Based on the Special Disease Management of Crohn's Disease Diet Studies
6. december 2021 opdateret af: Second Affiliated Hospital, School of Medicine, Zhejiang University
Based on the Special Disease Management of Crohn's Disease Diet Studies --a Multicenter, Randomized, Controlled and Open Label Study
This project plans to develop a new diet therapy suitable for China -- CD-C-food, which is more in line with the common diet of Chinese patients' eating habits and economic conditions, and its expected therapeutic effect and influence on intestinal microorganism are similar to that of EEN.
In order to explore the influence of intestinal microorganisms and their metabolites on the clinical remission effect and inflammatory response of patients with CD-C-Food, and to reveal the possible internal mechanism， a randomized control of adult subjects with a healthy CD-Chinese-food diet, treatment group of CD patients and animal model will be conducted by using intestinal microbiome, bacterial metabolite analysis, inflammatory factors detection and other technical means.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Exclusive Enteral Nutrition (EEN) is the only established dietary treatment for children with CD.Changes in diet affect the amount of short-chain fatty acids and branched-chain fatty acids produced by changing the composition of intestinal flora, leading to changes in intestinal state.Through the long-term clinical observation of our team, most patients with CD can achieve stable remission by removing the processed food and screening the corresponding food by combining the characteristics of Chinese diet with the food intolerance detection method.
So, what kind of diet is suitable for the treatment of CD patients in China?
The CD-Treat program, replacing the Western diet with Chinese diet, so as to design an individualized program CD-Chinese-food (CD-C-food) that is consistent with the eating habits of Chinese patients with CD.
By comparing the effects of this individualized diet with EEN on inducing and maintaining remission in CD patients.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
5
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Hangzhou
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Zhengzhou, Hangzhou, Kina, 310000
- Rekruttering
- Second Affiliated Hospital Zhejiang University School of Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 15 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The trial was carried out in 6 IBD center hospitals in China.
The heads of IBD centers in all hospitals are members of the CCCF Academic Committee.
A total of 200 IBD cases are planned to be enrolled in 6 centers.
Beskrivelse
Inclusion Criteria:
- patients who are clinically diagnosed as stable CD; the diagnosis of CD has evidence of clinical manifestations and endoscopy, and was confirmed by histopathological report, referring to the consensus opinion on the diagnosis and treatment of inflammatory bowel disease in 2018. CDAI (Crohn's disease activity index)<150 points is regarded as clinical remission.
- Have reading ability, can access the Internet, use mobile phone WeChat and use application (APP) software with the assistance of oneself or family members;
Exclusion Criteria:
- Active patients (referring to CDAI greater than 150);
- CD patients who currently need or expect surgical intervention during the study period.
- CD patients with symptoms or signs of perforation such as abdominal abscess, intestinal fistula, etc.
- Patients with complete intestinal obstruction or fibrous stenosis with pre-stenosis dilation that require surgery to relieve the obstruction.
- CD patients with colorectal tumors. Those who have EN contraindications (active gastrointestinal bleeding, severe esophageal and gastric varices, intestinal obstruction, abdominal cavity syndrome, etc.).
- Pregnancy and breastfeeding patients.
- Severe hemodynamics, unstable vital signs, or the presence of rapid progression or end-stage disease, are expected to die during the course of the study.
- Patients diagnosed with short bowel syndrome or with ileostomy or colostomy.
- Patients with severe liver and kidney dysfunction, active infection, or other reasons (such as previous infliximab anaphylactic shock) cannot tolerate the treatment drugs used in this study.
- The patient is allergic to known ingredients of enteral nutrition or has no previous EEN for 12 weeks.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
CD-C-Food group
During the first 3 months，participants received EEN；In the second 3months , CD-C-Food group received received CD-C-food .
|
CD patients combined with the characteristics of Chinese diet, remove the refined food, and combined with food intolerance detection method to check the corresponding food
|
|
EEN group
During the period, participants received EEN for 6 months.
|
EEN goup received EEN continuously for 6 moths
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Remission rate of patients Maintain difference in remission rate
Tidsramme: 6 months
|
Clinical remission rate（Crohn's Disease Activity Index<150)
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life scale for IBD (inflammatory bowel disease) patients
Tidsramme: 6 months
|
Total score is 145, the higher scores mean a better outcome.
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6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. august 2020
Primær færdiggørelse (Forventet)
1. august 2023
Studieafslutning (Forventet)
1. december 2023
Datoer for studieregistrering
Først indsendt
14. november 2019
Først indsendt, der opfyldte QC-kriterier
21. juli 2021
Først opslået (Faktiske)
26. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. december 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2019-257
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