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IRCT20100524004010N45 IRCT 2026-05-30 Shahid Beheshti University of Medical Sciences The effect of Lactobacillus paracasei post biotic combination with low FODMAP diet on ulcerative colotis The effect of Lactobacillus paracasei post biotic combination with low FODMAP diet on quality of life, disease activity index and serum level of some inflammatory factors in patients with active mild to moderate ulcerative colitis. 2026-05-22 anticipated 22 Complete https://irct.ir/trial/90011 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to two treatment groups and a control group using a randomized block allocation method. One group is given a postbiotic capsule and the control group is given a placebo. These two groups are poured into identical containers by someone other than the researchers and labeled A and B on the containers. The researchers will not know about this grouping until the end of the study. For this purpose, patients are classified based on BMI and gender, which are confounding factors that we want to be similar between the two groups, and then we randomly assign individuals in each category to the dietary supplement group and the placebo group according to blocks of 6. This method makes the two study groups similar in terms of gender, Blinding description: Patients won’t know if they are receiving the postbiotic or a placebo for double-blinding the study, the bottles containing the relevant capsules will be concealed as A and B by a third person at the beginning of the study, and none of the research team members will know the type of capsule received by each group. 3 ulcerative colitis. Intervention 1: Intervention group: 50 mg postbiotic supplement with concentration of 10000000000 /gr per day.The supplement is produced in National Nutrition & Food Technology Research Institute, and encapsulated. The patient should take one capsule per day with breakfast. Intervention 2: Control group: 50 mg placebo containing maltodexterin. The supplement is encapsulated in capsules similar to supplements. The patient should take one capsule per day with breakfast. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not yet decided how to share the final data.
public Azita Hekmatdoost
No 7, Shahid Hafezi Ave, Farahzadi Blvd, Western Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No 7, Shahid Hafezi Ave, Farahzadi Blvd, Western Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2293 0824 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Samples' inflammatory bowel disease should be confirmed Histopathologically The duration of the disease should be less than two years. The disease should be mild to moderate (the severity of the disease is determined by the treating physician). Patient's BMI should be above 18.5 and below 30 Willingness to collaborate in this project Age18 and more 18 years no limit Both Recurrence of the disease in a way that leads to hospitalization of the person. Having other diseases such as billiary disease, kidney disease, known autoimmune diseases, cancer, and liver disorders Presence of an abdominal abscess or fistula History of ileostomy and colostomy Pregnancy or breastfeeding in women or use contraceptives History of enteral or parenteral nutrition Fiber, omega-3, and antioxidant supplement consumption in the past 3 months Following special diet and vegan diet within the past 3 months multivitamin mineral and probiotic supplements consumption Anticoagulants such as heparin and warfarin, nonsteroidal anti-inflammatory drugs such as ibuprofen, aspirin and diclofenac, antihistamines and calcium channel antagonists such as nifedipine consumption within the past 1 month Change in the type and dose of medication taken within the past 1 month Alcohol and drug abuse K51.9 Ulcerative colitis, unspecified Treatment - Drugs Placebo Intervention group: 50 mg postbiotic supplement with concentration of 10000000000 /gr per day.The supplement is produced in National Nutrition & Food Technology Research Institute, and encapsulated. The patient should take one capsule per day with breakfast. Control group: 50 mg placebo containing maltodexterin. The supplement is encapsulated in capsules similar to supplements. The patient should take one capsule per day with breakfast. TNF-α. Timepoint: At the first of research and end of research( 8th week). Method of measurement: Elisa. Life Quality. Timepoint: At the first of research and end of research( 8th week). Method of measurement: IBDQ-9 Questionnaire. Disease Activity Index. Timepoint: At the first of research and end of research( 8th week). Method of measurement: Questionnaire. Weight. Timepoint: At the first of research and end of research( 8th week). Method of measurement: scale. BMI. Timepoint: At the first of research and end of research( 8th week). Method of measurement: Calculation. Hs-CRP. Timepoint: At the first of research and end of research( 8th week). Method of measurement: ELISA kit. TAC. Timepoint: At the first of research and end of research( 8th week). Method of measurement: ELISA. Shahid Beheshti University of Medical Sciences Approved 2026-04-18 Ethics Committee of National Nutrition and Food Technology Research Institute (NNFTRI) #7, Shahid Hafezi Ave, Farahzadi Blvd, Shahrak Gharb Tehran Tehran Iran (Islamic Republic of)