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

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ClinicalTrials.gov Identifier: NCT02708589
Recruitment Status : Unknown
Verified March 2016 by Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute.
Recruitment status was:  Recruiting
First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, 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.

Condition or disease Intervention/treatment Phase
Gastric Bypass Surgery Dietary Supplement: probiotic Other: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017

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



Primary Outcome Measures :
  1. weigh of the participants will be measured in Kg. [ Time Frame: 3 months after surgery ]

Secondary Outcome Measures :
  1. serum level of vitamin B12 (mg/dl) [ Time Frame: 3 months after surgery ]
  2. serum level of vitamin B12 (mg/dl) [ Time Frame: 12 months after surgery ]
  3. serum level of vitamin D(ng/ml) [ Time Frame: 3 months after surgery ]
  4. serum level of vitamin D (ng/ml) [ Time Frame: 12 months after surgery ]


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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708589


Locations
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Iran, Islamic Republic of
NNFTRI clinic Recruiting
Tehran, Iran, Islamic Republic of, 19435
Contact: Azita Hekmatdoost, MD, PhD    9123065084    a_hekmat2000@yahoo.com   
Sponsors and Collaborators
National Nutrition and Food Technology Institute