Testing a symbiotic supplement for gut health in post-bariatric surgery patients
Do Symbiotics Provide Helpful Benefits in Gastrointestinal Related Issues in Weight Loss Surgery Patients?
NA · University of North Florida · NCT06252558
This study is testing a daily gut health supplement to see if it helps people feel better after weight loss surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Florida (other) |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06252558 on ClinicalTrials.gov |
What this trial studies
This double-blind, randomized control trial aims to evaluate the effectiveness of a daily multi-strain symbiotic supplement on gut health in patients who have undergone weight loss surgery. Participants will provide stool samples before and three months after taking the supplement to assess changes in gut bacteria. Additionally, they will complete surveys regarding their bowel habits and gastrointestinal symptoms. The study addresses the gap in research regarding the impact of symbiotics on gut health following surgical alterations to the digestive system.
Who should consider this trial
Good fit: Ideal candidates are individuals who are at least 12 months post-malabsorptive weight loss surgery.
Not a fit: Patients who have undergone LapBand or intra-gastric balloon procedures may not benefit from this study due to the lack of significant surgical alteration to the gut.
Why it matters
Potential benefit: If successful, this study could improve gut health and reduce gastrointestinal distress in post-bariatric surgery patients.
How similar studies have performed: While there is limited research specifically on symbiotics in post-bariatric surgery patients, similar studies on probiotics and prebiotics have shown potential benefits in gut health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 12 months or greater post malabsorptive weight loss procedure Exclusion Criteria: * LapBand or Intra-gastric balloon patients due to lack of surgical alteration to gut * Individuals who have not had an approved weight loss procedure * Individuals with impaired gastrointestinal function which would impair ingestion of oral supplement * Individuals with impaired gastrointestinal function which would impair ability to collect stool sample * Inability to comprehend and complete assessment tools * Inability to adhere to 90-day capsule supplement administration * Currently taking daily probiotic, prebiotic, or symbiotic supplement * Currently taking antibiotic treatment from physician
Where this trial is running
Jacksonville, Florida
- University of North Florida — Jacksonville, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Samantha Stavola-Giaconia, MHA
- Email: sam@celebratevitamins.com
- Phone: 215-806-2792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bariatric Surgery Candidate, bariatric surgery, symbiotic, prebiotics, probiotics, weight loss surgery