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Could a traditional puerto rican diet tame Crohn's Flare-Ups?

NCT ID NCT05627128

Disease control Sponsor: University of Massachusetts, Worcester Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special anti-inflammatory diet, adapted to include traditional Puerto Rican foods, can help people with Crohn's disease feel better and reduce gut inflammation. About 150 adults with mild to moderate Crohn's will follow either the diet or their usual eating habits for several weeks. The goal is to see if the diet improves quality of life and lowers markers of inflammation in the blood and stool.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 21 to 65 years old * Confirmed CD diagnosis with sCDAI \<450 (includes values ranging from remission, mild to moderate activity) * Moderate to severe impaired QoL (sIBDQ\<60) * Stable doses of medications are screened; thiopurines, natalizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab, vedolizumab (8 weeks), 5-aminosalicylic acid (5-ASA) (2 weeks), steroids (1 week) * Willingness and capacity to significantly change diet (arm 1) * Willing and able to comply with specimen collection and other study procedures, and to complete the study Exclusion Criteria: * Ostomy * Use of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screening * Use of prescribed probiotics within 4 weeks of screening * \> 20mg prednisone or equivalent * Recent C. difficile colitis * Pregnancy * Presence of symptomatic or significant structure or history of obstruction in the past 6 months

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Conditions

The condition(s) this trial relates to.

Crohn disease Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease

Contacts and locations

Locations

  • University of Massachusetts Chan MedicaL School

    Worcester, Massachusetts, 01605, United States

  • University of Puerto Rico

    San Juan, Puerto Rico, 00935, Puerto Rico

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