Phase II Study of Soluble Fiber Supplement to Improve Asthma in Children Ages 6 to 17

What this Trial Is About

This Phase II randomized controlled clinical trial examines the impact of increasing soluble fiber intake with Fruitafit Inulin on the gut microbiome and asthma in children. Participants will complete an ASA 24 dietary recall questionnaire to assess fiber intake and, if eligible, will be assigned to either Fruitafit Inulin or placebo Maltodextrin to reach their target fiber dosage. Participants will complete an Asthma Control Questionnaire, provide blood serum, nasal wash, and fecal samples, and receive counseling from a pharmacist on how to include the study medication in their diet. Three stool sample kits will be collected for microbiome and metabolomic analysis, with samples sent during the study and after the final visit. Study procedures, including the ASA 24 questionnaire, will be repeated at the second visit. The total study time is approximately 30 days. Risks include fecal contamination, discomfort from specimen collection, discomfort with answering some survey questions, and risks associated with blood draws. Participants are compensated for their time and receive a portion of their dietary results. There may be no direct benefit to participants, but the research may help improve understanding of how fiber, diet, the gut microbiome, and asthma are connected and whether asthma may be improved by altering diet.

A Clinical Trial of Soluble Fiber for Asthma