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A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression

6 september 2021 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The subjects voluntarily participated in the study and signed an informed consent form. Follow the steps below:

  1. 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.
  2. 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);
  3. Stool specimens were collected once during the visit to the hospital.
  4. 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.

Studietyp

Observationell

Inskrivning (Förväntat)

178

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Chongqing
      • Chongqing, Chongqing, Kina, 400042
        • Department of Gastroenterology, Daping Hospital, The Third Military Medical University
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients with inflammatory bowel disease diagnosed in the outpatient clinic or hospitalization of our hospital

Beskrivning

Inclusion Criteria:

  1. Definite diagnosis of inflammatory bowel disease【diagnostic criteria reference: (2020)JSGE Evidence-based clinical practice guidelines: inflammatory bowel disease】
  2. There is no restriction on men and women, aged 18-65 years old;
  3. No complicated other serious diseases such as heart, brain, lung, liver, kidney, etc., no mental illness, and normal communication skills;
  4. No antibiotics, Bifidobacterium, Bacillus subtilis and other probiotic preparations have been used within one month;
  5. Sign the informed consent form and agree to participate in this research.

Exclusion Criteria:

  1. Course of disease <6 months;
  2. Unspecified inflammatory bowel disease.
  3. Authors with bipolar disorder, persistent mood disorder, and mania;
  4. Patients with malignant tumors;
  5. Patients during pregnancy and lactation;
  6. Combined with hypertension, diabetes, heart disease, stroke or severe chronic disease (infectious, genetic, metabolic, internal Secretory diseases);
  7. Patients who cannot cooperate to complete the study.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
IBD patients with depression
IBD patients without depression

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PHQ-9 score
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
SDS score
Tidsram: 0 week
Self-rating Depression Scale. The score varies from 25 to 100. Higher scores suggest more severe depression.
0 week
HAMA-score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intestinal flora
Tidsram: 0 week
Use metagenomics technology to detect intestinal flora.
0 week

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Third Military Medical University

Utredare

  • Huvudutredare: Yanling Wei, MD, Army Medical Center of PLA

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 september 2021

Primärt slutförande (Förväntat)

1 september 2022

Avslutad studie (Förväntat)

1 september 2022

Studieregistreringsdatum

Först inskickad

9 augusti 2021

Först inskickad som uppfyllde QC-kriterierna

6 september 2021

Första postat (Faktisk)

14 september 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 september 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 september 2021

Senast verifierad

1 september 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • TMMU-DP-GI-IBD

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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