Status:

RECRUITING

Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance

Lead Sponsor:

Oregon Health and Science University

Collaborating Sponsors:

University of Oregon

Oregon State University

Conditions:

Carbohydrate Intolerance

Eligibility:

All Genders

5-18 years

Phase:

NA

Brief Summary

In this project we want to assess impact of dietary fructose as a simple sugar intolerance on abdominal pain and compare a low FODMAP diet versus an added sugar elimination diet effectiveness on sympt...

Detailed Description

This is a prospective cross over study. Participants who meet the study entry criterion, will be randomized to a specific dietary intervention: low FODMAP for a 3-week period or Limited Added Sugar fo...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 26 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06057376

Start Date

October 26 2023

End Date

February 1 2026

Last Update

April 2 2024

Active Locations (1)

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Oregon Health and Science University

Springfield, Oregon, United States, 97477