Symbiotic Use in Post-Bariatric Surgery Patients

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252558
• Other study ID #: 2089663-1
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of North Florida
• Contact: Samantha Stavola-Giaconia, MHA
• Phone: 215-806-2792
• Email: sam[@]celebratevitamins.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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when conducting a literature review on probiotics/prebiotics, most of the research studies have poor quality and do not cite the quantity of each strain being studied.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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.
• Placebo
Daily fiber capsule containing microcrystalline cellulose

Locations

Country	Name	City	State
United States	University of North Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of North Florida	Celebrate Nutritional Supplements

Country where clinical trial is conducted

United States, 

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symbiotic Changes in Stool Samples	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	Bristol Stool Scale Weekly Changes	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
Secondary	Frequency of Weekly Stools	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
Secondary	Gastrointestinal Related Symptoms	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