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IRCT20080921001264N12 IRCT 2023-01-24 Gorgan University of Medical Sciences Evaluating the effect of administration of Lactocare® probiotic on gasterointestinal symptoms and Anti-Ttg antibody in patients with celiac disease: Randomized controlled Clinical trial Evaluating the effect of administration of Lactocare® probiotic on gasterointestinal symptoms and Anti-Ttg antibody in patients with celiac disease: Randomized controlled Clinical trial 2023-01-20 anticipated 98 Complete https://irct.ir/trial/67629 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: In order to randomize the samples, we use the block method with blocks of four. In this way, one of the following blocks is chosen randomly (for example, with a dice) and according to the order of those samples, We assign two groups. And the fourth sample will be assigned to the group receiving the supplements. Then, for the next four samples, we will randomly select a block and make the allocation according to it, and this process will continue until the end of the sampling. If a woman 35-year-old with a body mass index of 29 is in the target group, there will be another patient with similar characteristics in the control group, and the cut-off for these values has not been defined, and it will be tried to compare the patients of the two groups with a reasonable standard deviation in These variables are similar, Blinding description: The study is double-blind, so that all patients and doctors evaluating the interventions designed in the study or the outcomes after carrying out the plan will not know about the group in which the patient is examined. All interventions in both groups will be designed similarly and the procedure will be the same on all samples in all groups. The drugs used will also be supplied in the same form and packaging so that it is not possible to identify the study group during the study process. 3 celiac disease. Intervention 1: Intervention group: Including 49 patients, they will use 2 capsules of Lactocar probiotic every day for 6 weeks, with an interval of 12 hours, and along with this medicine, they will follow a gluten-free diet. Intervention 2: Control group: Including 49 patients, they will use 2 capsules of placebo every day for 6 weeks, with an interval of 12 hours, and along with this medicine, they will follow a gluten-free diet. Yes - There is a plan to make this available What will be shared: All deidentified data will be available in case of any requests from other researchers. When: Data availability will be started after publishing the full paper until 6 months later. To whom: Data will be available for all academic and also pharmaceutical researchers requires. Conditions: Data will available for those with a clear history of research. Where to obtain: Data will be available by direct request from the PI (Dr.Amiriani) by E-mail. How to obtain: It will be available after about one months. Comments:
public Taghi Amiriani
Third floor, Abbassi Heart complex, Golestan Research Center of Gastroenterology and Hepatology, Sayyad Hospital, Gorgan city
Gorgan Iran (Islamic Republic of) 4917867439 +98 17 3225 1910 ext. 2637 s_besharat_gp@yahoo.com Gorgan University of Medical Sciences scientific Taghi Amiriani
Third floor, Abbassi Heart complex, Golestan Research Center of Gastroenterology and Hepatology, Sayyad Hospital, Gorgan city
Gorgan Iran (Islamic Republic of) 4917867439 +98 17 3225 1910 ext. 2637 s_besharat_gp@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Confirmation of celiac disease with small intestine biopsy Measurement of antibody titer against tissue transglutaminase (Anti TTg) Age above 18 years 18 years no limit Both Any recent infections Concomitant inflammatory bowel disease (IBD) Immune deficiency (acquired or non-acquired) Taking drugs that affect the immune system (immune suppressors and stimulants) Recent GI surgery Taking NSAID painkillers or antibiotics in the last 6 weeks Having cancer or being HIV positive Cardiovascular diseases, glands, kidney, liver, neurological or mental malignancy Pregnancy and breastfeeding Alcohol and drug addiction Participation in another similar study within the last 6 months unwillingness to take probiotics patient being out of reach K90.0 Celiac disease Treatment - Drugs Placebo Intervention group: Including 49 patients, they will use 2 capsules of Lactocar probiotic every day for 6 weeks, with an interval of 12 hours, and along with this medicine, they will follow a gluten-free diet. Control group: Including 49 patients, they will use 2 capsules of placebo every day for 6 weeks, with an interval of 12 hours, and along with this medicine, they will follow a gluten-free diet. The severity and extent of disease symptoms. Timepoint: The beginning of the study and 6 weeks after the start of the study. Method of measurement: CSI ( celiac symptom index ) questionnaire. Tissue transglutaminase antibody titer (Anti-Ttg). Timepoint: The beginning of the study and 6 weeks after the start of the study. Method of measurement: titer Anti-TTG. Zist Takhmir pharmaceutical company Approved 2022-12-25 Ethical committee of Golestan University of Medical Sciences Golestan University of Medical Sciences-Hircan Boulevard-Gorgan city-Golestan province- Gorgan Golestan Iran (Islamic Republic of)