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IRCT20241209063999N1 IRCT 2025-03-15 Tehran University of Medical Sciences Investigating the Effects of Synbiotic Supplements on Micronutrients after Sleeve Gastrectomy Surgery Investigating the Effectiveness of Synbiotic Supplements on Micronutrient Status after Sleeve Gastrectomy Surgery 2025-01-20 anticipated 76 Complete https://irct.ir/trial/80659 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are placed in blocks of 4 or 6 and assigned to either the intervention or control group using a computer-generated random sequence. The allocation of patients to each block is based on the following criteria: Gender (male/female) Age (under 40 years and over 40 years) Underlying conditions (diabetes), Blinding description: Participants in each block are randomly divided into two groups, and each is assigned a unique code. Only the individual responsible for distributing the drug/placebo has access to the codes identifying patients in the intervention/control groups. The drug and placebo are prepared in identical packages and consumed in the same manner. The clinical team, which has direct contact with the patients and evaluates the study outcomes, will not have access to the group assignment list. Researchers will not have access to the group codes until data collection is complete. 3 Obesity. Intervention 1: Intervention group: The synbiotic supplement BioGen®, manufactured by Tak Gene Zist, contains strains of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus plantarum, Streptococcus thermophilus, and Bifidobacterium longum (total 10⁹ CFU per sachet) along with 4 grams of inulin (IRC code 2922037751120054). It is administered every 12 hours for a duration of 3 months. Intervention 2: Control group: The placebo, identical in appearance and taste to the synbiotic supplement (contains starch in the same volume as the supplement). Yes - There is a plan to make this available What will be shared: Demographic information and study outcomes, including plasma micronutrients and glucose and lipid profiles of the patients, will be published in an anonymized form. When: 6 months after publication of the article. To whom: Anonymized data will be available to researchers for scientific research purposes. Conditions: Anonymized data, with source citation, can be used for future study designs, meta-analysis, and review articles. Where to obtain: Applicants can obtain this information by contacting via the following email or fax: Email: mm-abbasi@student.tums.ac.ir Fax: +982188633039 Mohammadmahdi Abbasi - Principal Investigator How to obtain: After correspondence, the request will be approved by the Research Council of the Obesity and Eating Habits Research Center, and the results will be communicated to the applicant via fax or email within 10-14 days. Comments:
public Mohammadmahdi Abbasi
Dr. Shariati Educational, Research, and Treatment Center, North Kargar St., Jalal Al-Ahmad Intersection, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 mm-abbasi@student.tums.ac.ir Tehran University of Medical Sciences scientific Mohammadmahdi Abbasi
Dr. Shariati Educational, Research, and Treatment Center, North Kargar St., Jalal Al-Ahmad Intersection, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 mm-abbasi@student.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adults (18 to 65 years old) who, according to NIH guidelines, have class 3 obesity or class 2 obesity with at least one obesity-related co-morbidity and have undergone SG surgery within the past month Willingness to adhere to supplement intake and follow-up programs 18 years 65 years Both Pregnant or lactating women Patients consuming other probiotic/prebiotic supplements, taking antibiotics up to 10 days before the start of the intervention, or using medications that affect gut microbiota The presence of severe malabsorption syndromes unrelated to surgery (inflammatory bowel disease, celiac disease, etc.) Presence of previous nutritional deficiencies Presence of any gastrointestinal diseases Presence of surgical complications (such as fistula at the incision site, gastrointestinal bleeding, intestinal obstruction, etc.) Unable to comprehend the purpose of evaluations or the proposed treatment Patients who refuse to participate in the study until its completion E66 Overweight and obesity Treatment - Drugs Treatment - Drugs Intervention group: The synbiotic supplement BioGen®, manufactured by Tak Gene Zist, contains strains of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus plantarum, Streptococcus thermophilus, and Bifidobacterium longum (total 10⁹ CFU per sachet) along with 4 grams of inulin (IRC code 2922037751120054). It is administered every 12 hours for a duration of 3 months. Control group: The placebo, identical in appearance and taste to the synbiotic supplement (contains starch in the same volume as the supplement). Serum 25-hydroxy vitamin D. Timepoint: Before the start of the intervention, and 3 and 6 months after the intervention begins. Method of measurement: immunoassay. Serum vitamin B12. Timepoint: Before the start of the intervention, and 3 and 6 months after the intervention begins. Method of measurement: Electrochemiluminescence. Serum Iron. Timepoint: Before the start of the intervention, and 3 and 6 months after the intervention begins. Method of measurement: spectrophotometry. TIBC (Total Iron-Binding Capacity). Timepoint: Before the start of the intervention, and 3 and 6 months after the intervention begins. Method of measurement: spectrophotometry. Serum Ferritin. Timepoint: Before the start of the intervention, and 3 and 6 months after the intervention begins. Method of measurement: immunoassay. Serum Folate. Timepoint: Before the start of the intervention, and 3 and 6 months after the intervention begins. Method of measurement: Radioimmunoassay. Serum total Calcium. Timepoint: Before the start of the intervention, and 3 and 6 months after the intervention begins. Method of measurement: colorimetry. Tehran University of Medical Sciences Approved 2025-03-10 Ethics committee of Tehran University of Medical Sciences Dr. Shariati Educational, Research, and Treatment Center, North Kargar St., Jalal Al-Ahmad Intersection, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)