Obesity, Bariatric surgery, Gastrointestinal Microbiome, Dysbiosis
Conditions
Interventions
This will be an experimental, prospective, randomized, cross-over and double-blind study with a control group (placedo). In initial contact (T0), patients with and without symptoms (n = 56 in each gro
G07.203.300.456.500
Sponsors
Universidade Federal do Paraná
Universidade Federal do Paraná
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Adult patients (18-60 years old); both sexes; who underwent Roux-en-Y Gastric Bypass 1 year ago and signed the IC; Of these, for the intervention with probiotics, only patients who report at least 1 gastrointestinal symptom of moderate to severe intensity in the GSRS questionnaire will be included.
Exclusion criteria
Exclusion criteria: Patients undergoing other surgical techniques will be excluded; those who underwent reoperation or surgical correction; who used antibiotics during the study period or who did not use the placebo / probiotic for 12 days or more (20%) during each phase of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe a reduction of 1 point in the score of the moderate (s) symptom (s) reported in the GSRS questionnaire in patients treated with probiotics. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe in the patients treated with probiotics the resolution of bacterial overgrowth of the small intestine, by reducing the ppm of expired hydrogen, verified by the spirometry method; alteration of the intestinal microbiota evaluated by the r16S method of genetic sequencing of bacteria from feces; improvement of the profile of the metabolites produced by the intestinal microbiota, evaluated by the blood plasma nuclear magnetic resonance methodology; improvement of the biochemical profile assessed from the blood test performed. | — |
Countries
Brazil
Contacts
Public ContactNathalia Wagner
Outcome results
None listed