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Evaluation of the effectiveness of adding probiotic / prebiotic combination to the usual treatment on the severity of depressive symptoms and irritable bowel syndrome

Protocol summary

Study aim
Determining and comparing the effectiveness of probiotic/prebiotic combination on the severity of depressive symptoms and irritable bowel syndrome
Design
The randomized, double-blind clinical trial, with the parallel groups, Phase 3 on 48 patients
Settings and conduct
In this randomized double-blind clinical trial study, 48 eligible patients referred to the gastroenterology and psychiatry clinic of Al-Zahra hospital of Isfahan will be included in the study and will be randomly divided into 2 groups. Patients in the control group will be given the usual treatment, and in the intervention group, a probiotic/prebiotic combination will be prescribed. The patient and the researcher will have no knowledge of the type of intervention and the conditions were double-blind. Then the symptoms of depression and IBS of patients will be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included age 18 to 65 years, diagnosis of moderate to severe IBS, minimum literacy, no depressive disorders, bipolar disorder or psychotic disorders, no suicide plan or serious thoughts at the time of enrollment, no pregnancy or breastfeeding, no history of any bowel surgery, no drug use From the onset of symptoms and consent to participate in the study. Exclusion criteria include the diagnosis of any organic disease during the study, non-cooperation in the use of drugs regularly, and the occurrence of any side effects, including allergic and gastrointestinal complications.
Intervention groups
Intervention group: For patients in this group, in addition to the usual treatment, the probiotic/prebiotic combination is given as one capsule daily for 12 weeks. Control group: For patients in this group, only the usual treatment is used.
Main outcome variables
Depression, Anxiety, Stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190404043159N5
Registration date: 2021-12-13, 1400/09/22
Registration timing: prospective

Last update: 2021-12-13, 1400/09/22
Update count: 0
Registration date
2021-12-13, 1400/09/22
Registrant information
Name
Mohammad Reza Sharbafchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
sharbafchi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of adding probiotic / prebiotic combination to the usual treatment on the severity of depressive symptoms and irritable bowel syndrome
Public title
Evaluation of the effectiveness of probiotic/prebiotic on the severity of depressive symptoms and irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years Diagnosis of moderate to severe IBS based on ROME III criteria Have a minimum literacy Absence of Depressive Disorders, Bipolar Disorders or Psychotic Disorders Based on DSM-V Diagnostic Criteria by Psychiatrist and Psychiatric Assistant No suicidal plans or thoughts at the time of enrollment Do not take antidepressants and anti-anxiety drugs at the time of enrollment until 2 weeks before No pregnancy or breastfeeding No history of any bowel surgery Do not use drugs since the onset of symptoms Satisfaction to participate in the study
Exclusion criteria:
Diagnosis of any organic disease during the study Lack of cooperation in taking medications regularly Causes any side effects, including allergic and gastrointestinal side effects
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 48 eligible patients are randomly selected. For this, the letter A is written on 24 sheets, and the letter B is written on 24 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to observe blindness, the drugs are prepared in the same shape and amount before the intervention and are coded and given to the physician. They prescribe them without knowing the type of each drug. Therefore, the patient, the patient, the person recording the clinical and baseline information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2021-09-27, 1400/07/05
Ethics committee reference number
IR.MUI.MED.REC.1400.510

Health conditions studied

1

Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

Primary outcomes

1

Description
Symptoms of Irritable Bowel Syndrome
Timepoint
Before intervention, 6 and 12 weeks after intervention
Method of measurement
Questionnaire the irritable bowel severity scoring system (IBSSS)

Secondary outcomes

1

Description
Depression
Timepoint
Before intervention, 6 and 12 weeks after intervention
Method of measurement
Questionnaire of Depression, Anxiety and Stress Scale (DASS)

2

Description
Anxiety
Timepoint
Before intervention, 6 and 12 weeks after intervention
Method of measurement
Questionnaire of Depression, Anxiety and Stress Scale (DASS)

3

Description
Stress
Timepoint
Before intervention, 6 and 12 weeks after intervention
Method of measurement
Questionnaire of Depression, Anxiety and Stress Scale (DASS)

Intervention groups

1

Description
Intervention group 1: For patients in this group, in addition to the usual treatment, the probiotic/prebiotic combination of familact 2 Plus (which contains eight bacterial strains and the prebiotic fructooligosaccharide) is given as one capsule daily for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: For patients in this group, only the usual treatment is used and capsules containing corn starch (as a placebo) similar to the intervention group will be prescribed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospial
Full name of responsible person
Mohammad Reza Sharbafchi
Street address
Department of Psychiatry, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sharbafchi@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Fax
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
sharbafchi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
sharbafchi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faranak Zaki-Zadeh
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
sharbafchi@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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