Symbiotic Use in Post-Bariatric Surgery Patients

February 1, 2024 updated by: University of North Florida

Do Symbiotics Provide Helpful Benefits in Gastrointestinal Related Issues in Weight Loss Surgery Patients?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The topic of interest is the gut microbiome and the impact of symbiotics (prebiotics coupled with probiotics) on gut health after weight loss surgeries due to surgical alterations of the stomach and bowels as a result of the procedures. Symbiotics provide positive gut health benefits, ie. improvement in bowel function and reduction in gastrointestinal distress symptoms such as bloating. However, when conducting a literature review on probiotics/prebiotics, most of the research studies have poor quality and do not cite the quantity of each strain being studied. To date, no research has been conducted on symbiotic administration in post bariatric surgery patients and their relationship regarding improvements in gastrointestinal symptoms.

There is no standard dose recommended for probiotics. Each strain should be given at a dose that has shown to be effective at providing a health benefit to the host through clinical trials. However, no clear criteria has been established to determine what classifies as effective and what health benefits are considered clinically relevant. Most healthcare organizations recommend between 1 to 20 x 109 colony forming units (CFU)/ day for adults. In many cases, higher dosages have been shown to be more effective, but a clear dose-dependent response has not been identified and a "more is better" philosophy does not apply to all strains. Therefore, one rule states that "If a product contains multiple strains, then each strain should be present at levels of 109 to ensure effectiveness."

The primary objective of this study would be to determine the efficacy of symbiotic administration for improving gastrointestinal health in weight loss surgery patients. This study would test the efficacy of a once daily, multi strain symbiotic on gut health changes in weight loss surgery patients, twelve months or greater post-surgery, by testing stool samples prior to administration and then three months after 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 symptoms prior and post symbiotic administration.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • University of North Florida
        • Contact:
        • Contact:
          • Nicole Sayers
          • Phone Number: 904-620-2498
          • Email: irb@unf.edu
        • Principal Investigator:
          • Andrea Y Arikawa, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symbiotic Group
An over-the counter, once daily symbiotic capsule including: 15 billion CFU probiotic blend and 250mg of prebiotic.
Dietary supplement: 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.
Other Names:
  • Celebrate Balance Probiotic Plus Prebiotic
Placebo Comparator: Fiber Group
Once daily capsule of microcrystalline cellulose.
Dietary supplement: Placebo
Daily fiber capsule containing microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symbiotic Changes in Stool Samples
Time Frame: 90 days
The primary objective will 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 after administration of a symbiotic or placebo. Chi-square tests will be performed to show associations between symbiotic intake and stool bacteria diversity and concentrations.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bristol Stool Scale Weekly Changes
Time Frame: 12 weeks
Participants will complete a weekly Bristol Stool Scale that identifies their overall stool consistency for the week.Participants will complete this tool weekly and SPSS software will be used to conduct an independent t-test of mean changes to evaluate the difference in stool form. Total scores can range from 7 through 49, with scores closest to 24.5 representing normal stool form. The comparisons of these tests will be able to provide statistical relevance on the usage of symbiotic supplementation in normal stool form.
12 weeks
Frequency of Weekly Stools
Time Frame: 12 weeks
Participants will complete a weekly survey that identifies the amount of stools produced the week prior. Independent t-test will be performed to show changes in stool frequency.
12 weeks
Gastrointestinal Related Symptoms
Time Frame: 12 weeks
A final Chi-square test of association will be performed using SPSS software to test whether there is a relationship between symbiotic intake and reduction in GI related symptoms. P-values of 0.05 or lower will be used to prove statistical significance for all tests performed.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Florida

Collaborators

Celebrate Nutritional Supplements

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Estimated)

February 9, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2089663-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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