Crohn's DiseaseNCT06362863
Evaluation of Enteral Nutrition Biscuits for Inducing Remission in Moderate-to-severe Crohn's Disease
A study testing enteral nutrition biscuits in people with Crohn's Disease, run by Ping An.
Trial summary
By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- enteral nutrition biscuits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 18 years old, gender is not limited
- Patients with a combination of clinical manifestations, laboratory examinations, endoscopy, imaging examinations and histopathological examinations to diagnose Crohn's disease for at least 6 months
- Patients with Crohn's disease with a CDAI score of > 220 and an HBI of ≥5
- Voluntarily signed written informed consent
Who cannot join
- Patients with newly diagnosed Crohn's disease, no history of treatment with 5-aminosalicylic acid, biological or immunological agents
- Current presence of an abscess or suspected abscess
- Positive results of stool culture or other intestinal pathogens
- Use of any antibiotics, prebiotics, probiotics, nutrition bars and enteral nutrition in the past 4 weeks
- Known hypersensitivity to any of the components administered in this study
- Severe infection (CTC AE> grade 2) within 4 weeks prior to the start of the study
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- Patients who have recently undergone digestive surgery (< 1 month) or have not been completely cured
- Patients with severe gastrointestinal problems (such as life-threatening intestinal obstruction, perforation, and bleeding) requiring immediate treatment
- Have an underlying medical condition that affects treatment
- Pregnant or lactating women
- Positive for human immunodeficiency virus
- Known history of active pulmonary tuberculosis. Subjects with suspected active tuberculosis should be examined for chest x-ray, sputum, and exclusion by clinical signs and symptoms
- Patients with untreated chronic hepatitis B or hepatitis B virus carriers with chronic hepatitis B virus DNA exceeding 500 IU/mL, or patients with active hepatitis C should be excluded. Patients with inactive HBsAg, treated and stable hepatitis B patients (HBV DNA <500 IU/mL), and cured hepatitis C patients may be enrolled. Subjects with positive hepatitis C virus antibodies are eligible to participate in the study only if they have a negative HCV RNA test result
- Known history of psychotropic substance abuse, alcoholism, and drug abuse
- Any condition that, in the opinion of the investigator, the participant should be excluded from the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Study to Evaluate the Efficacy of Enteral Nutrition Biscuits in Inducing Remission in Moderate to Severe Crohn's Disease
By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions.
Read the detailed description
This project is a randomized controlled study evaluating the effects of enteral nutrition biscuits during the induction and remission phases of moderate to severe Crohn's disease. The study subjects were patients with moderate to severe Crohn's disease, and the control group received conventional treatment with existing drugs; The experimental group added oral enteral nutrition biscuits to intervene on the basis of existing drugs. Evaluate the clinical response rates of patients at 2, 4, 8, 12, and 24 weeks after intervention; Nutritional status before and after intervention, incidence and severity of perianal lesions, and remission rate of small intestine and colon lesions.
- Conditions
- Crohn's Disease
- Being tested
- enteral nutrition biscuits
- Keywords
- enteral nutrition, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutrition biscuitsDietary supplement
Addition of enteral nutritional biscuits to existing pharmacological treatment.
| Study group | Role | What they receive |
|---|---|---|
| Enteral nutrition biscuits | Experimental | Addition of enteral nutritional biscuits to existing pharmacological treatment. Receives: Dietary Supplement: enteral nutrition biscuits |
| Conventional drug therapy | No intervention | No nutritional intervention, use of existing medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's disease activity index, CDAI
Assessment was performed using the Crohn's disease activity index (CDAI), with a clinical response defined as a CDAI score <150.
Measured: 2、4、8、12、24 weeks after intervention
Secondary outcomes (8)
Induced remission success rate
Probability of success of intervention in inducing CD remission.
Measured: 2、4、8、12、24 weeks after intervention
Gastrointestinal Symptom Rating Scale (GSRS) score
Gastrointestinal Symptom Rating Scale (GSRS) score.
Measured: 2、4、8、12、24 weeks after intervention
Gastrointestinal symptom remission
Gastrointestinal Symptom Rating Scale (GSRS) scores after 4 weeks of intervention.
