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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02708589
• Other study ID #: 600
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 1, 2016
• Last updated: March 9, 2016
• Start date: September 2015

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Bypass Surgery

Intervention

Dietary Supplement:
• probiotic

Other:
• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	NNFTRI clinic	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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