- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05043818
A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The subjects voluntarily participated in the study and signed an informed consent form. Follow the steps below:
- When you come to the hospital or the first to second days of admission, collect general information: ID number, gender, age, height, weight, BMI, complete medical history including a) date of diagnosis, b) degree of disease, c) course of disease , D) previous surgery, e) previous hospitalization, f) comorbidities, g) current symptoms, h) extra-articular manifestations, i) endoscopic data, j) treatment drugs and other data.
- Scale evaluation (see Annex 1 for details): Screening related scales for anxiety and depression symptoms (PHQ9, SDS, HADS, HAMA, HAMD), inflammatory bowel disease quality of life scale (IBDQ), ulcerative colitis Patient's modified Mayo score/Simplified questionnaire surveys for patients with Crohn's disease such as CDAI score, stool characteristics, abdominal pain degree, and Gastrointestinal Symptom Scale (GSRS);
- Stool specimens were collected once during the visit to the hospital.
- The time, frequency and precautions for patients to go to the hospital for examination and follow-up.
This trial is a prospective observational study. When the patient comes to the hospital or on the first to the second day of admission, the subject will be given a full set of scales to check once, and a stool sample will be collected during the treatment. Co., Ltd. performed 16S rRNA sequencing to analyze the results of the bacterial flora once. In this study, there is no need for patients to come to the hospital for follow-up follow-up.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yanling Wei, MD
- Numéro de téléphone: 15310354666
- E-mail: Lingzi016@126.com
Lieux d'étude
-
-
Chongqing
-
Chongqing, Chongqing, Chine, 400042
- Department of Gastroenterology, Daping Hospital, The Third Military Medical University
-
Contact:
- Yanling Wei, MD
- Numéro de téléphone: 86-15310354666
- E-mail: lingzi016@126.com
-
Contact:
- Dongfeng Chen, MD
- Numéro de téléphone: 86-13883032812
- E-mail: chendf1981@126.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Definite diagnosis of inflammatory bowel disease【diagnostic criteria reference: (2020)JSGE Evidence-based clinical practice guidelines: inflammatory bowel disease】
- There is no restriction on men and women, aged 18-65 years old;
- No complicated other serious diseases such as heart, brain, lung, liver, kidney, etc., no mental illness, and normal communication skills;
- No antibiotics, Bifidobacterium, Bacillus subtilis and other probiotic preparations have been used within one month;
- Sign the informed consent form and agree to participate in this research.
Exclusion Criteria:
- Course of disease <6 months;
- Unspecified inflammatory bowel disease.
- Authors with bipolar disorder, persistent mood disorder, and mania;
- Patients with malignant tumors;
- Patients during pregnancy and lactation;
- Combined with hypertension, diabetes, heart disease, stroke or severe chronic disease (infectious, genetic, metabolic, internal Secretory diseases);
- Patients who cannot cooperate to complete the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
IBD patients with depression
|
IBD patients without depression
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
PHQ-9 score
Délai: 0 week
|
Patient Health Questionnaire-9. The score varies from 0 to 27, higher scores suggest more severe the depression.Total score is the sum of 9 corresponding numbers: 0-4 points: no depression; 5-9 points: mild depression; 10-14 points: moderate depression; 15-27 points: severe depression. |
0 week
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
SDS score
Délai: 0 week
|
Self-rating Depression Scale.
The score varies from 25 to 100.
Higher scores suggest more severe depression.
|
0 week
|
HAMA-score
Délai: 0 week
|
Hamilton Anxiety Scale.The total score is 0-56, among which, physical anxiety: 7-13 items; mental anxiety: 1-6 and 14 items.The higher the score, the greater the anxiety.
|
0 week
|
HAMD-score
Délai: 0 week
|
Hamilton Depression Scale.The total score is 0-35 points: >35 points: severe depression; >20 points: mild or moderate depression; 8-20 may have depression; <8 points: no depression.
The higher the score, the greater the anxiety.
|
0 week
|
HADS-score
Délai: 0 week
|
Hospital Anxiety and Depression Scale.It consists of 14 (7 anxiety and 7 depression-related) scoring items, all ranging from 0-21.
The higher the score, the more severe the anxiety and depression.
|
0 week
|
GSRS-score
Délai: 0 week
|
Gastrointestinal Symptom Rating Scale.
The score varies from 16 to 112.
High scores suggest more severe Gastrointestinal pathology.
|
0 week
|
Simplified CDAI score
Délai: 0 week
|
Simplified CDAI score for Crohn's disease: represents disease activity, <4 remission period 5~8 moderate activity> 9 heavy activity.
The higher the score, the more severe the condition.
|
0 week
|
Modified Mayo score for UC
Délai: 0 week
|
Modified Mayo score for ulcerative colitis: a total of 0-12 points, scores ≤ 2 points and no single sub-item score> 1 points to clinical remission, 3 to 5 points to mild activity, 6 to 10 points to moderate activity, 11 ~12 is divided into heavy activity.
|
0 week
|
IBD-QoL
Délai: 0 week
|
Quality of Life Analysis Table for Patients with Inflammatory Bowel Disease: There are 32 questions in total.
Each question has a different level of answer from 1 to 7, 1 generation The table has the heaviest degree, and 7 represents the least degree.
|
0 week
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Intestinal flora
Délai: 0 week
|
Use metagenomics technology to detect intestinal flora.
|
0 week
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yanling Wei, MD, Army Medical Center of PLA
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TMMU-DP-GI-IBD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .