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IRCT20181231042191N1 IRCT 2019-04-18 Islamic Azad University probiotics in Irritable bowel syndrome Effect of multispecies probiotic supplementation on Irritable bowel syndrome 2019-04-20 anticipated 50 Complete https://irct.ir/trial/38728 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The following clinical trial will be Double Blind Randomized Placebo-controlled. In this clinical trial study, the sample size is estimated to be 50, which will eventually be 25 in the intervention group and 25 in the control group. Samples will be selected from among the referrals to the gastroenterology clinic of Ayatullah Golpayegani Qom Hospital.Packages of products will be encoded in two types by the company; a code for the original drug and a code for the placebo. Each of the two groups that are randomly assigned will receive a type of drug code. The codes are kept secret from patients and researchers, and will be announced to the researchers at the end of the study after the completion of the clinical trial, Blinding description: The following clinical trial will be Double Blind Randomized Placebo-controlled. In this clinical trial study, the sample size is estimated to be 50, which will eventually be 25 in the intervention group and 25 in the control group. Blocked randomization method is considered for this study. In this way, the first eligible patient is assigned to the Group A and the second one to the Group B, and so the rest of the patients are divided between the two groups one after the another. 3 Irritable bowel syndrome. Intervention 1: Intervention group: Patients will receive two 500 mg Familact® probiotic capsules, produced by Tehran Zisttakhmir Company, daily for 30 consecutive days. To maximize absorption, the time of medication taking will recommended between each meal. The count of the Familact production is {10}^9 CFU and contains Lactobacillus casei، Lactobacillus acidophilus، Lactobacillus rhamnosus، Lactobacillus bulgaricus ،Bifidobacterium breve، Bifidobacterium longum، Streptococcus thermophilus and Fructooligosaccharides (FOS). Intervention 2: Control group: Patients will receive two 500 mg placebo capsules daily for 30 consecutive days. Capsules contain an inert substance that are designed and manufactured with the same appearance and packaging as the original and unidentifiable for the patients and researchers by the company( Tehran Zisttakhmir Company). As it is indistinguishable with the original drug, the time of medication taking will recommended just similar to the original drug, between each meal. Yes - There is a plan to make this available What will be shared: SPSS data file with unidentifiable personal data will be available for applicant researchers, after completion and publication of this study When: Start the access period after official publication of the results To whom: Both researchers and related industries Conditions: Any kind of scientific, practical and research use by informing and obtaining consent from researchers is allowed. Where to obtain: refer to project researchers Email address: mersadamery@yahoo.com How to obtain: By sending a request in the email; providing the full details of identification including name and membership number in the scientific, research or industrial reference, and a full explanation of the type of use of the data and their goals. Comments:
public Mersad Amery
No. 15, 29 Ave.,15 Khordad Blvd
Qom Iran (Islamic Republic of) 3714685644 +98 25 3778 7610 mersadamery@yahoo.com Islamic Azad University scientific Mersad Amery
No. 15, 29 Ave.,15 Khordad Blvd
Qom Iran (Islamic Republic of) 3714685644 +98 25 3778 7610 mersadamery@yahoo.com Islamic Azad University Iran (Islamic Republic of) Patients will be selected based on the Rome II criteria according to the gastroenterologist diagnosis ; (Rome II criteria: abdominal pain or any digestive discomfort for at least 3 months during the last year that can be consecutive or non-consecutive, along with two of the three following items: relieving pain by defecation, starting symptoms associated with change in the frequency of bowel movements, starting symptoms associated with change in the shape of feces) Age of at least 18 years old The informed consent of the patient, which is submitted in writing form after all necessary explanations are given to him/her. 18 years no limit Both History of major gastrointestinal surgery chronic use of antibiotics, corticosteroids and immunosuppressive drugs Regular use of drugs that alter gastrointestinal movements such as metoclopramide, cisapride, domperidone, narcotics especially opioid derivatives, laxatives, anti-diarrheal agents, as well as other effective drugs for the treatment of IBS, as described in more detail in the text. Presence of severe psychological and behavioral disorders in the patient Food allergy History of any organic bowel disease or chronic digestive illness K58 Irritable bowel syndrome Treatment - Drugs Placebo Intervention group: Patients will receive two 500 mg Familact® probiotic capsules, produced by Tehran Zisttakhmir Company, daily for 30 consecutive days. To maximize absorption, the time of medication taking will recommended between each meal. The count of the Familact production is {10}^9 CFU and contains Lactobacillus casei، Lactobacillus acidophilus، Lactobacillus rhamnosus، Lactobacillus bulgaricus ،Bifidobacterium breve، Bifidobacterium longum، Streptococcus thermophilus and Fructooligosaccharides (FOS). Control group: Patients will receive two 500 mg placebo capsules daily for 30 consecutive days. Capsules contain an inert substance that are designed and manufactured with the same appearance and packaging as the original and unidentifiable for the patients and researchers by the company( Tehran Zisttakhmir Company). As it is indistinguishable with the original drug, the time of medication taking will recommended just similar to the original drug, between each meal. Severity of abdominal pain: discrete quantitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: The questionnaire (numbers from 0 to 10 to assess the severity of the abdominal pain; zero indicates no pain and 10 indicates pain is very severe). Amount of abdominal discomfort: discrete quantitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: The questionnaire (numbers from 0 to 10 to assess the amount of the abdominal discomfort; zero indicates no discomfort and 10 indicates very severe discomfort). Amount of bloating and/or abdominal swelling: discrete quantitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: The questionnaire (numbers from 0 to 10 to assess the amount of the bloating and/or abdominal swelling; zero indicates no bloating and/or abdominal swelling and 10 indicates bloating and/or abdominal swelling is very severe). Heartburn: Nominal qualitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: Questionnaire (has / not). Nausea: Nominal qualitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: Questionnaire (has / not). The bowel habits (in terms of frequency of defecation and stool consistency) than before the onset of treatment: Nominal qualitative dependent variable. Timepoint: At the end of the study (end of the intervention). Method of measurement: Questionnaire (worse / no change / better). Improvement of overall IBS symptoms than before starting the treatment: Nominal qualitative dependent variable. Timepoint: At the end of the study (end of the intervention). Method of measurement: Questionnaire (Yes / No). Quality of patients' lives: Nominal qualitative dependent variable. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (end of the intervention). Method of measurement: IBS-QOL questionnaire. Islamic Azad University Approved 2018-11-06 Ethics Committee of Islamic Azad University of Qom Medical College, 15 Khordad Blvd Qom Ghoum Iran (Islamic Republic of)