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

National Nutrition and Food Technology Institute50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Gastric Bypass Surgery

Interventions

probioticDIETARY_SUPPLEMENT

PlaceboOTHER

Eligibility

Sex: ALLMin age: 14 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

NNFTRI clinic

Tehran, Tehran Province, Iran

RECRUITING

Outcomes

Primary Outcomes

weigh of the participants will be measured in Kg.

Time frame: 3 months after surgery

Secondary Outcomes

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

Data from ClinicalTrials.gov

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