Bariatric Surgery CandidateNCT06252558
Symbiotic Use in Post-Bariatric Surgery Patients
A study testing Symbiotic in people with Bariatric Surgery Candidate, run by University of North Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Symbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 12 months or greater post malabsorptive weight loss procedure
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of North Florida
Jacksonville, Florida, 32224
Andrea Y Arikawa, PhD, 904-620-1433, a.arikawa@unf.edu
Nicole Sayers, 904-620-2498, irb@unf.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Symbiotic, Placebo
- Keywords
- bariatric surgery, symbiotic, prebiotics, probiotics, weight loss surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbioticDietary supplement
Also called Celebrate Balance Probiotic Plus Prebiotic
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.
PlaceboDietary supplement
Daily fiber capsule containing microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Symbiotic Group | Experimental | An over-the counter, once daily symbiotic capsule including: 15 billion CFU probiotic blend and 250mg of prebiotic. Receives: Dietary Supplement: Symbiotic |
| Fiber Group | Placebo comparator | Once daily capsule of microcrystalline cellulose. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (3)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start8 Jan 2024
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Celebrate Nutritional Supplements
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252558
- Sponsor's protocol ID
- 2089663-1
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lim Y, Boster J. Obesity and Comorbid Conditions. StatPearls. Published online October 25, 2021. Accessed March 28, 2022. https://www.ncbi.nlm.nih.gov/books/NBK574535/
Obesity Medicine Association. AMA Classifies Obesity as a Disease | Obesity Medicine AssociationMain. Published June 19, 2013. Accessed May 2, 2022.
Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.
PubMed 32487284Ward ZJ, Bleich SN, Cradock AL, Barrett JL, Giles CM, Flax C, Long MW, Gortmaker SL. Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity. N Engl J Med. 2019 Dec 19;381(25):2440-2450. doi: 10.1056/NEJMsa1909301.
PubMed 31851800Bhutani S, vanDellen MR, Cooper JA. Longitudinal Weight Gain and Related Risk Behaviors during the COVID-19 Pandemic in Adults in the US. Nutrients. 2021 Feb 19;13(2):671. doi: 10.3390/nu13020671.
PubMed 33669622Kim J, Eisenberg D, Azagury D, Rogers A, Campos GM. American Society for Metabolic and Bariatric Surgery position statement on long-term survival benefit after metabolic and bariatric surgery. Surg Obes Relat Dis. 2016 Mar-Apr;12(3):453-459. doi: 10.1016/j.soard.2015.11.021. Epub 2015 Nov 27.
PubMed 26944548American Society of Metabolic and Bariatric Surgery. Access to Care Fact Sheet. Published 2011. Accessed March 29, 2022. https://asmbs.org/resources/access-to-care-fact-sheet
Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, De Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery. Surg Obes Relat Dis. 2022 Dec;18(12):1345-1356. doi: 10.1016/j.soard.2022.08.013. Epub 2022 Oct 21.
PubMed 36280539Carter J, Chang J, Birriel TJ, Moustarah F, Sogg S, Goodpaster K, Benson-Davies S, Chapmon K, Eisenberg D. ASMBS position statement on preoperative patient optimization before metabolic and bariatric surgery. Surg Obes Relat Dis. 2021 Dec;17(12):1956-1976. doi: 10.1016/j.soard.2021.08.024. Epub 2021 Sep 3. No abstract available.
PubMed 34629296Youdim A. Bariatric Surgery. Merck Manual Professional Version. Published August 2021. Accessed April 17, 2022. https://www.merckmanuals.com/professional/nutritional-disorders/obesity-and-the-metabolic-syndrome/bariatric-surgery
Stefater MA, Wilson-Perez HE, Chambers AP, Sandoval DA, Seeley RJ. All bariatric surgeries are not created equal: insights from mechanistic comparisons. Endocr Rev. 2012 Aug;33(4):595-622. doi: 10.1210/er.2011-1044. Epub 2012 May 1.
PubMed 22550271Center for Disease Control and Prevention. Adult Obesity Facts. Published September 30, 2021. Accessed March 28, 2022. https://www.cdc.gov/obesity/data/adult.html
Owens DK. Interpretation of cost-effectiveness analyses. J Gen Intern Med. 1998 Oct;13(10):716-7. doi: 10.1046/j.1525-1497.1998.00211.x. No abstract available.
PubMed 9798822Weight Management Dietetic Practice Group. Pocket Guide to Bariatric Surgery. Third Edition. (Isom KA, Majumdar MC, eds.).; 2022.
