Clinical Research Directory

Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders

This randomized, double-blind, placebo-controlled trial will evaluate the effects of a 14-day course of rifaximin on bloating symptoms, gut microbiota, microbial metabolites, and intestinal gases in adults with Rome V irritable bowel syndrome with constipation (IBS-C) or functional abdominal bloating (FAB). Participants with predominant, bothersome bloating despite adequate bowel movement management will be randomly assigned in a 1:1 ratio to receive rifaximin 550 mg three times daily or matching placebo for 2 weeks. The primary endpoint is the proportion of participants with a bloating response, defined as at least a 1-point reduction from baseline on a 7-point Likert bloating scale at the end of treatment. Additional assessments will include other gastrointestinal symptoms, quality of life, psychological symptoms, gut microbiota diversity and composition, fecal short-chain fatty acids, plasma bile acids and gut-derived uremic toxins, and breath hydrogen and methane levels. Associations between biological changes and clinical response will also be examined.

Breastmilk and the Link to Overweight/Obesity and Maternal Diet in the Mother-breastmilk-child Triad

The prospective 5-month follow-up study will involve 150 mother-infant dyads grouped based on maternal baseline BMI category (normal weight, overweight, obesity). The investigators plan 3 study visits (1, 3, and 6 months postpartum) with analysis the following parameters and outcomes: 1. maternal anthropometry and body composition; 2. maternal dietary intake and dietary patterns (with results of biomarker-based validation); 3. maternal status of lipophilic antioxidants, selected vitamins, and fatty acids profile that may be related to adipose tissue metabolism, inflammation, and cardiometabolic status; 4. maternal metabolomics, adipokines, insulin, selected biomarkers of inflammation, altered glucose metabolism, and oxidation; 5. breastmilk composition assessed by systemic approach (macronutrients, fatty acids profile, lipophilic antioxidants, adipokines, hormones, immunological profile, and preliminary lipidomic analysis in part of the study group); 6. infant growth trajectory, body composition, urine metabolomics, and biomarkers of oxidative stress. Additionally, maternal and infant stool, buccal swabs, and human milk samples will be banked for further microbiome analysis studies.