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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral nutrition biscuits | Experimental | Addition of enteral nutritional biscuits to existing pharmacological treatment. |
|
| Conventional drug therapy | No Intervention | No nutritional intervention, use of existing medication. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral nutrition biscuits | Dietary Supplement | Addition of enteral nutritional biscuits to existing pharmacological treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2、4、8、12、24 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Induced remission success rate | Probability of success of intervention in inducing CD remission. | 2、4、8、12、24 weeks after intervention |
| Gastrointestinal Symptom Rating Scale (GSRS) score | Gastrointestinal Symptom Rating Scale (GSRS) score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping An | Contact | +8618627068700 | anping_05@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ping An | Renmin Hospital of Wuhan University | Principal Investigator |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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This is a prospective randomized controlled study divided into intervention and control groups.
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| 2、4、8、12、24 weeks after intervention |
| Gastrointestinal symptom remission | Gastrointestinal Symptom Rating Scale (GSRS) scores after 4 weeks of intervention. | 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. | 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. | 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. | 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. | 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. | 1、4、8、12、24 weeks after intervention |
| D007410 | Intestinal Diseases |