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Could a special liquid diet soothe IBD in rare immune disease?

NCT ID NCT03983837

Symptom relief Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a liquid diet called Neocate Splash could change gut bacteria and ease stomach symptoms in people with chronic granulomatous disease (CGD) and inflammatory bowel disease (IBD). Three participants followed the diet for up to 4 weeks, with hospital stays and follow-up visits. Researchers measured changes in gut bacteria and tracked side effects and symptom relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Neocate Splash (an amino acid-based liquid diet)
What this could lead to
If it works, this could point toward a dietary approach to manage IBD symptoms in people with CGD.
What could go wrong
This is a very small, early-phase study with only 3 participants, so results may not apply to others. The diet is restrictive and may be hard to tolerate.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

3 people

The number who actually took part.

Started

Jun 2021

Finished

Nov 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

8 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: Individuals must meet all of the following criteria to be eligible for study participation: * Aged 8-65 years. * Have confirmed diagnoses of CGD, CGD-associated colitis, and IBD. * Have a Simple Endoscopic Score for Crohn Disease (SES-CD) \> 3 and/or HBI \>= 5. * Able to provide informed consent. * Willing to allow storage of biological samples for future research. * Willing to allow genetic testing on biological samples. * Willing to be admitted as inpatient for up to 2 weeks to initiate the elemental diet. EXCLUSION CRITERIA: * Pregnancy. * Active or ongoing infection that requires antibiotics other than the participant s known prophylaxis medications. * Any condition that, in the opinion of the investigator, contraindicates participation in this study will be excluded from study participation.

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Conditions

The condition(s) this trial relates to.

chronic granulomatous disease Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Chronic granulomatous disease Inflammatory bowel disease

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.