Can a soy diet soothe Crohn's? new study investigates gut bacteria changes
NCT ID NCT04065048
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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67 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Oct 2023
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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University Hospitals Digestive Health Institute
Cleveland, Ohio, 44106, United States
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Other studies related to the condition(s) this trial covers.
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