Gastric Bypass Surgery Clinical Trial
Official title:
The Effects of Probiotic Supplementation on Anthropocentric, Nutrients Status, Inflammation, GI Hormones, Quality of Life, and Microflora in Patients Undergoing Gastric Bypass Surgery
NCT number | NCT02708589 |
Other study ID # | 600 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2/Phase 3 |
First received | March 1, 2016 |
Last updated | March 9, 2016 |
Start date | September 2015 |
Verified date | March 2016 |
Source | National Nutrition and Food Technology Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: FDA |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | NNFTRI clinic | Tehran |
Lead Sponsor | Collaborator |
---|---|
National Nutrition and Food Technology Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | weigh of the participants will be measured in Kg. | 3 months after surgery | No | |
Secondary | serum level of vitamin B12 (mg/dl) | 3 months after surgery | No | |
Secondary | serum level of vitamin B12 (mg/dl) | 12 months after surgery | No | |
Secondary | serum level of vitamin D(ng/ml) | 3 months after surgery | No | |
Secondary | serum level of vitamin D (ng/ml) | 12 months after surgery | No |
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