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IRCT20130514013321N3 IRCT 2023-07-09 Shiraz University of Medical Sciences Probiotic rectal enema in ulcerative colitis 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 2023-06-22 anticipated 60 Complete https://irct.ir/trial/64879 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 ulcerative colitis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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 files will be available 6 months after publication To whom: The data are available only for the people working in academic and scientific centers Conditions: 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 Where to obtain: by sending an e-mail to Dr.Saeideh Mohammadi email address: mohammadi.saeideh2018@gmail.com How to obtain: The request will be responded 1 week after sending an email to Dr. Saeideh Mohammadi Comments:
public Dr. Ahِmad Gholami
School of Pharmacy, Karafarin avenue
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 1242 4255 gholami@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Ahmad Gholami
School of Pharmacy, Karafarin avenue
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 1242 4255 gholami@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 4 years 20 years Both 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 K51 Ulcerative colitis Treatment - Drugs Placebo 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. 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. 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). 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). Changes in the level of stool calprotectin. Timepoint: At the physician visits in weeks 2, 4, and 8. Method of measurement: Stool sample. 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. Extraintestinal manifestations. Timepoint: At the physician visits in weeks 2, 4, and 8. Method of measurement: Questionnaire. Global health assessment by the physician. Timepoint: At the physician visits in weeks 1, 2, and 8. Method of measurement: questionnaire (6-point scale). Shiraz University of Medical Sciences Approved 2023-05-29 Ethics committee of shiraz university of medical sciences Administration Building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)