Could Fiber-Rich foods help children with short bowel syndrome?

NCT ID NCT05432648

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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

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Status unknown
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First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study investigates how well children with short bowel syndrome tolerate dietary fiber from green bean puree compared to children without the condition. Researchers will track digestive symptoms and changes in gut bacteria to understand if fiber can be safely introduced into their diets. The goal is to improve nutrition and reduce reliance on IV feeding.

What this could mean

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

Active substance
green bean puree
What this could lead to
If well tolerated, fiber foods could be safely added to the diets of children with short bowel syndrome, potentially improving gut health and reducing dependence on IV nutrition.
What could go wrong
This is a small, early-stage study. Fiber may cause digestive symptoms in some children, and results may not apply to all patients with short bowel syndrome.

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 60 people

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

Started

May 2022

Expected to finish

Oct 2027

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

4 months to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Actively follows at the Children's Hospital of Philadelphia (CHOP) outpatient clinics * SBS arm specific: History of SBS diagnosis. History of short bowel syndrome based on surgical/imaging records. Small bowel is in continuity with some portion of colon * Control arm specific: No history of intestinal pathologies * No or negligible amount (few bites of fiber-containing foods okay) of fiber in tube feeds or by mouth at baseline * Less than 20% calories from oral food not containing fiber while the other 80% may be by enteral and/or parenteral feedings * At least 20% calories from fiber-free formula taken orally or via tube * Antibiotic use is allowed, however, should be on a stable regimen of antibiotics starting from 2 weeks prior to intervention until end of study or end of week 3 whichever is sooner. Instances of antibiotic use for brief courses (7-10 days) as long as sample collection is scheduled to be at least a week from the end date of antibiotics. * Previous history of fiber introduction failure is acceptable as long as clinically stable at the time of recruitment * Fiber supplementation is appropriate per primary physician * If subject is unable to provide full set of samples, they will still be enrolled Exclusion Criteria: * SBS Arm specific: No diagnosis of SBS. * Control Arm specific: has baseline intestinal diseases * Small bowel and colon not in continuity (Ex: presence of ileostomy or jejunostomy) * \>5% changes in percentage of calories from oral nutrition (PO), enteral nutrition (EN) and/or parenteral nutrition (PN) during the intervention * Addition/discontinuation/significant alteration to antibiotics regimen during study period * Primary physician does not think fiber supplementation is appropriate clinically

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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