Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease (CDED)

July 8, 2026 updated by: Wei Wang, Sixth Affiliated Hospital, Sun Yat-sen University

Therapeutic Effect of Exclusion Diet Combined With Anti-TNF-α Biologics in Adult Patients With Crohn's Disease in China: A Single-center, Prospective, Randomized, Controlled Trial

Crohn's disease (CD) is a chronic inflammatory bowel disease with high recurrence and surgical rates. Mucosal healing is a key therapeutic goal, yet current anti-TNF-α biologics achieve only about 30% mucosal healing. Dietary intervention, particularly the Crohn's Disease Exclusion Diet (CDED), shows promise in CD management. Preliminary data suggest that combining CDED with anti-TNF-α biologics may significantly improve mucosal healing rates (42.9% vs 25%). This single-center, prospective, randomized, controlled trial will enroll 185 adult CD patients with active disease (SES-CD ≥3), randomly assigned 1:1 to receive either anti-TNF-α biologics plus CDED or anti-TNF-α biologics alone. The primary endpoint is mucosal healing rate at week 14 (SES-CD=0). Secondary endpoints include clinical remission, endoscopic response, transmural healing, and adverse events. This study aims to provide high-quality evidence for the efficacy and safety of this combined approach in Chinese CD patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Crohn's disease (CD) is a chronic granulomatous inflammatory disease that can affect the entire digestive tract, characterized by a protracted course and complex complications. Although the advent of biologics has significantly improved CD treatment outcomes, real-world data show that only about 30% of patients achieve mucosal healing with anti-TNF-α biologics (infliximab or adalimumab), representing a major therapeutic bottleneck. According to the international STRIDE-II consensus, mucosal healing is a key target in CD treat-to-target strategy and is closely associated with better long-term prognosis. In recent years, the role of dietary factors in CD management has gained increasing attention. Exclusive enteral nutrition (EEN) has demonstrated efficacy in inducing remission and mucosal healing in pediatric CD, but poor long-term adherence limits its application in adults. Based on this, oral dietary regimens mimicking EEN components (such as the Crohn's Disease Exclusion Diet, CDED) have become a new research focus. Preliminary data from our research team showed that compared to anti-TNF-α biologics alone, CDED combined with anti-TNF-α biologics resulted in significantly higher mucosal healing rates (42.9% vs 25.0%) and greater improvement in SES-CD scores at week 14, providing strong preliminary evidence for this combined approach to overcome the efficacy bottleneck.This is a single-center, prospective, randomized, open-label, controlled clinical trial conducted at the Inflammatory Bowel Disease Center, Department of Gastroenterology, Sixth Affiliated Hospital of Sun Yat-sen University. A total of 185 eligible adult Chinese patients with active CD will be enrolled and randomly assigned in a 1:1 ratio using SAS-generated random sequences with sealed envelope allocation concealment. The intervention group will receive standardized anti-TNF-α biologic therapy (infliximab 5mg/kg IV at weeks 0, 2, 6, and 14, or adalimumab subcutaneous injection at standard doses) combined with strict CDED. The dietary protocol includes detailed electronic and paper recipes specifying allowed grains (rice only), vegetables (avoiding nightshades), fruits, meats (recommended fish and poultry, limited red meat), oils (olive oil, coconut oil), and cooking methods (steaming, boiling, blanching), while strictly prohibiting ultra-processed foods, nuts, legumes, and butter. Patients will maintain daily food diaries via WeChat group and shared documents, with frequent supervision and guidance from researchers. The control group will receive the same anti-TNF-α biologic therapy alone without dietary intervention. The primary endpoint is mucosal healing rate at week 14 (defined as SES-CD score=0). Secondary endpoints include clinical remission rate (CDAI<150), endoscopic response rate (≥50% reduction in SES-CD), transmural healing rate (assessed by intestinal ultrasound), and adverse event incidence. Sample size calculation is based on preliminary data with superiority test assumption and 20% dropout rate. Data analysis will follow intention-to-treat (ITT) principle using SPSS 25.0 software.This study is innovative as it is the first in China to use a rigorous randomized controlled trial design to validate whether a specific, easily implementable, and cost-effective dietary intervention (CDED) can synergistically enhance the efficacy of standard biologic therapy, aiming to overcome the limitation of suboptimal mucosal healing rates with biologics alone. The findings are expected to provide high-level evidence for long-term dietary management in CD patients, forming a dietary intervention guidance program with Chinese characteristics, thereby improving patient outcomes and reducing healthcare burden.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Sixth afflicated of Sun-yat sen university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Diagnosis of Crohn's disease confirmed by endoscopy and histopathology, with active disease (CDAI ≥150).
  • Indicated for anti-TNF-α biologic therapy (infliximab or adalimumab) and naïve to these agents.
  • Willing and able to provide written informed consent.
  • Able to understand and comply with study requirements, including dietary intervention and scheduled follow-up.

