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Can a soy diet soothe Crohn's? new study investigates gut bacteria changes

NCT ID NCT04065048

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a soy-based diet or a similar diet without soy changes gut bacteria in people with Crohn's disease (in remission or active) and healthy volunteers. Researchers measured inflammation markers and tracked whether symptoms stayed stable over one week. The goal was to understand how diet might influence the gut microbiome and inflammation in Crohn's disease.

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

67 people

The number who actually took part.

Started

Nov 2019

Finished

Oct 2023

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

18 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: * CD subjects: Documented diagnosis of Crohn's disease. Control subjects: no documented diagnosis of CD. * CD subjects: Harvey Bradshaw Index (HBI) score \<4 ('CD remission'), or with HBI score \>8 ('CD moderate disease') * Capable of providing consent to participate * Access to technology that permits the daily completion of study related activities * Able to receive and have an adult sign for food shipments delivered to a work or home environment. * Negative pregnancy test at screening visit in females of childbearing potential * Able to take oral nutrition and medication intake for 3 months prior to and at time of study enrolment. * 'CD remission' subjects: No change in 'IBD related' medications within 8 weeks prior to normally scheduled appointment with treating gastroenterologist (pre-screening): biologics, immunosuppressants, corticosteroids. Exclusion Criteria: * Short bowel syndrome. * Hospitalized patients * Body mass Index \<19 kg/m or ≥35. * Known clinically significant liver/gallbladder/pancreatic disease/dysfunction * Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients. * Uncontrolled Diabetes Type I type II * Known drug abuse. * Known parasitic disease of the digestive system. symptomatic intestinal stricture. * Presence of an ostomy. * Known concurrent malignancy. * Other conditions that would be a contraindication to and of the study diets (e.g. Soy, peanut, wheat, gluten allergy.) or preclude the participant from completing the study * Start of new 'IBD related' medications within 8 weeks prior to enrollment: biologics, immunosuppressants, corticosteroids. * Documented C difficile colitis within four weeks of screening * Well-founded doubt about the patient's cooperation. * Existing pregnancy or lactation. * Current participation in another diet intervention, simultaneous participation in another clinical trial, or participation in any other dietary intervention trial within the last 30 days. * History of \<3 natural bowel movements per week. * Unable to access to technology that permits the daily completion of study related activities. * Currently consuming a soy-based diet

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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.

Contacts and locations

Locations

  • University Hospitals Digestive Health Institute

    Cleveland, Ohio, 44106, United States

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