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RecruitingPhase 2

A Clinical Trial of Soluble Fiber for Asthma

A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake."
  • "Each participant will fil out an Asthma Control Questionnaire (ACQ), collect a nasal wash, and have their blood drawn."
  • "All the procedures will be repeated again including taking the ASA 24 questionnaire."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether soluble fiber (Fruitafit Inulin) may help improve asthma in children ages 6–17. Children will get either fiber or a placebo, a drink without the study fiber. Researchers will study how diet and fiber affect gut microbes, tiny living things in the gut, and how these may be linked to asthma.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are ages 6–17.
  • Were diagnosed with asthma within the last 2 years.
  • Have a breath nitric oxide (FeNO) level above 50 ppb, a sign of swelling in the airways, OR a history of environmental allergies shown by a positive skin prick or specific IgE blood test for airborne allergens.
  • Have not visited an emergency department in the past month.
  • Can drink the fiber or placebo drink.
  • Can return for a follow-up visit in 4–6 weeks.
  • Do not follow a special or unique diet.

Who can't join

  • Have cystic fibrosis, a disease that causes thick, sticky mucus.
  • Have bronchiectasis, a condition where damaged airways become wider.
  • Plan to change asthma medicines in the next 4–6 weeks, other than quick-relief medicines that open the airways.
  • Eat 16 grams of fiber or less per day, based on the ASA 24 food questionnaire before the study.
  • Have a brother or sister already in the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Between ages 6-17 * Asthma diagnosis within the last 2 years * Fractional excretion of exhaled nitric oxide (FeNO) \> 50 ppb OR a clinical history of environmental allergies as defined by a positive skin prick or positive specific immunoglobulin E (IgE) tests to aeroallergens * No emergency department visits in the past 1 month * Ability to consume a liquid drink of fiber or placebo * Ability to return for a 4-6 week follow-up visit * No special or unique diet Exclusion Criteria: * Cystic fibrosis * Bronchiectasis * Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks * Baseline estimated daily fiber intake less than or equal to 16 grams as determined by the ASA 24 * Sibling of a participant already enrolled in the study

Study sites (1)

AZ