Recruiting

Dietary Interventions

Sponsor:

Oregon Health and Science University

Code:

NCT06057376

Conditions

Carbohydrate Intolerance

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Low-FODMAP diet group (LFD)

Low Sugar diet group (LAS)

Study Details

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 symptoms but also impact on microbiome and its metabolome.

Conditions

Carbohydrate Intolerance

Study ID

NCT06057376

Start date

Oct 26, 2023

Status verified date

Apr, 2024

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Low FODMAP group

Participants randomized to this group will be instructed based on published low-FODMAP diet guidelines and provided with sample meal plans to aid in compliance. Each participant will be randomized to low-FODMAP diet group (LFD) for 3 weeks.

other: Low Added Sugar group

Each participant will be randomized to either the low-FODMAP diet group (LFD) or the low added sugar diet group (LAS) for 3 weeks. Each participant will be randomized to the low added sugar diet group (LAS) for 3 weeks.

Interventions

Low-FODMAP diet group (LFD)

Each participant will be following a low-FODMAP diet group for 3 weeks, followed by 3 week break prior to second diet intervention.

Low Sugar diet group (LAS)

Each participant will be following a low added sugar diet group for 3 weeks, after 3 week break.

Primary outcome measure

  • Abdominal Pain [ Time Frame: 63 days ]
  • Effect of each diet on microbiome and metabolome [ Time Frame: 63 days ]

Central Contacts and Locations

Central contacts

Anna Hunter, MD

(503) 494-1098huntean@ohsu.edu

Deepannita Roy, MPH

503-494-8344royde@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Springfield, Oregon, United States, 97477

Contacts

Anna Hunter, MD

503-494-1098huntean@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 2, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-04-02.