Last updated: April 1, 2024
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lactose Intolerance
Gastrointestinal Diseases And Disorders
Treatment
Low Sugar diet group (LAS)
Low-FODMAP diet group (LFD)
Clinical Study ID
NCT06057376
IRB No.24928
Ages 5-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 abdominalpain
- Willingness to consume low FODMAP and Limited Added sugar diet trial and collectrequired samples
Exclusion
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, significantby-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
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Low Sugar diet group (LAS)
Phase:
Study Start date:
October 26, 2023
Estimated Completion Date:
February 28, 2026
Study Description
Connect with a study center
Oregon Health and Science University
Springfield, Oregon 97477
United StatesActive - Recruiting
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