Symbiotic Use in Post-Bariatric Surgery Patients

NCT06252558 | Recruiting DMC

• 1 other identifier: 2089663-1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

bariatric surgery; symbiotic; prebiotics; probiotics; weight loss surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Bristol Stool Scale Weekly Changes

  12 weeks

• Frequency of Weekly Stools

  12 weeks

• Gastrointestinal Related Symptoms

  12 weeks

Study Arms (2)

Symbiotic Group

EXPERIMENTAL

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

Dietary Supplement: Symbiotic

Fiber Group

PLACEBO COMPARATOR

Once daily capsule of microcrystalline cellulose.

Dietary Supplement: Placebo

Interventions

Symbiotic DIETARY_SUPPLEMENT

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.

Also known as: Celebrate Balance Probiotic Plus Prebiotic

Symbiotic Group

Placebo DIETARY_SUPPLEMENT

Daily fiber capsule containing microcrystalline cellulose

Fiber Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• months or greater post malabsorptive weight loss procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Florida: lead
• Celebrate Nutritional Supplements: collaborator

Study Sites (1)

University of North Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Publications (51)

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MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Central Study Contacts

Samantha Stavola-Giaconia, MHA

CONTACT

215-806-2792; sam@celebratevitamins.com

Andrea Arikawa, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: January 8, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

US (1)