Recruiting

Symbiotic Use

Sponsor:

University of North Florida

Code:

NCT06252558

Conditions

Bariatric Surgery Candidate

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Symbiotic

Placebo

Study Details

Brief summary:

The purpose of this double blind, randomized control trial would be to test the efficacy of a once daily, multi strain symbiotic on gut health changes in weight loss surgery patients by testing stool samples prior to administration and then three months post administration of the symbiotic to monitor any changes in bacteria in the stool samples. Study participants will also complete a survey that evaluates their bowel habits, stool consistency, and gastrointestinal related symptoms.

Conditions

Bariatric Surgery Candidate

Study ID

NCT06252558

Start date

Jan 8, 2024

Status verified date

Feb, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Symbiotic Group

An over-the counter, once daily symbiotic capsule including: 15 billion CFU probiotic blend and 250mg of prebiotic.

placebo comparator: Fiber Group

Once daily capsule of microcrystalline cellulose.

Interventions

Symbiotic

One-a-day administration of a capsule supplement containing:15 billion CFU probiotic blend (Lactobacillus acidophilus La-14, Bifidobacterium longum BB536, Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus GG, Lactobacillus gasseri Lg-36) and 250mg of chicory root inulin.

Placebo

Daily fiber capsule containing microcrystalline cellulose

Primary outcome measure

  • Symbiotic Changes in Stool Samples [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Samantha Stavola-Giaconia, MHA

215-806-2792sam@celebratevitamins.com

Andrea Arikawa, PhD

904-620-1433a.arikawa@unf.edu

Locations

University of North Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Andrea Y Arikawa, PhD

904-620-1433a.arikawa@unf.edu

Nicole Sayers

904-620-2498irb@unf.edu

Principal Investigator:

Andrea Y Arikawa, PhD

More Information

Sponsor

University of North Florida

Last update posted

Feb 9, 2024

Last verified

Feb, 2024

Keywords

  • bariatric surgery
  • symbiotic
  • prebiotics
  • probiotics
  • weight loss surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Florida on 2024-02-09.