A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
6. september 2021 oppdatert av: Yanling Wei, Third Military Medical University
Inflammatory bowel disease (IBD) seriously affects the quality of life of patients.
During treatment, it is found that patients are often accompanied by a certain degree of psychological problems, such as depression, sensitivity, introversion, depression, and pessimistic disappointment.
Among them, anxiety and depression are the most common.
Through prospective observational research, statistics of the incidence of depression in inflammatory bowel disease in our hospital, comparison of the proportions of each subtype, screening of intestinal biomarkers in IBD patients with depression, and observation of inflammatory bowel disease with different The type and quantity of different intestinal flora in patients with severe depression, and the correlation between intestinal flora and depression.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Forventet)
178
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yanling Wei, MD
- Telefonnummer: 15310354666
- E-post: 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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Ta kontakt med:
- Yanling Wei, MD
- Telefonnummer: 86-15310354666
- E-post: lingzi016@126.com
-
Ta kontakt med:
- Dongfeng Chen, MD
- Telefonnummer: 86-13883032812
- E-post: chendf1981@126.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients with inflammatory bowel disease diagnosed in the outpatient clinic or hospitalization of our hospital
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
IBD patients with depression
|
|
IBD patients without depression
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intestinal flora
Tidsramme: 0 week
|
Use metagenomics technology to detect intestinal flora.
|
0 week
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Yanling Wei, MD, Army Medical Center of PLA
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. september 2021
Primær fullføring (Forventet)
1. september 2022
Studiet fullført (Forventet)
1. september 2022
Datoer for studieregistrering
Først innsendt
9. august 2021
Først innsendt som oppfylte QC-kriteriene
6. september 2021
Først lagt ut (Faktiske)
14. september 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TMMU-DP-GI-IBD
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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