Measured: 4 weeks after intervention
Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics
Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics.
Measured: 1、4、8、12、24 weeks after intervention
Incidence and severity of perianal lesions in both groups
Assess the incidence and severity of perianal lesions in both groups.
Measured: 1、8、24 weeks after intervention
Rate of endoscopic remission of small bowel and colon lesions in both groups
Assess the rate of endoscopic remission of small bowel and colon lesions in both groups.
Measured: 1、8、24 weeks after intervention
Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups
Assess the changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups.
Measured: 1、4、8、12、24 weeks after intervention
Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0
Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0.
Measured: 1、4、8、12、24 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized controlled study divided into intervention and control groups.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ping An
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ping An, Renmin Hospital of Wuhan University
- Investigators
- Ping An, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362863
- Sponsor's protocol ID
- WDRY2024-K027
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Evaluate the Efficacy of Enteral Nutrition Biscuits in Inducing Remission in Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT06362863
- Acronym / sponsor ID
- WDRY2024-K027
- Conditions
- Crohn's Disease
- Keywords
- enteral nutrition, Crohn's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ping AnUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions.
Detailed description
This project is a randomized controlled study evaluating the effects of enteral nutrition biscuits during the induction and remission phases of moderate to severe Crohn's disease. The study subjects were patients with moderate to severe Crohn's disease, and the control group received conventional treatment with existing drugs; The experimental group added oral enteral nutrition biscuits to intervene on the basis of existing drugs. Evaluate the clinical response rates of patients at 2, 4, 8, 12, and 24 weeks after intervention; Nutritional status before and after intervention, incidence and severity of perianal lesions, and remission rate of small intestine and colon lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective randomized controlled study divided into intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| Enteral nutrition biscuits | Experimental | Dietary Supplement: enteral nutrition biscuitsAddition of enteral nutritional biscuits to existing pharmacological treatment. |
| Conventional drug therapy | No intervention | –No nutritional intervention, use of existing medication. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥ 18 years old, gender is not limited
- Patients with a combination of clinical manifestations, laboratory examinations, endoscopy, imaging examinations and histopathological examinations to diagnose Crohn's disease for at least 6 months
- Patients with Crohn's disease with a CDAI score of > 220 and an HBI of ≥5
- Voluntarily signed written informed consent
Key exclusion criteria (15 listed)
- Patients with newly diagnosed Crohn's disease, no history of treatment with 5-aminosalicylic acid, biological or immunological agents
- Current presence of an abscess or suspected abscess
- Positive results of stool culture or other intestinal pathogens
- Use of any antibiotics, prebiotics, probiotics, nutrition bars and enteral nutrition in the past 4 weeks
- Known hypersensitivity to any of the components administered in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral nutrition biscuitsAddition of enteral nutritional biscuits to existing pharmacological treatment. | Dietary supplement | Enteral nutrition biscuits |
Primary outcome
Crohn's disease activity index, CDAI
Time frame: 2、4、8、12、24 weeks after intervention
Assessment was performed using the Crohn's disease activity index (CDAI), with a clinical response defined as a CDAI score <150.
8 secondary outcomes
Induced remission success rate
Time frame: 2、4、8、12、24 weeks after intervention
Gastrointestinal Symptom Rating Scale (GSRS) score
Time frame: 2、4、8、12、24 weeks after intervention
Gastrointestinal symptom remission
Time frame: 4 weeks after intervention
Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics
Time frame: 1、4、8、12、24 weeks after intervention
Incidence and severity of perianal lesions in both groups
Time frame: 1、8、24 weeks after intervention
Rate of endoscopic remission of small bowel and colon lesions in both groups
Time frame: 1、8、24 weeks after intervention
Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups
Time frame: 1、4、8、12、24 weeks after intervention
Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0
Time frame: 1、4、8、12、24 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping An principal investigator
Renmin Hospital of Wuhan University
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition biscuits in people with Crohn's Disease, run by Ping An.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping An (+8618627068700, anping_05@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crohn's disease activity index, CDAI (time frame: 2、4、8、12、24 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.