]>
IRCT20200504047303N1 IRCT 2020-05-16 Genetics Pharma PVT Comparing Lactobacillus plantarum 299v with Placebo in treating irritable bowel syndrome patients RCT in IBS A Double Blind Randomized Clinical Trail: Comparing Lactobacillus plantarum 299v with Placebo in treating irritable bowel syndrome patients 2635-10-10 anticipated 190 Pending https://irct.ir/trial/48046 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: NA, Randomization description: After fulfilling the inclusion criteria for the study and signing the informed consent form the randomization was started by lottery method and then patients were alternatively allotted to either of the two groups, Blinding description: The study drug containing 5x1010 cfu of L.Plantarum 299v and the placebo containing micro-crystalline cellulose powder, both were packed in the similar packing by the manufacturers (Genetex Pharma PVT Limited). The study drug was labeled A and the placebo as B, it was disclosed at the end of the study. N/A irritable bowel syndrome. Intervention 1: Intervention group: Patients enrolled suffering from IBS were divided in two groups Group A received Lactobacillus plantarum 299v. Intervention 2: Control group: Patients enrolled suffering from IBS were divided in two groups Group B received Placebo. Yes - There is a plan to make this available What will be shared: In the form of publish article When: In the form of publish article as soon as the article publish To whom: To all Conditions: would be freely available for download Where to obtain: on request from corresponding author How to obtain: email to the corresponding author Comments: This retrospective trial registration
public Dr Muhammad Kamran Hassan
Lady Reading Hospital, Peshawar
Peshawar Pakistan 45000 +92 91 9211430 drkamran177@yahoo.com Lady Reading Hospital, Peshawar scientific Dr Muhammad Kamran Hassan
Lady Reading Hospital Peshawar
Peshawar Pakistan 45000 +92 91 9211430 drkamran177@yahoo.com Lady Reading Hospital Peshawar Pakistan Fulfilling the Rome III criteria for IBS Willing to participate Committed for follow up throughout the study period 18 years no limit Both History of major abdominal surgery, Organic intestinal disease or chronic infectious disease like HIV or tuberculosis Pregnant and the female breastfeeding their babies Anyone with current use of antibiotics K58 Irritable bowel syndrome Treatment - Drugs Placebo Intervention group: Patients enrolled suffering from IBS were divided in two groups Group A received Lactobacillus plantarum 299v. Control group: Patients enrolled suffering from IBS were divided in two groups Group B received Placebo Symptomatic treatment with out Lactobacillus plantarum 299v. Timepoint: conducted for six (6) months. Method of measurement: Daily frequency of abdominal pain was considered as primary end point. The secondary end points were improvement in the severity of abdominal pain, severity of the bloating and feeling of partial rectal emptying. Both the primary and the secondary end points were gauged on the visual analogue scale from zero (0) to ten (10), 0 being normal and 10 being very severe. In each visit the patients were examined thoroughly and all the parameters were noted along with the medication compliance. NA Approved 2635-10-10 Institutional Research and Ethics Board of Lady Reading Hospital Peshawar Lady Reading Hospital Peshawar Peshawar KPK Pakistan