ^{6 7 8 9 10}

How is Synbiotic+ treatment different from other treatments for gastrointestinal disorders?

Synbiotic+ is unique because it combines probiotics (beneficial bacteria) and prebiotics (food for these bacteria) to improve gut health by restoring the balance of gut bacteria, which can lead to better gastrointestinal function and symptom relief compared to standard therapies. ^{2 3 11 12 13}

What is the purpose of this trial?

The aim of this study is to determine how regular consumption of Synbiotic+, a dietary supplement that contains prebiotics, probiotics, and postbiotics, impacts functional gastrointestinal health, markers of intestinal inflammation and immune health, and influences mood and behavior. The primary outcome will be to assess gastrointestinal health using bowel movement tracking, self-report and objective assessments of gastrointestinal symptom severity, stool levels of short chain fatty acids, changes in the gut microbiota, including recovery of LGG and BB-12, and functional measures of the microbiome. Secondary outcomes will include stool and blood markers of gut barrier function and intestinal inflammation, immune health, and self-assessments of stress, anxiety, sleep, and quality of life.

Eligibility Criteria

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

I am under 25 or over 65 years old.

BMI >30

Pregnant and breastfeeding individuals

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

References

1. England 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. [2022]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Efficiency of a new synbiotic drink in treatment of chronic diseases of gastrointestinal tract and concomitant dysbacteriosis]. [2016]

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

Synbiotic therapy reduces the pathological gram-negative rods caused by an increased acetic acid concentration in the gut. [2021]

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

The effects of probiotics, prebiotics and synbiotics on the reduction of IBD complications, a periodic review during 2009-2020. [2021]

5. Greece pubmed.ncbi.nlm.nih.gov

Synbiotics and gastrointestinal function-related quality of life after elective colorectal cancer resection. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The administration of probiotics and synbiotics in immune compromised adults: is it safe? [2014]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Side Effects Associated with Probiotic Use in Adult Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Probiotic and synbiotic safety in infants under two years of age. [2014]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Quantitative Risk-Benefit Analysis of Probiotic Use for Irritable Bowel Syndrome and Inflammatory Bowel Disease. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of probiotics and synbiotics in children under 18 years of age. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Effect of synbiotic in constipated adult women - a randomized, double-blind, placebo-controlled study of clinical response. [2022]

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

Synbiotic approaches to human health and well-being. [2021]

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

Beneficial effects of a synbiotic supplement on self-perceived gastrointestinal well-being and immunoinflammatory status of healthy adults. [2018]