Symbiotic Use in Post-Bariatric Surgery Patients

U

University of North Florida

Status

Enrolling

Conditions

Bariatric Surgery Candidate

Treatments

Dietary Supplement: Symbiotic
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06252558
2089663-1

Details and patient eligibility

About

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.

Full 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when conducting a literature review on probiotics/prebiotics, most of the research studies have poor quality and do not cite the quantity of each strain being studied.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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

110 participants in 2 patient groups, including a placebo group

Symbiotic Group
Experimental group
Description:
An over-the counter, once daily symbiotic capsule including: 15 billion CFU probiotic blend and 250mg of prebiotic.
Treatment:
Dietary Supplement: Symbiotic
Fiber Group
Placebo Comparator group
Description:
Once daily capsule of microcrystalline cellulose.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Central trial contact

Andrea Arikawa, PhD; Samantha Stavola-Giaconia, MHA

Data sourced from clinicaltrials.gov

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