The Effects of Probiotic Supplementation on the Results of Gastric Bypass Surgery
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|ClinicalTrials.gov Identifier: NCT02708589|
Recruitment Status : Unknown
Verified March 2016 by Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute.
Recruitment status was: Recruiting
First Posted : March 15, 2016
Last Update Posted : March 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastric Bypass Surgery||Dietary Supplement: probiotic Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2017|
Active Comparator: probiotic
the probiotics capsules contain 7 strains of friendly bacteria (Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium longum, and Lactobacillus bulgaricus) and prebiotic (fructooligosaccharide).
Dietary Supplement: probiotic
Placebo Comparator: Placebo
Placebo capsules have identical appearance to probiotic capsules and contain Maltodextrin.
- weigh of the participants will be measured in Kg. [ Time Frame: 3 months after surgery ]
- serum level of vitamin B12 (mg/dl) [ Time Frame: 3 months after surgery ]
- serum level of vitamin B12 (mg/dl) [ Time Frame: 12 months after surgery ]
- serum level of vitamin D(ng/ml) [ Time Frame: 3 months after surgery ]
- serum level of vitamin D (ng/ml) [ Time Frame: 12 months after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708589
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of, 19435|
|Contact: Azita Hekmatdoost, MD, PhD 9123065084 firstname.lastname@example.org|