- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05043818
A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Yanling Wei, MD
- Telefonnummer: 15310354666
- E-mail: Lingzi016@126.com
Studiesteder
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Chongqing
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Chongqing, Chongqing, Kina, 400042
- Department of Gastroenterology, Daping Hospital, The Third Military Medical University
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Kontakt:
- Yanling Wei, MD
- Telefonnummer: 86-15310354666
- E-mail: lingzi016@126.com
-
Kontakt:
- Dongfeng Chen, MD
- Telefonnummer: 86-13883032812
- E-mail: chendf1981@126.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
IBD patients with depression
|
IBD patients without depression
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
PHQ-9 score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
SDS score
Tidsramme: 0 week
|
Self-rating Depression Scale.
The score varies from 25 to 100.
Higher scores suggest more severe depression.
|
0 week
|
HAMA-score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Intestinal flora
Tidsramme: 0 week
|
Use metagenomics technology to detect intestinal flora.
|
0 week
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Yanling Wei, MD, Army Medical Center of PLA
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TMMU-DP-GI-IBD
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