A Phase 2 interventional study of Inulin in Asthma in Children, sponsored by Phoenix Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Phoenix Children's Hospital · Phase 2, Interventional, and Treatment
Randomized controlled trial of soluble fiber (Fruitafit Inulin). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (Fruitafit Inulin) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet.
A Phase II randomized, controlled, clinical trial analyzing the impact of increasing fiber intake and the gut microbiome for children with asthma. If eligible, (determined by inclusions/exclusion criteria as well as fiber intake assess by ASA 24) participants will be put into a fiber (Fruitafit Inulin) or placebo (Maltodextrin) group. Each participant will fil out an Asthma Control Questionnaire (ACQ), collect a nasal wash, and have their blood drawn. Their study medication will be available for them to pick up after their first visit, and they will receive counseling from the Pharmacist on how to implement it into their diet. They will also be sent home with three stool sample kits to be mailed to Northern Arizona University for microbiome and metabolomic analysis. The first kit will be sent within 7 days of their first visit. The second kit will be sent within 14 days (+/- 1 day) of their first visit. The second study visit will occur 25 days (+5 days) after the first visit. All the procedures will be repeated again including taking the ASA 24 questionnaire. The participant will send their final kit within 7 days of completing their last visit. Total study time is approx 30 days. This study is minimal risk which includes risk of fecal contamination, discomfort from collecting specimens, discomfort with answering some of the survey questions, and the risks associated with receiving a blood draw. Participants are compensated for their time and receive a portion of their dietary results. There may not be a direct benefit to the participant, but by participating in this research they may help people in the future with asthma.
Exclusion Criteria:
Participants are asked to complete a dietary recall questionnaire (ASA 24) that evaluates dietary intake in the last 24 hours. Participants are also sent home with a stool kit and instructions to collect a fecal sample for microbiome analysis. The purpose of the study is to better understand the pathways that connect diet and asthma.
Participants are asked to fill out a dietary recall questionnaire (ASA 24) to determine eligibility in the study. If eligible, a nasal wash and blood sample will be collected at the first visit. Study drug or placebo will be given to participant after their visit in a randomized double-blinded nature. The participant will also fil out an Asthma Control Questionnaire (ACQ) and be sent home with 3 stool kits for analysis. Participant will turn in one sample after first visit, the second in three weeks, and the last one after the second study visit. At this second study visit, procedures from the first study visit will be repeated.
Drug: Inulin
Soluble tapioca starch from Ingredion.
Also known as: Fruitafit CLR
Alpha diversity.
A total of 84 participants is required to find significant difference of 54 units of Richness at 90% power with a small effect size. Alpha diversity is used to measure the abundance that individual microbes can be observed. Statistical analysis is used to generate the significance of stool sample diversity as well as how many participants are needed to see the marker.
Time frame: 6 weeks
Asthma control.
Assessed via Asthma Control Questionnaire. Scores can range from 0 to 6. With a higher score indicating poor asthma control.
Time frame: 6 weeks
Gut microbiome composition.
Analysis of gut microbiome using quantitative polymerase chain reaction (qPCR) and analysis of variance (ANOVA).
Time frame: 6 weeks
Nasal inflammatory response.
Measured via quantitative polymerase chain reaction (qPCR).
Time frame: 6 weeks
Quantification of circulating short chain fatty acids.
Short chain fatty acids (SCFAs) will be collected and analyzed via microbiome and metabolomic analyses of stool samples and blood serum samples.
Time frame: 6 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Phoenix Children's Hospital