Effect of Prebiotic and Synbiotic Supplementation in Individuals Undergoing Roux-en-y Gastric Bypass.
1 other identifier
interventional
18
1 country
1
Brief Summary
The study will recruit patients submitted to bariatric surgery. Individuals will be supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days. Immunological, metabolic and anthropometric parameters will be assessed before and after the supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate plasma concentrations of immunological and metabolic parameters and anthropometric measures of subjects undergoing gastric bypass Roux-Y.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 2, 2014
CompletedFirst Posted
Study publicly available on registry
June 9, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedApril 14, 2017
April 1, 2017
7 months
June 2, 2014
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in IL-1 beta concentrations
Will be evaluated IL-1 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in IL-6 concentrations
Will be evaluated IL-6 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in TNF-alpha concentrations
Will be evaluated TNF-alpha plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary Outcomes (10)
Change in nutritional status
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in risk of inflammatory and nutritional complications
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation)
Change in fasting glucose concentrations
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in fasting insulin concentrations
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in HOMA-IR index
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
- +5 more secondary outcomes
Study Arms (3)
Prebiotic
EXPERIMENTAL6 g/day of prebiotic (fructooligosaccharides) for 15 days.
Synbiotic
EXPERIMENTAL6 g/day of synbiotic (fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019) for 15 days.
Placebo
PLACEBO COMPARATOR6 g/day of placebo (maltodextrin) for 15 days.
Interventions
Eligibility Criteria
You may qualify if:
- Age greater than 18 years and less than 65 years
- Body mass index (BMI)\> 40kg/m2 or\> 35kg/m2 with at least one comorbidity
- Failure in the non-pharmacological and pharmacological treatment.
You may not qualify if:
- Significant intellectual limitations without adequate family support.
- Uncontrolled psychiatric disorder.
- Alcohol dependence and / or illicit drugs dependence.
- Current use of anti-inflammatory drugs and / or antibiotics and / or immunosuppressants
- Display intolerance prebiotics and / or probiotics and / or symbiotic
- Having made use of prebiotic and / or probiotic and / or symbiotic prior to the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitário Polydoro Ernani de São Thiago
Florianópolis, Santa Catarina, 88040-900, Brazil
Related Publications (1)
Fernandes R, Beserra BT, Mocellin MC, Kuntz MG, da Rosa JS, de Miranda RC, Schreiber CS, Frode TS, Nunes EA, Trindade EB. Effects of Prebiotic and Synbiotic Supplementation on Inflammatory Markers and Anthropometric Indices After Roux-en-Y Gastric Bypass: A Randomized, Triple-blind, Placebo-controlled Pilot Study. J Clin Gastroenterol. 2016 Mar;50(3):208-17. doi: 10.1097/MCG.0000000000000328.
PMID: 25909598RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo Fernandes, Master's
Universidade Federal de Santa Catarina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor in Tropical Diseases
Study Record Dates
First Submitted
June 2, 2014
First Posted
June 9, 2014
Study Start
October 1, 2013
Primary Completion
May 1, 2014
Study Completion
July 1, 2015
Last Updated
April 14, 2017
Record last verified: 2017-04