Protocol summary

Study aim
Effect of probiotic supplementation on severity and frequency of migraine in patients with irritable bowel syndrome (IBS) visited in gastroenterology clinic.
Design
Participants enter the study based on inclusion and exclusion criteria. Then based on characteristics of disease in individuals, participants are divided into two groups of IBS-constipation dominant or IBS-C for short and IBS-diarrhea dominant or IBS-D for short. Then each of these groups are randomized into two groups with equal number of patients, called "control" and "intervention". This randomization is double-blinded is done on 132 participants (33 for each group mentioned above).
Settings and conduct
This study takes place in gastroenterology clinic in Valiasr hospital in Zanjan. The physician and participants are blinded and drugs are labeled.
Participants/Inclusion and exclusion criteria
Participants are to be older than 18 years of age. Criteria of inclusion are as followed: confirmed both migraine and IBS. Criteria of exclusion are: diseases of gastrointestinal tract other than IBS, headaches classified other than migraine, having absolute contraindications for selective norepinephrine-serotonin reuptake inhibitor (SNRI) or tricyclic antidepressant (TCA) according to intervention group, consumption of antibiotics during study and patients whose IBS classification is other than irritable bowel syndrome with diarrhea (IBS-D) or irritable bowel syndrome with constipation (IBS-C).
Intervention groups
IBS-C intervention group IBS-C control group IBS-D intervention group IBS-D control group IBS patients are divided to two groups of diarrhea- and constipation-dominant based on disease characteristics because these two groups receive different types of treatment.
Main outcome variables
Severity and frequency of migraine and severity of IBS

General information

Reason for update
Acronym
IBS= irritable bowel syndrome
IRCT registration information
IRCT registration number: IRCT20101209005352N5
Registration date: 2024-04-09, 1403/01/21
Registration timing: registered_while_recruiting

Last update: 2024-04-09, 1403/01/21
Update count: 0
Registration date
2024-04-09, 1403/01/21
Registrant information
Name
Mehdi Maghbooli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2576
Email address
m.maghbooli@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic supplementation on frequency and severity of migraine among IBS patients visited in gastroenterology clinic
Public title
Probiotic effects in migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed migraine by ICHD3 criteria Confirmed IBS by Rome IV criteria
Exclusion criteria:
Affliction to gastrointestinal diseases other than IBS Affliction to neurologic diseases or headaches other than migraine Patients not referring to clinic after first visit IBS-D patients with contraindication to TCA IBS-C patients with contraindication to SNRI IBS patients not classified as IBS-C or IBS-D Consumption of antibiotics of any kind during study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
In this study patients visited in gastroenterology clinic who have both IBS and migraine, are divided to two groups using stratified sampling technique. These groups are named IBS-C (constipation-dominant) and IBS-D (diarrhea-dominant) and then using individual randomization technique each of these groups are divided into two groups of "intervention" and "control".
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind in a way that only the investigator has the information about placebo and drug itself. Placebo and drug packaging are coded with random numbers indicating placebo or drug. At the phase of gathering information, placebo or drugs are decoded and thus data is analyzed.
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of medical sciences
Street address
Valiasr hospital, Valiasr sq., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Approval date
2023-10-31, 1402/08/09
Ethics committee reference number
IR.ZUMS.REC.1402.182

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine

2

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

Primary outcomes

1

Description
Migraine severity
Timepoint
Severity of migraine is measured at day 0 and 90 of the trial.
Method of measurement
Migraine severity is evaluated by Visual Analogue Scale.

2

Description
Migraine frequency
Timepoint
Weekly
Method of measurement
Episodes of headache per week

3

Description
IBS severity
Timepoint
Severity of IBS is measured at day 0 and 90 of the trial.
Method of measurement
Visual Analogue Scale from 1 to 10

4

Description
Number of analgesics consumed per week
Timepoint
Weekly
Method of measurement
Number of analgesics

5

Description
Aura
Timepoint
Migraine aura is determined at the first visit.
Method of measurement
Presence or absence of aura.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: IBS with Constipation. Patients in this group receive Venlafaxine 37.5 mg tablet daily plus probiotic capsule with Familact brand name which is the product of Zist Takhmir company. Patients must take these medications for 90 days.
Category
Treatment - Drugs

2

Description
Intervention group: IBS with Diarrhea. Patients in this group receive Amitriptyline 10 mg tablet daily plus probiotic capsule with Familact brand name which is the product of Zist Takhmir company. Patients must take these medications for 90 days.
Category
Treatment - Drugs

3

Description
Control group: IBS with Diarrhea. Patients in this group receive a 90-day regimen of one Amytriptyline 10mg tablet plus a placebo capsule which is produced by Zist Takhmir company. This placebo has the adequate standards and does not cause gastrointestinal side effects.
Category
Placebo

4

Description
Control group: IBS with Constipation. Patients in this group receive a 90-day regimen of one Venlafaxine 37mg tablet plus a placebo capsule which is produced by Zist Takhmir company. This placebo has the adequate standards and does not cause gastrointestinal side effects.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology clinic of Valiasr hospital in Zanjan
Full name of responsible person
Dr. Mahdi Maghbooli
Street address
Valiasr Sq.
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3373 9011
Email
valiasr@zums.ac.ir
Web page address
https://zums.ac.ir/content/48870/%D8%AA%D9%85%D8%A7%D8%B3-%D8%A8%D8%A7-%D9%85%D8%B1%DA%A9%D8%B2

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nadri
Street address
Zanjan University of Medical Sciences, Azadi Blvd. , Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6141
Fax
+98 24 3342 0460
Email
research@zums.ac.ir
Web page address
http://research.zums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Maghbooli
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of neurology, Valiasr hospital, Valiasr Sq., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3373 9011
Email
m.maghbooli@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahdi Maghbooli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Vali-e-Asr hospital, Vali-e-Asr Squ.
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
009824770801
Email
m.maghbooli@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehdi Maghbooli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Vali-e-Asr hospital, Vali-e-Asr Squ.
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
009824770801
Email
m.maghbooli@zums.ac.ir

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
Not applicable
Title and more details about the data/document
All data will be published after anonymization.
When the data will become available and for how long
For 2 years after publication
To whom data/document is available
Researchers in academic positions
Under which criteria data/document could be used
without any limitations
From where data/document is obtainable
Dr. Mehdi Maghbooli m.maghbooli@zums.ac.ir 0989144910131 Neurology department, Valiasr hospital, Zanjan, Iran Ali Hajipour ahajipour7773@gmail.com 0989147632385 14, Kalantar Ave., Tabriz, Iran
What processes are involved for a request to access data/document
ID about one week
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