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

Determining the effect of synbiotic supplementation on gastrointestinal symptoms and quality of life in patients with celiac disease

This study is a parallel randomized double-blind clinical trial, phase 3 on 108 patients who are divided into intervention and control groups. The "random block" method will be used for randomization. We generate blocks with Random Allocation Software.

This study was performed on 108 people with celiac disease referred to the celiac clinic of Bustan clinic in Kermanshah. Patients will be divided into two groups based on random allocation. The first group of patients who will receive synbiotic product in the amount of 2 capsules per day and the second group who will receive placebo as a control group. Evaluations are performed in two stages at the beginning and end of the study (12 weeks later). For blinding, placebo and synbiotic supplements are placed in the same color capsules and drug packages and will receive a special code from the manufacturer. The codes will remain with the manufacturer until the end of the study to blind researchers and patients.

Inclusion criteria: Willingness to cooperate Definitive diagnosis of celiac disease Age over 18 years and less than 65 years Do not take any dietary supplements Do not suffer from chronic diseases Exclusion criteria: Allergic reaction to the supplement Consume less than 80% of the drug Changes in the type of daily medication such as Antacids, Antibiotics, PPI, H2 blocher Failure to follow a gluten-free diet Pregnancy and lactation

Patients with celiac disease

Gastrointestinal symptoms, Quality of Life

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.

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.