RECRUITING

Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 symptoms but also impact on microbiome and its metabolome.

Official Title

Clinical Comparison of the Impact of Two Dietary Interventions on Abdominal Pain and Intestinal Microbiome Caused by Simple Carbohydrate Intolerance.

Quick Facts

Study Start:2023-10-26

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06057376

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Anna Hunter, MD

CONTACT

(503) 494-1098

huntean@ohsu.edu

Deepannita Roy, MPH

CONTACT

503-494-8344

royde@ohsu.edu

Principal Investigator

Anna Hunter, MD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health and Science University

Springfield, Oregon, 97477

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Anna Hunter, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-26

Study Completion Date2026-02

Study Record Updates

Study Start Date2023-10-26

Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

Carbohydrate Intolerance