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IRCT20230105057061N1 IRCT 2023-08-22 Islamic Azad University Encapsulation of Lactobacillus rhamnosus bacteria Encapsulation of Lactobacillus rhamnosus probiotic bacteria by electrospinning method using ploy di actelene polymer. 2023-05-02 anticipated 25 Complete https://irct.ir/trial/72092 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial study, the sample size is estimated to be 50 people, and finally 25 people will be in the intervention group and 25 people will be in the control group. The samples will be selected from among those who visit the gastroenterology clinic of Khorrami (Hazrat Masoumeh) and Shahid Beheshti Hospitals in Qom. Product packaging will be coded by the company in two ways. Each of the two randomly divided groups will receive a type of drug code. The codes are kept secret by the company from the patients and researchers and will be announced to the researchers at the end of the study after the completion of the clinical trial by the company, Blinding description: The upcoming clinical trial will be conducted in a randomized, double-blind, placebo-control group. In this clinical trial study, the sample size is estimated to be 50 people, and finally 25 people will be in the intervention group and 25 people will be in the control group. Blocked randomization method is considered for this study. In this way, the first qualified patient enters group A and the second one enters group B, and in the same way, the rest of the patients are divided between the two groups one after the other. 0 (exploratory trials) Constipation and gastrointestinal cancer. Intervention 1: Control group: patients for 30 consecutive days, daily two 500 mg capsules of placebo containing an ineffective substance with the same shape and appearance and packaging as the original drug and unrecognizable to patients and researchers by the company (Danish Biopharmaceutical Company, (Tehran) designed and produced will consume. Since it is indistinguishable from the original drug, it is recommended to take it at the same time as the original drug, between each meal. Intervention 2: Control group: use of dietary supplements Figilax and Fitolax as well as folic acid and zinc in a period of 90 days. Yes - There is a plan to make this available What will be shared: SPSS file data by de-identifying individual characteristics after The completion and printing of this study will be available to the applicant researchers took When: The access period starts after the results are printed To whom: Both researchers and related industries Conditions: Any kind of scientific, practical and research use with awareness and acquisition Consent from researchers is allowed. Where to obtain: Refer to the researchers of the project, e-mail: qashamzadeh1399@gmail.com How to obtain: While sending the request by email, complete identification information including name and Surname and membership number in a scientific, research or industrial authority and Provide a full explanation of the type of data use and its purposes to do Comments:
public Islamic Azad University
Pardisan St, Islamic Azad University, Qom branch
Qom Iran (Islamic Republic of) 3749113191 +98 25 3280 8080 qom@cms.iau.ir Islamic Azad University scientific Dr. Mohammad Dakhili Ranj Jo
Pardisan Blvd, Islamic Azad University, Qom branch
Qom Iran (Islamic Republic of) 3749113191 +98 25 3280 8080 dr_dakhili@yahoo.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) The main conditions for entering the study before randomization: patients will be selected based on the Rome II criteria according to the diagnosis of digestive and liver diseases; (Rome II criteria: abdominal pain or any digestive discomfort for at least 3 months during a year) The past three months can be consecutive or non-consecutive, along with two of the following three: resolution of pain with defecation, onset of symptoms with change in frequency of defecation, onset of symptoms with change in stool shape) minimum age 18 years of informed consent of the patient, which is adopted in writing after providing all the necessary explanations for them. 9 years 80 years Male The main conditions of non-entry into the study before randomization: a history of major gastrointestinal surgery, chronic use of antibiotics, corticosteroids, and immunosuppressive drugs, regular use of drugs that change the movements of the digestive system, such as metoclopramide, cisapride, domperidone, narcotics, especially Opioid derivatives, laxative agents, antidiarrheal agents, and other drugs effective in the treatment of IBS, which are described in more detail in the text. The presence of severe mental and behavioral disorders in the patient, the presence of food allergies, the presence of any organic intestinal disease or chronic digestive disease C26.9 Gastrointestinal tract NOS Placebo Placebo Control group: patients for 30 consecutive days, daily two 500 mg capsules of placebo containing an ineffective substance with the same shape and appearance and packaging as the original drug and unrecognizable to patients and researchers by the company (Danish Biopharmaceutical Company, (Tehran) designed and produced will consume. Since it is indistinguishable from the original drug, it is recommended to take it at the same time as the original drug, between each meal. Control group: use of dietary supplements Figilax and Fitolax as well as folic acid and zinc in a period of 90 days Abdominal pain intensity. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (the end of the intervention) during the intervention and 3 months after the intervention. Method of measurement: Questionnaire (numbers 0 to 10 to check pain intensity, where 0 represents the absence of pain and 10 represents very intense pain). . Timepoint: . Method of measurement: . Albumin and pre-albumin. Timepoint: Before the intervention, during the intervention and 3 months after the intervention. Method of measurement: Laboratory kits. Alkaline phosphatase. Timepoint: Before the intervention, during the intervention and 3 months after the intervention. Method of measurement: Laboratory kits. Alanine aminotransferase. Timepoint: Before the intervention, during the intervention and 3 months after the intervention. Method of measurement: Laboratory kits. Erythrocyte sedimentation rate (ESR). Timepoint: Before the intervention, during the intervention and 3 months after the intervention. Method of measurement: Laboratory kits. Islamic Azad University Approved 2023-04-11 Ethics Committee of Islamic Azad University Qom branch Islamic Azad University, Qom branch, 15 Khordad Blvd. Qom Ghoum Iran (Islamic Republic of)