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

National Nutrition and Food Technology Institute

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Gastric Bypass Surgery

Treatments: Other: Placebo; Dietary Supplement: probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT02708589

600

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

probiotic

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: probiotic

Placebo

Placebo Comparator group

Description:

Placebo capsules have identical appearance to probiotic capsules and contain Maltodextrin.

Treatment:

Other: Placebo