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A double-blind randomized clinical trial for the effectiveness of rectal enema containing a probiotic strain of Bifidobacterium longum in children with distal ulcerative colitis

Protocol summary

Study aim
The effect of rectal enema containing a probiotic strain, Bifidobacterium longum, in children with ulcerative colitis
Design
A double-blinded, randomized (Using block randomization), sham-controlled clinical trial with a parallel group design will be done on 60 patients.
Settings and conduct
Eligible patients in Namazi hospital and Imam Reza clinic will be admitted. After randomization, they will be divided into 2 groups and receive a drug or placebo for 8 weeks. Physicians, researchers, and patients will be unaware of the enema content and only the producer knows it. During and at the end of the trial, patients will be evaluated for PUCAI, laboratory findings, and adverse effects.
Participants/Inclusion and exclusion criteria
Patients between 4-20 years will be admitted to the study, who had a confirmed diagnosis of acute UC with mild to moderate disease activity (PUCAI=10-64). Exclusion criteria include: Crohn's disease Infectious colitis or other causes of colitis such as medical drugs, radiation, ischemia of affected intestinal segments Participation in another clinical trial either simultaneously or within 30 days prior to enrolment Use of antibiotics or sulfonamides within or 2 weeks prior to the study Lack of cooperation, neurotic personality, and obesity History of stool incontinence, perianal fistulae, major colonic surgery, colorectal carcinoma, or stenosis Ill patients who are unable to cooperate & the patients suspicious to toxic megacolon
Intervention groups
The intervention group receives 40 ml rectal enema containing probiotics along with standard therapy with oral mesalazine. The control group receives an identical enema preparation devoid of the active substance (probiotics) as a placebo.
Main outcome variables
Number of patients who are in remission or experience clinical response after trial

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130514013321N3
Registration date: 2023-07-09, 1402/04/18
Registration timing: registered_while_recruiting

Last update: 2023-07-09, 1402/04/18
Update count: 0
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
Ahmad Gholami
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1242 4255
Email address
gholami@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double-blind randomized clinical trial for the effectiveness of rectal enema containing a probiotic strain of Bifidobacterium longum in children with distal ulcerative colitis
Public title
Probiotic rectal enema in ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children at age of 4-20 definite diagnosis of ulcerative colitis by colonoscopy and histology with disease severity of mild to moderate at least 2 confirmed prior manifestations of the disease
Exclusion criteria:
Infectious colitis or other causes of colitis such as medical drugs, radiation, ischemia of affected intestinal segments Crohn's disease Participation in another clinical trial either simultaneously or within 30 days prior to enrolment a lack of cooperation, neurotic personality, and obesity A history of stool incontinence, perianal fistulae, major colonic surgery, colorectal carcinoma, or or stenosis Ill patients who are unable to cooperate & the patients suspicious to toxic megacolon
Age
From 4 years old to 20 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using block randomization with block size:4, blocked tables are determined priorly by computer software and patients will be added to the table according to the sequence of enrollment into the study and will be allocated to groups A or B. Also, they receive a number according to the table. The producer group allocates group A or B to the "drug" or "placebo" group but they don't reveal this matter until the end of the study. Delivery of the drug or placebo to the patients will be done based on the received number by each patient, so the researcher, physician, and patient are unaware of the content.
Blinding (investigator's opinion)
Double blinded
Blinding description
Eligible patients will be enrolled and randomized to treatment with either 40ml probiotics or a placebo. Patients will receive a number and will to allocated to groups A or B using a predetermined block randomization table and the order of enrolment. The producer group allocates group A or B to the "drug" or "placebo" group but they don't reveal this matter until the end of the study. Delivery of the drug or placebo to the patients will be done based on the received number by each patient. Therefore blinding of the investigator, physician, and patient will be ensured by the provision of study medication identical in appearance, and a patient-specific number.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shiraz university of medical sciences
Street address
Administration Building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
IR.SUMS.MED.REC.1402.080

Health conditions studied

1

Description of health condition studied
ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
Number of patients who are in clinical remission after the trial
Timepoint
َAt the begining of study, at the physician visits in weeks 2, 4 and 8 & patient self-reported questionnares in weeks 1,3,5,6 and 7
Method of measurement
Assessment of PUCAI by questionnaire (Clinical remission defined as PUCAI less than 10)

2

Description
Number of patients who experience clinical response after the trial
Timepoint
َAt the physician visits on weeks 2, 4 and 8 & patient self-reported questionnares in weeks 1,3,5,6 and 7
Method of measurement
Assessment of PUCAI by questionnaire (Clinical response defined as changes in PUCAI more than or equal to 20 or achievement of clinical remission)

Secondary outcomes

1

Description
Changes in the level of stool calprotectin
Timepoint
At the physician visits in weeks 2, 4, and 8
Method of measurement
Stool sample

2

Description
Changes in the level of inflammatory factors (ESR, CRP)
Timepoint
At the physician visits in weeks 2, 4, and 8
Method of measurement
Blood sample

3

Description
Extraintestinal manifestations
Timepoint
At the physician visits in weeks 2, 4, and 8
Method of measurement
Questionnaire

4

Description
Global health assessment by the physician
Timepoint
At the physician visits in weeks 1, 2, and 8
Method of measurement
questionnaire (6-point scale)

Intervention groups

1

Description
Intervention group: The investigational drug contains probiotic, non-pathogenic Bifidobacterium longum. (108 viable microorganisms per ml). Other components are purified water, sodium chloride, potassium chloride, magnesium sulfate, and magnesium chloride. 40 ml drug is administered as an enema at 10 o'clock. The patients receive the enema along with the standard therapy with oral mesalazine.
Category
Treatment - Drugs

2

Description
Control group: As placebo an identical enema preparation devoid of the active substance, will be used. The patients receive the enema along with the standard therapy with oral mesalazine.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr. Naser Honar
Street address
Namazi hospital, Namazi square, Zand steet, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
nemazee_inf@sums.ac.ir
Web page address
https://namazi.sums.ac.ir/

2

Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Dr. Naser Honar
Street address
Imam Reza clinic, Namazi square, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir
Web page address
https://emamreza.sums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempur
Street address
Administration Building of Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://www.sums.ac.ir/
Grant name
Grant code / Reference number
27047
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ahِmad Gholami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, Karafarin avenue
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 1242 4255
Fax
+98 71 1242 4881
Email
gholami@sums.ac.ir
Web page address
https://pharmacy.sums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ahmad Gholami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, Karafarin avenue
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 1242 4255
Fax
+98 71 1242 4881
Email
gholami@sums.ac.ir
Web page address
https://pharmacy.sums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ahmad Gholami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, Karafarin avenue
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 1242 4255
Fax
+98 71 1242 4881
Email
gholami@sums.ac.ir
Web page address
https://pharmacy.sums.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The obtained data and the reports will be written, revised, and submitted to a peer-reviewed international journal after completing the clinical trial. The data files will be available 6 months after publication in valid international journals only for the people working in academic and scientific centers by sending an email to Dr. Saeideh Mohammadi (student researcher)
When the data will become available and for how long
The data files will be available 6 months after publication
To whom data/document is available
The data are available only for the people working in academic and scientific centers
Under which criteria data/document could be used
Repeated measure analysis of findings to evaluate the effects of the drug in longer periods of time and more detailed studies, as well as systematic reviews
From where data/document is obtainable
by sending an e-mail to Dr.Saeideh Mohammadi email address: mohammadi.saeideh2018@gmail.com
What processes are involved for a request to access data/document
The request will be responded 1 week after sending an email to Dr. Saeideh Mohammadi
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