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Probiotic

Probiotics for Post-Bariatric Surgery Patients

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
Must not have
LapBand or Intra-gastric balloon patients due to lack of surgical alteration to gut
Individuals who have not had an approved weight loss procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a LapBand or an intra-gastric balloon without gut surgery.
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I have not undergone any approved weight loss surgeries.
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I have trouble swallowing or digesting food.
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I have a digestive issue that makes it hard to provide a stool sample.
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I am currently taking a daily supplement for gut health.
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I am currently on antibiotics prescribed by my doctor.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Symbiotic Changes in Stool Samples
Secondary study objectives
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

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Who is running the clinical trial?

Celebrate Nutritional SupplementsUNKNOWN
University of North FloridaLead Sponsor
6 Previous Clinical Trials
3,882 Total Patients Enrolled
~60 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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