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IRCT20210717051916N1 IRCT 2022-04-23 Kermanshah University of Medical Sciences A study of the effect of Synbiotic Supplement in Gastrointestinal Symptoms and Quality of Life in Patient with Celiac Disease: a randomized double blinded clinical trial A study of the effect of Synbiotic Supplement in Gastrointestinal Symptoms and Quality of Life in Patient with Celiac Disease: a randomized double blinded clinical trial 2022-05-22 anticipated 108 Complete https://irct.ir/trial/57829 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized parallel double-blind clinical trial. Randomization will be done using block randomization. We produce 27 blocks (each block contains 4 codes ) by Random Allocation Software. All 4 people correspond to one block, respectively. The blocks are produced by a statistician and it will be made available to the nutritionist who assigns the individuals. The hiding mechanism is such that the statistical consultant generates a random sequence, the student registers individuals and a nutritional partner assigns individuals to intervention groups. The codes of the assigned individuals are only with the nutritionist who does not participate in the measurements, Blinding description: The student registers people. The blocks are produced by a statistician and will be provided to a nutritionist who assigns individuals. The nutritionist is not involved in the measurements. The statistician who determines the blocks will also be blinded to avoid bias in the analysis. For blinding, placebo and synbiotic supplements are placed in the same color capsules and drug packages. Drug packages in the manufacturer will have a special code. The codes will remain with the manufacturer until the end of the study to blind researchers and patients. 3 Patients with celiac disease. Intervention group: To individuals in the intervention group, Familact synbiotic capsules are given from Zist Takhmir pharmaceutical company. each capsule of which contains 500 mg of synbiotic product. People take 2 capsules daily for 12 weeks. Each synbiotic capsule contains beneficial bacterial strains by counting 109 CFU ( Colony-forming unit ) and prebiotics as follows: Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus, Fructooligosaccharides (FOS). In the fasting state, all participants will have anthropometric assessments, including height, weight, body mass index, hip circumference, and waist circumference. In order to be aware of the patient's compliance with the supplement and possible side effects of the supplement, patients are contacted on a weekly basis. The rate of supplementation by patients is assessed through telephone calls as well as through the return of packages containing capsules. Consumption of less than 80% of synbiotic capsules at the end of 12 weeks is considered as low adherence. At the end of the supplementary support period (12 weeks), the assessments (except for patients' height) will be performed again. In these patients, quality of life, severity of gastrointestinal symptoms and adherence to gluten-free diet will be assessed by relevant questionnaires at the beginning and end of the intervention.. 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 There is no more information.
public Mehdi Zobeiri
Parastar Blvd., Imam Reza Hospital
kermanshah Iran (Islamic Republic of) 75333 - 67427 +98 83 3427 6300 mehdizobeiri@yahoo.com Kermanshah University of Medical Sciences scientific Mehdi Zobeiri
Parastar Blvd., Imam Reza Hospital
kermanshah Iran (Islamic Republic of) 75333 - 67427 +98 83 3427 6300 mehdizobeiri@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of celiac disease based on test results and specialist diagnosis 18 years 65 years Both pregnancy- Breastfeeding K90.0 Celiac disease Treatment - Drugs Intervention group: To individuals in the intervention group, Familact synbiotic capsules are given from Zist Takhmir pharmaceutical company. each capsule of which contains 500 mg of synbiotic product. People take 2 capsules daily for 12 weeks. Each synbiotic capsule contains beneficial bacterial strains by counting 109 CFU ( Colony-forming unit ) and prebiotics as follows: Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus, Fructooligosaccharides (FOS). In the fasting state, all participants will have anthropometric assessments, including height, weight, body mass index, hip circumference, and waist circumference. In order to be aware of the patient's compliance with the supplement and possible side effects of the supplement, patients are contacted on a weekly basis. The rate of supplementation by patients is assessed through telephone calls as well as through the return of packages containing capsules. Consumption of less than 80% of synbiotic capsules at the end of 12 weeks is considered as low adherence. At the end of the supplementary support period (12 weeks), the assessments (except for patients' height) will be performed again. In these patients, quality of life, severity of gastrointestinal symptoms and adherence to gluten-free diet will be assessed by relevant questionnaires at the beginning and end of the intervention. Gastrointestinal symptoms of patients before and after taking the supplement. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later. Method of measurement: Gastrointestinal Symptom Rating Scale questionnaire (GSRS). Quality of life of patients. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later. Method of measurement: The celiac disease quality of life questionnaire (CDQOL). Kermanshah University of Medical Sciences Approved 2022-01-09 Ethics committee of Kermanshah University of Medical Sciences Parastar Blvd., Imam Reza Hospital Kermanshah Kermanshah Iran (Islamic Republic of)