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Evaluation of the effect of administering probiotic tablets after ROUX-en-Y obesity surgery on gastrointestinal function and metabolic factors and weight changes

Protocol summary

Study aim
Evaluate the effect of administering probiotic tablets for 3 months on gastrointestinal function of patients undergoing ROUX-en-Y surgery during 6 months after surgery.
Design
A double-blinded randomized clinical trial with a parallel group design of 134 patients, enrolled between July 2020 and August 2020, and followed for 6 months.
Settings and conduct
Eligible patients were selected from patients who refer to the clinic of Al-Zahra Hospital. Software:Random Allocation Software 2.0; Numbering sequential from1 to 134 by analyzer. Block randomization consisting 4 patients in each block. Patients categorized to group A,B. Patient get one pocket that been one number and name of group inside.Patients underwent surgical interventions and started receiving medication one week after surgery, with visits at 1wk, 5wk, 9wks and 12wks and 6months after surgery.Biochemical laboratory data such as FBS, HbA1C,TG,mg, Alb,LFT,Vit B12...was measured. Investigation of GI function by Gastrointestinal Quality of Life index questionnaire.
Participants/Inclusion and exclusion criteria
The inclusion criteria were (BMI) ≥ 45 or 35 ≤BMI ≤40 associated with comorbidity. Patients with the following criteria did not enter the study: having evidence of chronic gastrointestinal, hepatic or renal disorders, pregnancy, and breastfeeding. The exclusion criteria were receiving antibiotics, probiotics or probiotic enriched foods, NSAID or insulin within 4 weeks before the study initiation and history of gastrointestinal surgeries.
Intervention groups
Patients receiving medication 1 week after surgery.Patients were given 40 mg pantoprazole mineral supplements according to the protocol of the multivitamin treatment center. After 4 months of surgery, vitamin B12 were prescribed every month. Other necessary supplements were also prescribed.
Main outcome variables
Investigation of GI function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220702055340N1
Registration date: 2022-11-21, 1401/08/30
Registration timing: retrospective

Last update: 2022-11-21, 1401/08/30
Update count: 0
Registration date
2022-11-21, 1401/08/30
Registrant information
Name
Alime Hossein Abdolahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3673 0869
Email address
a.abdolahi155@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of administering probiotic tablets after ROUX-en-Y obesity surgery on gastrointestinal function and metabolic factors and weight changes
Public title
Probiotic in ROUX_en_Y obesity surgery on gastrointestinal function and metabolic factors and weight changes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
BMI ≥ 45 kg/m2 35 ≤BMI ≤40 kg/m2 associated with comorbidity
Exclusion criteria:
having evidence of chronic gastrointestinal, hepatic or renal disorders having evidence of chronic hepatic disorders having evidence of chronic renal disorders Pregnancy Breastfeeding in women Recieving antibiotics, probiotics or probiotic enriched foods, non-steroid anti-inflammatory drugs (NSAID) or insulin within 4 weeks before the study initiation. History of gastrointestinal surgeries
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 134
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients were selected from patients who refer to the clinic of Al-Zahra Hospital. Software:Random Allocation Software 2.0; Numbering sequential from1 to 134 by analyzer. Block randomization consisting 4 patients in each block. Patients categorized to group A,B. Patient get one pocket that been one number and name of group inside. Just pharmacist know about group A and B. pharmacist take them the tablets and then analyzer entered the data
Blinding (investigator's opinion)
Double blinded
Blinding description
The probiotic and placebo were determined by the bio-fermentation pharmaceutical company and the samples in each group were delivered to the researcher after the coding under the names of A and B. the groups were decoded after statistical analysis. In this study, the patients, data collectors and data analysts were unaware of the received interventions.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No.49, 7th Ave., Sepahan Town.,Hezarjarib Blvd.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174614141
Approval date
2020-12-19, 1399/09/29
Ethics committee reference number
IR.MUI.MED.REC.1399.849

Health conditions studied

1

Description of health condition studied
Morbid obesity
ICD-10 code
E66.01
ICD-10 code description
Morbid (severe) obesity due to excess calories

2

Description of health condition studied
Bariatric surgery
ICD-10 code
Z98.84
ICD-10 code description
Bariatric surgery status

Primary outcomes

1

Description
Gastrointestinal Function
Timepoint
start receiving medication 1 week after surgery and start investigation, 5week after surgery, 9weeks after surgery, 12 week after surgery then 6 month after surgery
Method of measurement
Using of Gastrointestinal Quality of Life index questionnaire.

2

Description
Blood sugar
Timepoint
Before surgery and after surgery for up to 6 months
Method of measurement
Blood test

3

Description
Liver enzyme
Timepoint
Before surgery and after surgery for up to 6 months
Method of measurement
Blood test

4

Description
Triglyceride
Timepoint
Before surgery and after surgery for up to 6 months
Method of measurement
Blood test

5

Description
HbA1C
Timepoint
Before surgery and after surgery for up to 6 months
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first group received the probiotic tablets (Familact Co.) daily and started receiving medication one week after surgery until 6 months after surgery.After 4 months of surgery, vitamin B12 were prescribed every month. Other necessary supplements were also prescribed
Category
Treatment - Drugs

2

Description
Control group: Patients underwent bariatric surgery and start receiving placebo one week after surgery and start investigation. Placebo was produced by Zist_Takhmir CO that produce the Femilact. Placebo was produced with the same shape without effective material.After 4 months of surgery, vitamin B12 were prescribed every month. Other necessary supplements were also prescribed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Hamid melali
Street address
Alzahra hospital, Hezarjarib Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
abdolahi88@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Hamid Melali
Street address
General Surgery Department,Alzahra hospital, Sofe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Melali
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
General Surgery Department, Alzahra hospital, Sofe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Hamidmelali@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alime Hossein Abdolahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 49, 7th Ave,. Sepahan Town. Hezarjarib Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174614141
Phone
+98 31 3673 0869
Email
a.abdolahi155@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alime Hossein Abdolahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No.49, 7th Ave., Sepahan Town, Hezarjarib Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174614141
Phone
+98 31 3673 0869
Email
a.abdolahi155@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Outcome of this study Patients information
When the data will become available and for how long
At the end of the study.
To whom data/document is available
Journals, Medical Schools
Under which criteria data/document could be used
To use for other patients or use for other study
From where data/document is obtainable
Alime Hossein Abdolahi a.abdolahi155@gmail.com Dr.Hamid melali Hamidmelali@yahoo.com
What processes are involved for a request to access data/document
They have to explain about their study and how to use our data. They request the formal letter by email, data will send during one week.
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