NCT02708589

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

March 1, 2016

Last Update Submit

March 9, 2016

Conditions

Gastric Bypass Surgery

Outcome Measures

Primary Outcomes (1)

  • weigh of the participants will be measured in Kg.

    3 months after surgery

Secondary Outcomes (4)

  • serum level of vitamin B12 (mg/dl)

    3 months after surgery

  • serum level of vitamin B12 (mg/dl)

    12 months after surgery

  • serum level of vitamin D(ng/ml)

    3 months after surgery

  • serum level of vitamin D (ng/ml)

    12 months after surgery

Study Arms (2)

probiotic

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

probioticDIETARY_SUPPLEMENT
probiotic
PlaceboOTHER
Placebo

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NNFTRI clinic

Tehran, Tehran Province, 19435, Iran

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30612325DERIVED

  • 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.

    PMID: 29725975DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 15, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

IR(1)