International Federation of Surgery for Obesity. Gastric Bypass Surgery. Accessed April 12, 2022. https://www.ifso.com/roux-en-y-gastric-bypass/
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Symbiotics Provide Helpful Benefits in Gastrointestinal Related Issues in Weight Loss Surgery Patients?
- ClinicalTrials.gov ID
- NCT06252558
- Acronym / sponsor ID
- 2089663-1
- Conditions
- Bariatric Surgery Candidate
- Keywords
- bariatric surgery, symbiotic, prebiotics, probiotics, weight loss surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of North FloridaUniversity, hospital or other
- Collaborators
- Celebrate Nutritional Supplements
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbiotic Group | Experimental | Dietary Supplement: SymbioticAn over-the counter, once daily symbiotic capsule including: 15 billion CFU probiotic blend and 250mg of prebiotic. |
| Fiber Group | Placebo comparator | Dietary Supplement: PlaceboOnce daily capsule of microcrystalline cellulose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 12 months or greater post malabsorptive weight loss procedure
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SymbioticAlso: Celebrate Balance Probiotic Plus PrebioticOne-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. | Dietary supplement | Symbiotic Group |
| PlaceboDaily fiber capsule containing microcrystalline cellulose | Dietary supplement | Fiber Group |
Primary outcome
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.
3 secondary outcomes
Bristol Stool Scale Weekly Changes
Time frame: 12 weeks
Frequency of Weekly Stools
Time frame: 12 weeks
Gastrointestinal Related Symptoms
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- BackgroundLim Y, Boster J. Obesity and Comorbid Conditions. StatPearls. Published online October 25, 2021. Accessed March 28, 2022. https://www.ncbi.nlm.nih.gov/books/NBK574535/
- BackgroundObesity Medicine Association. AMA Classifies Obesity as a Disease | Obesity Medicine AssociationMain. Published June 19, 2013. Accessed May 2, 2022.
- Background: PubMed 32487284Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.
- Background: PubMed 31851800Ward ZJ, Bleich SN, Cradock AL, Barrett JL, Giles CM, Flax C, Long MW, Gortmaker SL. Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity. N Engl J Med. 2019 Dec 19;381(25):2440-2450. doi: 10.1056/NEJMsa1909301.
- Background: PubMed 33669622Bhutani S, vanDellen MR, Cooper JA. Longitudinal Weight Gain and Related Risk Behaviors during the COVID-19 Pandemic in Adults in the US. Nutrients. 2021 Feb 19;13(2):671. doi: 10.3390/nu13020671.
- Background: PubMed 26944548Kim J, Eisenberg D, Azagury D, Rogers A, Campos GM. American Society for Metabolic and Bariatric Surgery position statement on long-term survival benefit after metabolic and bariatric surgery. Surg Obes Relat Dis. 2016 Mar-Apr;12(3):453-459. doi: 10.1016/j.soard.2015.11.021. Epub 2015 Nov 27.
- BackgroundAmerican Society of Metabolic and Bariatric Surgery. Access to Care Fact Sheet. Published 2011. Accessed March 29, 2022. https://asmbs.org/resources/access-to-care-fact-sheet
- Background: PubMed 36280539Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, De Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery. Surg Obes Relat Dis. 2022 Dec;18(12):1345-1356. doi: 10.1016/j.soard.2022.08.013. Epub 2022 Oct 21.
- Background: PubMed 34629296Carter J, Chang J, Birriel TJ, Moustarah F, Sogg S, Goodpaster K, Benson-Davies S, Chapmon K, Eisenberg D. ASMBS position statement on preoperative patient optimization before metabolic and bariatric surgery. Surg Obes Relat Dis. 2021 Dec;17(12):1956-1976. doi: 10.1016/j.soard.2021.08.024. Epub 2021 Sep 3. No abstract available.
- BackgroundYoudim A. Bariatric Surgery. Merck Manual Professional Version. Published August 2021. Accessed April 17, 2022. https://www.merckmanuals.com/professional/nutritional-disorders/obesity-and-the-metabolic-syndrome/bariatric-surgery
- Background: PubMed 22550271Stefater MA, Wilson-Perez HE, Chambers AP, Sandoval DA, Seeley RJ. All bariatric surgeries are not created equal: insights from mechanistic comparisons. Endocr Rev. 2012 Aug;33(4):595-622. doi: 10.1210/er.2011-1044. Epub 2012 May 1.
- BackgroundCenter for Disease Control and Prevention. Adult Obesity Facts. Published September 30, 2021. Accessed March 28, 2022. https://www.cdc.gov/obesity/data/adult.html
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symbiotic in people with Bariatric Surgery Candidate, run by University of North Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha Stavola-Giaconia, MHA (215-806-2792, sam@celebratevitamins.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symbiotic Changes in Stool Samples (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06252558, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.