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

March 9, 2016 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

The Effects of Probiotic Supplementation on Anthropocentric, Nutrients Status, Inflammation, GI Hormones, Quality of Life, and Microflora in Patients Undergoing Gastric Bypass Surgery

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weigh of the participants will be measured in Kg.
Time Frame: 3 months after surgery
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
serum level of vitamin B12 (mg/dl)
Time Frame: 3 months after surgery
3 months after surgery
serum level of vitamin B12 (mg/dl)
Time Frame: 12 months after surgery
12 months after surgery
serum level of vitamin D(ng/ml)
Time Frame: 3 months after surgery
3 months after surgery
serum level of vitamin D (ng/ml)
Time Frame: 12 months after surgery
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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