The Effects of Probiotic Supplementation on the Results of Gastric Bypass Surgery

Phase 2

• Conditions: Gastric Bypass Surgery
• Interventions: Other: Placebo; Dietary Supplement: probiotic

• Registration Number: NCT02708589
• Lead Sponsor: National Nutrition and Food Technology Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2016-03
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-09
• Last Update Submitted: 2016-03-09
• Study First Posted: 2016-03-15
• Last Update Posted: 2016-03-15
• Primary Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsules have identical appearance to probiotic capsules and contain Maltodextrin.
probiotic	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).

Primary Outcome Measures

Name	Time	Method
weigh of the participants will be measured in Kg.	3 months after surgery

Secondary Outcome Measures

Name	Time	Method
serum level of vitamin D(ng/ml)	3 months after surgery
serum level of vitamin D (ng/ml)	12 months after surgery
serum level of vitamin B12 (mg/dl)	12 months after surgery

Trial Locations

Locations (1)

NNFTRI clinic; 🇮🇷 Tehran, Iran, Islamic Republic of