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Inflammatory Bowel DiseasesNCT05043818

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

An observational study of Inflammatory Bowel Diseases, run by Third Military Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Inflammatory Bowel Diseases
How many people
178 participants
Where
1 siteChina
Study dates
Sep 2021to Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Yanling Wei, MD contact

15310354666

Lingzi016@126.com

China1 site

  • Department of Gastroenterology, Daping Hospital, The Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

    Dongfeng Chen, MD, 86-13883032812, chendf1981@126.com

    Yanling Wei, MD, 86-15310354666, lingzi016@126.com

Other trials in China

About this study

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.

Read the detailed description

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.

Keywords
Ulcerative Colitis, Crohn's Disease，Anxiety ， Depression
Medical subject headings
Inflammatory Bowel Diseases, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Other

    This study is an observational study and does not involve intervention.When the patient comes to the hospital or on the first to the second day of admission, the subject will be given a full scale check once（Screening related scales for anxiety and depression symptoms (PHQ9, SDS, HADS, HAMA, HAMD), inflammatory bowel disease quality of life scale (IBDQ), modified Mayo score for patients with ulcerative colitis/ simplified CDAI score for patients with Crohn's disease , Stool characteristics, degree of abdominal pain, gastrointestinal symptom scale (GSRS), etc.）. The stool sample will be collected once and 16S rRNA sequencing.

Study groups in NCT05043818
Study groupRoleWhat they receive
IBD patients with depressionIBD patients with depression
IBD patients without depressionIBD patients without depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PHQ-9 score

    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.

    Measured: 0 week

Secondary outcomes (8)

  1. SDS score

    Self-rating Depression Scale. The score varies from 25 to 100. Higher scores suggest more severe depression.

    Measured: 0 week

  2. HAMA-score

    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.

    Measured: 0 week

  3. HAMD-score

    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.

    Measured: 0 week

  4. HADS-score

    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.

    Measured: 0 week

  5. GSRS-score

    Gastrointestinal Symptom Rating Scale. The score varies from 16 to 112. High scores suggest more severe Gastrointestinal pathology.

    Measured: 0 week

  6. Simplified CDAI score

    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.

    Measured: 0 week

  7. Modified Mayo score for UC

    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.

    Measured: 0 week

  8. IBD-QoL

    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.

    Measured: 0 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05043818
Sponsor's protocol ID
TMMU-DP-GI-IBD
Status last verified
Sep 2021
First submitted
9 Aug 2021
Last updated
14 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases, run by Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanling Wei, MD (15310354666, Lingzi016@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PHQ-9 score (time frame: 0 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05043818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.

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