Gastric Bypass Surgery
Conditions
Brief summary
In this study, patients undergoing the bariatric surgery will be assigned to take either probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery. Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will be compared in two groups.
Interventions
DIETARY_SUPPLEMENTprobiotic
OTHERPlacebo
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* BMI\> 40 or \>35 plus other morbidities * Undergoing the gastric bypass surgery * Willing to participate in the study
Exclusion criteria
* History of any chronic GI or kidney disorders, malignancies, or immune deficiencies * Taking any immunomodulatory or immunosuppressor medications * Taking Antibiotics from 4 weeks before and during the intervention * Being on special diet such as vegetarian diet * Doing as a professional Athlete * Pregnancy and Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weigh of the participants will be measured in Kg. | 3 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| serum level of vitamin B12 (mg/dl) | 3 months after surgery |
| serum level of vitamin D(ng/ml) | 3 months after surgery |
| serum level of vitamin D (ng/ml) | 12 months after surgery |
Countries
Iran
Outcome results
None listed