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Status unknownNCT02708589Updated Mar 15, 2016

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

A Phase 2/3 interventional study of probiotic and Placebo in Gastric Bypass Surgery, sponsored by National Nutrition and Food Technology Institute. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-15.

Sponsored by National Nutrition and Food Technology Institute · Phase 2/3, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
14 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Bypass Surgery
03

In context

Lead sponsor

National Nutrition and Food Technology Institute is the lead sponsor of 62 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • BMI> 40 or >35 plus other morbidities
  • Undergoing the gastric bypass surgery
  • Willing to participate in the study

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • Dietary supplementprobiotic
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. weigh of the participants will be measured in Kg.

    Time frame: 3 months after surgery

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • NNFTRI clinic
    Tehran, 19435, Iran, Islamic Republic of
    Recruiting
08

References and documents

Publications

  • Mokhtari Z, Karbaschian Z, Pazouki A, Kabir A, Hedayati M, Mirmiran P, Hekmatdoost A. The Effects of Probiotic Supplements on Blood Markers of Endotoxin and Lipid Peroxidation in Patients Undergoing Gastric Bypass Surgery; a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial with 13 Months Follow-Up. Obes Surg. 2019 Apr;29(4):1248-1258. doi: 10.1007/s11695-018-03667-6. PubMed 30612325 ↗
  • Karbaschian Z, Mokhtari Z, Pazouki A, Kabir A, Hedayati M, Moghadam SS, Mirmiran P, Hekmatdoost A. Probiotic Supplementation in Morbid Obese Patients Undergoing One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) Surgery: a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial. Obes Surg. 2018 Sep;28(9):2874-2885. doi: 10.1007/s11695-018-3280-2. PubMed 29725975 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02708589
Lead sponsor
National Nutrition and Food Technology Institute
Responsible party
Dr Azita Hekmatdoost (Associate Prof, National Nutrition and Food Technology Institute) — Principal investigator
First posted
Mar 15, 2016
Start date
Sep 2015
Primary completion
Sep 2017 (estimated)
Last update
Mar 15, 2016
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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