The efficacy of synbiotic supplements containing Bacillus coagulans and inulin with low FODMAP diet compared with low FODMAP diet alone on inflammatory factors, clinical outcomes and quality of life in patients with irritable bowel syndrome
To investigate the efficacy of synbiotic supplements containing Bacillus coagulans and inulin with low FODMAP diet compared with low FODMAP diet alone on inflammatory factors, clinical outcomes and quality of life in patients with irritable bowel syndrome.
Design
Randomized Clinical Trial double blind
Settings and conduct
In this study, patients with irritable bowel syndrome referring to Taleghani Hospital, if they wish to participate in the study informed consent of them will be taken. Patients were randomized to receive a synbiotic containing Bacillus coagulans plus low FODMAP diet or low FODMAP diet (and placebo) for 8 weeks. Before and after the intervention blood and fecal samples will be collected and scores will be evaluated for the evaluation of IBS symptoms.
Participants/Inclusion and exclusion criteria
1)18-65 years 2) Patients with irritable bowel syndrome, according to gastroenterologist diagnosed according to the ROME- IV criteria 3) lack of any organic intestinal disease(diagnosed by last 5 years ago colonoscopy) and intestinal infections(diagnosed by stool culture). 4) No medical history of chronic gastrointestinal and colorectal disease Absence of any major bowel surgery 5) Absence of regular use of laxatives or antidiarrheal drugs
Intervention groups
Intervention group: will receive one synbiotic capsule containing Bacillus coagulans(0.1) g and inulin(0.9 g) per day plus low FODMAP diet for 8 weeks
Control: will receive low FODMAP diet and placebo for 8 weeks
Main outcome variables
Abdominal pain intensity, Abdominal pain frequency, Abdominal distension, Satisfaction with bowel habits, Interference with community function, Defecation frequency, Defecation consistency, Patient-rated Severity score, serum level of IL-6 and INF-ɣ
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100524004010N27
Registration date:2018-12-13, 1397/09/22
Registration timing:retrospective
Last update:2018-12-13, 1397/09/22
Update count:0
Registration date
2018-12-13, 1397/09/22
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-22, 1396/06/31
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of synbiotic supplements containing Bacillus coagulans and inulin with low FODMAP diet compared with low FODMAP diet alone on inflammatory factors, clinical outcomes and quality of life in patients with irritable bowel syndrome
Public title
Effect of Bacillus coagulans and inulin compared with low FODMAP diet in treatment of IBS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 years
Patients with irritable bowel syndrome, according to gastroenterologist diagnosed according to the ROME- IV criteria (1.Improvement with defecation 2.Onset associated with a change in stool frequency 3.Onset associated with a change in stool form (appearance) At least three days a month, three months a year and no pathological findings in the clinical investigating)
lack of any organic intestinal disease(diagnosed by last 5 years ago colonoscopy) and intestinal infections(diagnosed by stool culture).
No medical history of chronic gastrointestinal and colorectal disease
Absence of any major bowel surgery
Absence of regular use of laxatives or antidiarrheal drugs
No chronic use of antibiotics, corticosteroids and immunosuppressants
No usage of drugs that modifying the digestive motility such as metoclopramide, cisapride, diphenoxylate,…
No usage of drugs that increased bleeding of intestinal mucosa such as aspirin, warfarin, heparin,…
No history of breast cancer in patient or in first-degree relatives of a person
Absence of severe mental or behavioral disorder
Absence of nicotine and its derivatives use in last 6 monthsNo usage of NSAIDs and aspirin in last week(influence on gut permeability)
Exclusion criteria:
Life threatening symptoms
Death
Not agree to continue the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The method use in this study to create a randomization process is simple randomization, so we utilize random number table. Beginning of the study, each person is randomly assigned to one of the 2 study groups according to the randomized distribution table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci
Street address
West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb
City
Tehran
Province
Tehran
Postal code
193954741
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.SBMU.nnftri.Rec.1396.206
Health conditions studied
1
Description of health condition studied
Irritable Bowel Syndrom
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Abdominal pain intensity
Timepoint
Beginning and end of study
Method of measurement
Questionaire
2
Description
Abdominal pain frequency
Timepoint
Beginning and end of study
Method of measurement
Questionaire
3
Description
Abdominal distension
Timepoint
Beginning and end of study
Method of measurement
Questionaire
4
Description
Satisfaction with bowel habits
Timepoint
Beginning and end of study
Method of measurement
Questionaire
5
Description
Interference with community function
Timepoint
Beginning and end of study
Method of measurement
Questionaire
6
Description
Defecation frequency
Timepoint
Beginning and end of study
Method of measurement
Questionaire
7
Description
Defecation consistency
Timepoint
Beginning and end of study
Method of measurement
Questionaire
Secondary outcomes
1
Description
Patient-rated Severity score
Timepoint
Begining and end of the study
Method of measurement
Questionare
2
Description
IBS-SSS
Timepoint
Begining and end of the study
Method of measurement
Questionare
3
Description
IL-6
Timepoint
Begining and end of the study
Method of measurement
Enzymatic method using a kit
4
Description
INF-ɣ
Timepoint
Begining and end of the study
Method of measurement
Enzymatic method using a kit
Intervention groups
1
Description
Intervention group: will receive one synbiotic capsule containing Bacillus coagulans(0.1) g and inulin(0.9 g) per day plus low FODMAP diet for 8 weeks
Category
Treatment - Other
2
Description
Control group: will receive low FODMAP diet and placebo (starch) for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleqani Hospital
Full name of responsible person
Amir Sadeghi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
taleghanihospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb
City
Tehran
Province
Tehran
Postal code
00
Phone
+98 21 23871
Email
A_hekmat2000@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
West arghavan, Sanaat square, Farahzadi boulvard, Qods Town
City
Tehran
Province
Tehran
Postal code
00
Phone
+98 912 306 5084
Email
A_hekmat2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
West arghavan, Sanaat square, Farahzadi boulvard, Qods Town
City
Tehran
Province
Tehran
Postal code
00
Phone
+98 912 306 5084
Email
A_hekmat2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khadijeh Abhari
Position
Postdoctoral Fellowship
Latest degree
Ph.D.
Other areas of specialty/work
Food safety and Health
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
00
Phone
+98 917 303 2478
Email
m65abhari@gmail.com
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
Because the participant’s informations should remain confidental.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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