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Investigating the effect of probiotics compared to placebo on the clinical symptoms of children with eosinophilic gastroenteritis

Protocol summary

Study aim
Determining the effectiveness of probiotics on the clinical symptoms of children with eosinophilic gastroenteritis • Investigating and comparing the amount of gastrointestinal symptoms in children with eosinophilic gastroenteritis in the groups before and after the intervention. • Investigating and comparing the amount of endoscopic findings of children with eosinophilic gastroenteritis in the groups before and after the intervention.
Design
Clinical trial with two intervention groups, with parallel groups, double blind strain (patients, researcher), randomized, phase 2-3 on 50 patients, rand function of Excel software was used for randomization.
Settings and conduct
This study is an interventional, randomized, parallel, double-blind clinical trial on children aged 1-15 who presented with complaints of gastroenteritis. Patients will be placed in one of two study groups by stratified randomization method (first group: PPI and probiotic / second group: PPI and placebo). At the beginning and before the start of the studyand 10 weeks of treatment, the characteristics of endoscopic view, pathology and clinical symptoms of the patients will be recorded in a checklist and compared to the initial state.
Participants/Inclusion and exclusion criteria
Children aged 1 to 15 years with a definite diagnosis of eosinophilic gastroenteritis will be included in the study. Patients with immunodeficiency, history of eosinophilic disease, IBD, celiac disease, Crohn's disease and parasites, patients using corticosteroids/PPIs and antibiotics, and patients with poor drug compliance during treatment were excluded from the study.
Intervention groups
One group will receive PPI placebo and the other group will receive PPI and probiotics (in the form of cap. prokid).
Main outcome variables
Reduction of gastrointestinal symptoms and pathology in children with eosinophilic gastroenteritis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240419061527N1
Registration date: 2024-05-23, 1403/03/03
Registration timing: registered_while_recruiting

Last update: 2024-05-23, 1403/03/03
Update count: 0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Mahbube Koshkbaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7711 5857
Email address
mah_koshk@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-19, 1403/02/30
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of probiotics compared to placebo on the clinical symptoms of children with eosinophilic gastroenteritis
Public title
Investigating the effect of probiotics on the clinical symptoms of children with eosinophilic gastroenteritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of eosinophilic gastritis based on the following diagnostic criteria In pathological view ≥30 Eo/HPF in ≥5 HPF or ≥70 Eo/HPF in ≥3 HPF (stomach) ≥52 Eo/HPF (duodenum) ≥56 Eo/HPF (ileum) In endoscopic view: micronodules, erogenous and mucosal hyperemia Parents' consent to participate in the study
Exclusion criteria:
Non-compliance with the patient's medication Incompleteness of information Cortone/PPI/antibiotics use Patients with immune deficiency Other eosinophilic diseases such as IBD, celiac disease, parasitic diseases and Crohn's disease Cases of disturbed thyroid tests that require treatment
Age
From 1 year old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to experimental and control groups using the random block method. To perform randomization using quadruple blocks, first by throwing 16 regular hexagons 16 times, a random sequence of 16 quadruple blocks will be generated from the following blocks: AABB-ABAB-ABBA-BAAB-BABA-BBAA In the sequence, there will be 25 of each letter A and B. According to the above block, 50envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 50 . The person delivering the envelopes to the patients does not know the letters inside. Randomization is done by a statistics and methodology consultant who does not have access to patients and only he knows what is in each envelope. Patients who received the letter A will be in the Probiotic group and patients who received the letter B will be in the plasebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
After assigning the patients randomly, two groups of patients will use the same medicine with the same packaging and they will not know the type of treatment received.The researcher who evaluates the symptoms and recovery of the patients also does not know the type of treatment received by the patient.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
13th Floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., Quds (West) City, Tehran
City
Tehran
Province
Tehran
Postal code
Approval date
2024-01-21, 1402/11/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.587

Health conditions studied

1

Description of health condition studied
Eosinophilic gastroenteritis
ICD-10 code
K52.81
ICD-10 code description
Eosinophilic gastritis or gastroenteritis

Primary outcomes

1

Description
Improving digestive symptoms (abdominal pain, diarrhea, nausea and vomiting, and constipation)
Timepoint
At the beginning of the study and 10 weeks after the start of treatment
Method of measurement
Check clinical symptoms by asking the patient and family

2

Description
The recovery rate in the endoscopic view (number of micronodules, number of erogenous and mucosal hyperemia)
Timepoint
At the beginning of the study and 10 weeks after the start of treatment
Method of measurement
Based on endoscopy and gastroenterologist diagnosis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: PPI and probiotic recipients (one daily Prokid capsule)
Category
Treatment - Drugs

2

Description
Control group: PPI and placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Bahrami Children's Hospital
Full name of responsible person
Dr.Kambiz Eftekharian
Street address
Unit 10, 2nd floor, Plate 9, Matin Complex, Tawanir Square (Shaheed Abbaspour)
City
Tehran
Province
Tehran
Postal code
1434783341
Phone
+98 914 423 0790
Email
K-eftekhari@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Rezaei
Street address
Faculty of Medicine, Porsina St., Quds St., Elginal St
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 921 518 5650
Email
rezaei_nima@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Kambiz Eftekharian
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Bahrami Hospital, Ansar Al Hossein Street, Shahid Kiaei Street (Qasim Abad), Damavand Street, Tehran
City
Tehran
Province
Tehran
Postal code
1434783341
Phone
+98 21 6739 5090
Email
k-eftekhari@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahbube Koshkbaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 22, Nastern 22 Ave, Shahid Beheshti Blvd, Shahid Babaei highway, Tehran Town
City
Tehran
Province
Tehran
Postal code
1434783341
Phone
+98 21 7711 5857
Fax
Email
mah_koshk@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahbube Koshkbaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 22, Nastern 22 Ave, Shahid Beheshti Blvd, Shahid Babaei highway, Tehran Town
City
Tehran
Province
Tehran
Postal code
1434783341
Phone
+98 21 7711 5857
Fax
Email
mah_koshk@yahoo.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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Dr. Mahbobeh Koshk Baghi, pediatric specialist assistant, project manager, contact number: 09120276033 and email: mah_koshk@yahoo.com
What processes are involved for a request to access data/document
The applicant should provide a description of her study and the purpose of receiving the data in an email format along with her research file (research plan), then after a period of 3 months, the file will be provided to the individual
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