Exclusion Criteria:

  • Presence of severe complications requiring surgical intervention (e.g., intestinal obstruction, intra-abdominal abscess, intestinal fistula).
  • Severe cardiac, hepatic, or renal insufficiency (e.g., Child-Pugh class C, or eGFR <30 mL/min/1.73 m²).
  • Active tuberculosis, active hepatitis B, HIV infection, or other severe opportunistic infections.
  • Current or history of malignancy, except non-melanoma skin cancer.
  • Pregnant or breastfeeding, or planning pregnancy during the study period.
  • Recent use (within 3 months) of other immunosuppressants (e.g., azathioprine, methotrexate) or high-dose corticosteroids (e.g., prednisone >20 mg/day).
  • Severe food allergies, celiac disease, severe malnutrition (BMI <18.5 kg/m²), or inability to adhere to CDED.
  • Concurrent participation in another clinical trial, or any condition that makes the patient unsuitable in the investigator's opinion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Crohn's Disease Exclusion Diet + Anti-TNF-α biologics
Participants in this group will receive anti-TNF-α biologics (infliximab 5mg/kg IV at weeks 0, 2, 6, and 14, or adalimumab subcutaneous injection at standard doses) combined with the Crohn's Disease Exclusion Diet (CDED). The CDED protocol includes detailed dietary guidance specifying allowed foods (rice, certain vegetables and fruits, fish, poultry, olive oil) and prohibited items (ultra-processed foods, nuts, legumes, butter). Patients will maintain daily food diaries and receive frequent supervision and guidance from researchers to ensure dietary compliance.
Other: Crohn's Disease Exclusion Diet
Participants will receive anti-TNF-α biologics (infliximab 5mg/kg IV at weeks 0, 2, 6, and 14, or adalimumab subcutaneous injection at standard doses) combined with the Crohn's Disease Exclusion Diet (CDED). The CDED protocol includes detailed dietary guidance specifying allowed foods (rice, certain vegetables and fruits, fish, poultry, olive oil) and prohibited items (ultra-processed foods, nuts, legumes, butter). Patients will maintain daily food diaries and receive frequent supervision and guidance from researchers to ensure dietary compliance throughout the 14-week study period. This combined intervention aims to evaluate whether CDED can synergistically enhance the efficacy of standard biologic therapy in achieving mucosal healing in Crohn's disease patients.
No Intervention: Anti-TNF-α biologics only
Participants in this group will receive anti-TNF-α biologics alone (infliximab 5mg/kg IV at weeks 0, 2, 6, and 14, or adalimumab subcutaneous injection at standard doses) without any dietary intervention. This group serves as the control to evaluate the additional benefit of CDED when combined with standard biologic therapy. No specific dietary restrictions or guidance will be provided to this group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mucosal healing rate at week 14 (SES-CD=0)
Time Frame: Week 14 (from baseline to week 14)
The proportion of patients achieving complete mucosal healing, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of 0 at week 14. SES-CD is a validated endoscopic scoring system that assesses the severity of mucosal inflammation in Crohn's disease, evaluating four parameters: ulcer size, ulcerated surface, affected surface, and presence of stenosis. A score of 0 indicates no visible inflammation or ulceration in the entire colon and terminal ileum, representing complete mucosal healing. Endoscopic assessments will be performed by experienced gastroenterologists who are blinded to treatment allocation.
Week 14 (from baseline to week 14)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical remission rate at week 14 (CDAI<150)
Time Frame: Week 14 (from baseline to week 14)
The proportion of patients achieving clinical remission, defined as a Crohn's Disease Activity Index (CDAI) score less than 150 at week 14. CDAI is a validated clinical scoring system that evaluates eight parameters including number of liquid stools, abdominal pain, general well-being, extraintestinal manifestations, use of antidiarrheals, abdominal mass, hematocrit, and body weight. A score below 150 indicates clinical remission. Assessments will be performed by trained clinicians at each study visit.
Week 14 (from baseline to week 14)
Endoscopic response rate at week 14 (SES-CD reduction ≥50%)
Time Frame: Week 14 (from baseline to week 14)
The proportion of patients achieving endoscopic response, defined as a reduction of at least 50% in the Simple Endoscopic Score for Crohn's Disease (SES-CD) from baseline to week 14. SES-CD evaluates four endoscopic parameters in five colonic segments: ulcer size, ulcerated surface, affected surface, and presence of stenosis. A 50% reduction in total score indicates significant improvement in mucosal inflammation. Endoscopic evaluations will be conducted by blinded gastroenterologists.
Week 14 (from baseline to week 14)
Transmural healing rate at week 14 (intestinal ultrasound)
Time Frame: Week 14 (from baseline to week 14)
The proportion of patients achieving transmural healing, assessed by intestinal ultrasound with a maximum bowel wall thickness ≤3mm and absence of inflammatory signs. Transmural healing is defined as the normalization of bowel wall thickness and the resolution of inflammatory changes in the entire intestinal wall layers. Ultrasound examinations will be performed by experienced radiologists blinded to treatment allocation using standardized protocols.
Week 14 (from baseline to week 14)
Incidence of adverse events during 14-week treatment period
Time Frame: Week 14 (from baseline to week 14)
The incidence of all adverse events including diet-related malnutrition, allergic reactions, infusion reactions, injection site reactions, opportunistic infections, and other treatment-emergent adverse events. Adverse events will be monitored throughout the study period and graded according to the National Institute on Aging (NIA) severity criteria. Causality assessment will be performed by investigators using standardized criteria.
Week 14 (from baseline to week 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021ZSLYEC-127-CDED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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