Comparing two diets for managing carbohydrate intolerance in children and teens
Clinical Comparison of the Impact of Two Dietary Interventions on Abdominal Pain and Intestinal Microbiome Caused by Simple Carbohydrate Intolerance.
This study is testing whether a low FODMAP diet or a limited added sugar diet can help children and teens with carbohydrate intolerance feel better and reduce their stomach pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Springfield, Oregon) |
| Trial ID | NCT06057376 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of two dietary interventions, a low FODMAP diet and a limited added sugar diet, on abdominal pain in children and adolescents with carbohydrate intolerance. Participants aged 5 to 18 will be randomized to one of the two diets for three weeks, followed by a crossover to the other diet after a break. The study includes nutrition counseling sessions and collects stool samples to analyze changes in the microbiome and symptom data through online surveys. The goal is to determine which dietary approach is more effective in alleviating symptoms and improving gut health.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 5 to 18 with a positive fructose breath test and normal BMI.
Not a fit: Patients with known intestinal disorders, negative fructose breath tests, or significant food restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective dietary strategies for managing carbohydrate intolerance in children and adolescents.
How similar studies have performed: Previous studies have shown promising results with dietary interventions for managing carbohydrate intolerance, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 5- 18-year-old * BMI: within normal range for age * Positive fructose breath test performed as part of diagnostic work up for abdominal pain * Willingness to consume low FODMAP and Limited Added sugar diet trial and collect required samples Exclusion Criteria: * Age: not within range * BMI: not within range * Negative fructose breath test * Any known or suspected intestinal disorder including but not limited to IBD, IBS, celiac disease, Crohn's Disease, food sensitivities, food allergies, significant by-choice food restrictions * Hormonal disorders * Use of chronic medications including contraceptives (both oral and subcutaneous), non-hormone secreting IUD- accepted * Use of oral or IV antibiotics in the last three months * Daily probiotic use (pill form) * Daily multi-vitamin except vitamin D supplements
Where this trial is running
Springfield, Oregon
- Oregon Health and Science University — Springfield, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Anna Hunter, MD — Oregon Health and Science University
- Study coordinator: Anna Hunter, MD
- Email: huntean@ohsu.edu
- Phone: (503) 494-1098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.