COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a randomised open label study, comparing the FIT diet with standard diet in patients with Crohn's disease treated with biologic therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease

NCT04842149

Crohn Disease

COMPLETED NA

A Study of Abatacept in Patients With Active Crohn's Disease

NCT00406653

Crohn's Disease

TERMINATED PHASE3

A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

NCT02782663

Crohn's Disease (CD)

COMPLETED PHASE2

Whole-Food, Plant-Based Diet for Active Crohn's Disease

NCT04982666

Crohn Disease

WITHDRAWN NA

Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease

NCT01442025

Crohn's Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease Inflammatory Bowel Diseases Diet, Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FIT group

Patients treated with biological treatment and the FIT diet

Group Type EXPERIMENTAL

FIT diet

Intervention Type OTHER

Dietary intervention as add-on therapy to biologicals

Control group

Patients treated with biological treatment and the standard diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FIT diet

Dietary intervention as add-on therapy to biologicals

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients (18-80 years)
* active inflammation of terminal ileum and/or colon with a Simple Endoscopic Score for Crohn's Disease (SES-CD) greater than 5 (or greater than 3 for patients with isolated ileitis),
* patient reported outcome 2 (PRO2 - 7 day average daily stool frequency x 2 + 7 day average daily abdominal pain score x 5) \> 8,
* faecal calprotectin above 250 µg/g.

Exclusion Criteria

* Abcess,
* Bowel resection within 6 months before enrolment,
* Ostomy,
* Short-bowel syndrome,
* Clinically significant stricture that could require surgery,
* Pregnant,
* Lactating woman or desire to become pregnant during the study,
* Unwilling or unable to follow the study diet.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No