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IRCT20200915048726N1 IRCT 2022-06-06 Mazandaran University of Medical Sciences Synbiotic effect on adult functional constipation Assessing the effect of probiotic on adult functional constipation 2022-07-23 anticipated 180 Complete https://irct.ir/trial/53980 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease the confounding effects, all participants will be randomly allocated into the control and intervention groups to receive psyllium, the standard treatment (n = 90), or psyllium and Gerilact supplement (n = 90) based on balanced block randomization (allocation 1: 1). Blocks with sizes 2, 4, and 6 are used. Excel software will be used to perform randomization. To conceal the randomization process, closed envelopes are used, which are opened at the patient's visit to minimize the gap between randomization and receiving medication or supplements. 3 functional constipation. Intervention 1: Control group: standard treatment (15 gr of psyllium daily) for 30 days. Intervention 2: Intervention group: standard treatment and GeriLact Capsules (zist takhmir, Tehran, Iran) twice daily (half an hour before breakfast and dinner) for 30 days. GeriLact will be continued alone for another 15 days. Yes - There is a plan to make this available What will be shared: All data can be shared when participants are not identifiable When: Ability to access data 6 months after publishing the results To whom: The data will be available to academic researchers and non-academic physicians Conditions: Perform other analyzes and extract more results Where to obtain: Please refer to the e-mail address of the corresponding author How to obtain: Submit a request to the Deputy of research and technology of the University / Refer the request to the relevant author of the project Comments:
public Arash Kazemi
Imam Khomeini Hospital., Razi Ave
Sari Iran (Islamic Republic of) 4816633131 +98 11 3337 4977 arash_6z@yahoo.com Mazandaran University of Medical Sciences scientific Arash Kazemi
Imam Khomeini Hospital., Razi Ave
Sari Iran (Islamic Republic of) 4816633131 +98 11 3337 4977 arash_6z@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with functional constipation according to Rome (III) criteria. Patients who do not change their diet during the study. Over 18 years 18 years no limit Both Depression systemic diseases such as diabetes, and inflammatory bowel disease Constipation due to hypothyroidism and hypercalcemia Surgeries such as prostate, bowel resection , and spine surgery Recent weight loss cancer Requiring colonoscopy Recent use of laxatives Pregnancy and lactation Alcohol and opium users Recent use of steroids, anticholinergics, antidepressants, iron, statins, cholestyramine, Cox-2 inhibitor, and sulfosalazine K59.00 Constipation, unspecified Treatment - Drugs Treatment - Drugs Control group: standard treatment (15 gr of psyllium daily) for 30 days Intervention group: standard treatment and GeriLact Capsules (zist takhmir, Tehran, Iran) twice daily (half an hour before breakfast and dinner) for 30 days. GeriLact will be continued alone for another 15 days Severity of constipation. Timepoint: At the beginning of the study (before the intervention), 15, 30, and 45 days after the beginning. Method of measurement: Wexner constipation Scoring System. Stool consistency. Timepoint: At the beginning of the study (before the intervention), 15, 30, and 45 days after the beginning. Method of measurement: Bristol scoring system. Side effects. Timepoint: At the beginning of the study (before the intervention), 15, 30, and 45 days after the beginning. Method of measurement: evaluation checklist. Remission. Timepoint: At the beginning of the study (before the intervention), 15, 30, and 45 days after the beginning. Method of measurement: Total scores obtained from Wexner and Bristol systems. Mazandaran University of Medical Sciences Approved 2020-09-23 Mazandaran University of Medical Sciences - Sari Imam educational and medical hospital Imam hospital, Razi Ave., Sari Town Sari Mazandaran Iran (Islamic Republic of)