An interventional study of enteral nutrition biscuits in Crohn's Disease, sponsored by Ping An. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Ping An · Not applicable, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 52 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Ping An is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Addition of enteral nutritional biscuits to existing pharmacological treatment.
Dietary Supplement: enteral nutrition biscuits
No nutritional intervention, use of existing medication.
Addition of enteral nutritional biscuits to existing pharmacological treatment.
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.
Time frame: 2、4、8、12、24 weeks after intervention
Induced remission success rate
Probability of success of intervention in inducing CD remission.
Time frame: 2、4、8、12、24 weeks after intervention
Gastrointestinal Symptom Rating Scale (GSRS) score
Gastrointestinal Symptom Rating Scale (GSRS) score.
Time frame: 2、4、8、12、24 weeks after intervention
Gastrointestinal symptom remission
Gastrointestinal Symptom Rating Scale (GSRS) scores after 4 weeks of intervention.
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
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
Assess the 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
Assess the 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
Assess the 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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.