Clinical Research Directory

Study on Changes in Gut Microbiota, Inflammatory Factors, and Bowel Habits Following Oral Administration of Recombinant B-subunit/Whole Cell Cholera Vaccine in a Community Population

This randomized, placebo-controlled clinical trial aims to investigate the effects of oral cholera vaccine administration on three aspects of gut health in healthy adult community members aged 18 years and older: (1) the composition and function of gut microbiota, (2) serum inflammatory cytokine levels, and (3) bowel habits. The study is designed as an exploratory/basic science investigation to generate hypotheses about how cholera vaccination may influence intestinal health in healthy populations. The findings from this study may provide valuable insights into vaccine-induced changes in the gut microbiome and immune responses, which could inform future research on oral vaccines and their extra-intestinal effects. Participants who agree to take part in this study will be asked to complete the following procedures at two time points: before receiving the study intervention (baseline) and 28 days after completing the full vaccine series. Approximately 200 healthy adults aged 18 years and older from the community will be enrolled in this study. Participants will be randomly assigned in a 1:1 ratio to one of two study groups: Intervention Group (Vaccine Group): receive the oral cholera vaccine according to the manufacturer's recommended schedule; Control Group (Placebo Group): receive a placebo that looks identical to the vaccine but contains no active ingredient. The study will measure the following outcomes to evaluate the effects of cholera vaccine:Gut Microbiota Changes, Serum Inflammatory Cytokine Levels and Bowel Habit Changes.

Test Anxiety on Bowel Health and Constipation in Students

This observational cross-sectional study aims to examine the relationship between test anxiety, bowel health, and constipation in university students. The study will include undergraduate students aged 18 years and older who are studying in the Physiotherapy and Rehabilitation Department at Lokman Hekim University and who are in their final examination period. Participants will complete self-report questionnaires during a single face-to-face assessment session. Constipation status will be evaluated using the Rome IV criteria, stool form will be assessed using the Bristol Stool Scale, constipation severity will be assessed using the Constipation Severity Instrument, and test anxiety level will be assessed using the Test Anxiety Inventory. Sociodemographic characteristics and bowel-related symptoms will also be recorded. The study does not include any intervention or treatment. The findings are expected to help better understand whether test anxiety during examination periods is associated with bowel health problems and constipation in university students.