Investigating the effect of probiotic consumption on the rate of constipation after bariatric surgery patients compared with placebo
Design
َA control group, with parallel groups, double-blind, randomized, on 27 patients.
Patients will be randomized in blocks of four individually using randomization.com site using block randomization method.
Allocation concealment will be done by using opaque, sealed, and consecutively numbered envelopes.
Settings and conduct
All patients in the surgery department of Imam Reza Hospital in Mashhad have undergone obesity or bariatric surgery and are divided into two control and intervention groups.
Therapeutic intervention is administered in the form of Prodigest 500 mg probiotic capsules (containing Lactobacillus and Bifidobacterium probiotics) daily for 2 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with BMI greater than 40 with or without obesity-related comorbidities
Patient with BMI 35-40 with medical comorbidity
A patient who has failed a weight loss diet under the supervision of a doctor.
The patient is psychiatrically stable
Confirmation of patients' constipation based on Rome's criteria after one month of surgery
Exit criteria:
A disease that makes anesthesia or surgery dangerous for the patient
The patient is mentally incompetent to understand the operation technique
Inability or unwillingness to change lifestyle after surgery
Abuse of certain drugs and alcohol or any other addiction
Active bulimia nervosa or other eating disorders
The patient is psychiatrically unstable
Unsupportive family
Non-confirmation of patients' constipation based on Rome's criteria after one month of surgery
Intervention groups
Bariatric surgery patients receiving probiotics
Bariatric surgery patients receiving placebo
Main outcome variables
Investigation of constipation and defecation within two months after consuming probiotic digest
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190423043356N4
Registration date:2023-08-07, 1402/05/16
Registration timing:registered_while_recruiting
Last update:2023-08-07, 1402/05/16
Update count:0
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Amin Dalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 2557
Email address
daliliam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotics in postoperative constipation in bariatric surgery patients
Public title
The effect of probiotics in postoperative constipation in bariatric surgery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with BMI greater than 40 with or without obesity-related comorbidities
Patient with BMI 35-40 with medical comorbidity
A patient who has failed a weight loss diet under the supervision of a doctor
The patient is psychiatrically stable
Confirmation of patients' constipation based on Rome's criteria after one month of surgery
Exclusion criteria:
A disease that makes anesthesia or surgery dangerous for the patient
The patient is mentally incompetent to understand the operation technique
Inability or unwillingness to change lifestyle after surgery
Abuse of drugs and alcohol or any other addiction
Active bulimia nervosa or other eating disorders
The patient is psychiatrically unstable
Unsupportive family
Non-confirmation of patients' constipation based on Rome's criteria after one month of surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
27
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be individually randomized using the block randomization method in quadruple blocks by randomization.com website, Allocation concealment will be done using sealed, opaque, and sequentially numbered envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, The nurse who collects the data, Data analyzer
Placebo
Used
Assignment
Parallel
Other design features
It is a diagnostic and therapeutic method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Imam Reza Hospital, Ibn-e-Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.MUMS.IRH.REC.1402.035
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
Primary outcomes
1
Description
The severity of constipation
Timepoint
Visit at the end of the first, second, fourth, sixth and eighth week
Method of measurement
Physical examination by the surgeon and according to Rome IV Criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bariatric surgery patients receiving probiotics
Category
Treatment - Drugs
2
Description
Control group: Bariatric surgery patients receiving placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amin Dalili
Street address
Imam Reza Hospital, Ibn-e-Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3851 5255
Email
daliliam@mumus.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreshi Building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mashhad University of Medical Sciences
Position
Asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Fellowship of minimally invasive and bariatric surgery
Street address
Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 2557
Email
Daliliam@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Fellowship of minimally invasive and bariatric surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 2557
Email
Daliliam@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Fellowship of minimally invasive and bariatric surgery
Street address
Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 2557
Email
Daliliam@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available