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Probiotic

Symbiotic Group for Bariatric Surgery Candidates

N/A
Recruiting
Research Sponsored by University of North Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial will test the effectiveness of a daily probiotic on the gut health of weight loss surgery patients. Participants will provide stool samples before and after taking the probiotic for three months. They will also

Who is the study for?
This trial is for individuals preparing to undergo bariatric surgery. They should be willing to take a daily supplement or placebo and provide stool samples before and three months after the treatment. Participants must also be open to discussing their bowel habits, stool consistency, and any gastrointestinal symptoms.Check my eligibility
What is being tested?
The study is testing the effects of a multi-strain symbiotic on gut health in post-bariatric surgery patients compared with a placebo. It's a double-blind study, meaning neither the researchers nor participants know who gets the real treatment versus the placebo.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include digestive discomfort or changes in bowel habits due to alterations in gut bacteria from taking symbiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Symbiotic Changes in Stool Samples
Secondary outcome measures
Bristol Stool Scale Weekly Changes
Frequency of Weekly Stools
Gastrointestinal Related Symptoms

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Symbiotic GroupExperimental Treatment1 Intervention
An over-the counter, once daily symbiotic capsule including: 15 billion CFU probiotic blend and 250mg of prebiotic.
Group II: Fiber GroupPlacebo Group1 Intervention
Once daily capsule of microcrystalline cellulose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Symbiotic
2012
Completed Phase 3
~450

Find a Location

Who is running the clinical trial?

University of North FloridaLead Sponsor
5 Previous Clinical Trials
3,872 Total Patients Enrolled
Celebrate Nutritional SupplementsUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process open for this medical study at present?

"As per details available on clinicaltrials.gov, this medical investigation is actively in search of qualified participants. The trial was initially shared on January 8th, 2024 and most recently revised on February 1st, 2024."

Answered by AI
Recent research and studies
JamaJournal
Differences in Obesity Prevalence by Demographic Characteristics and Urbanization Level Among Adults in the United States, 2013-2016
Hales, Craig M., Cheryl D. Fryar, Margaret D. Carroll, David S. Freedman, Yutaka Aoki, and Cynthia L. Ogden. 2018. “Differences in Obesity Prevalence by Demographic Characteristics and Urbanization Level Among Adults in the United States, 2013-2016”. Jama. American Medical Association (AMA). doi:10.1001/jama.2018.7270.
clinicaltrials.govStudy
Symbiotic Use in Post-Bariatric Surgery Patients
2024. "Symbiotic Use in Post-Bariatric Surgery Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06252558.
All > Probiotics
~55 spots leftby Aug 2024
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