Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
2021年8月30日 更新者：Yanling Wei、Third Military Medical University
Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
This is a single-center trial, randomized, single-blind, placebo-controlled clinical intervention study which intends to explore the safety and effectiveness of FMT capsule for the treatment of ulcerative colitis with depression.
調査の概要
詳細な説明
A total of 54 patients with definite diagnosis of ulcerative colitis (light-to-moderate active period) with depressive state were included.
According to the random table, patients were randomly divided into the FMT capsule group and the placebo group, and received the FMT capsule and placebo interventions once a week for 4 consecutive times, respectively.
The patients were followed up at the 4th, 8th and 12th week of intervention, and a simple physical examination was performed to evaluate the patient's condition changes (abdominal pain degree score, diarrhea frequency, stool characteristics and extraintestinal manifestations such as skin and joints) and modified Mayo score , IBD-QOL scale, PHQ9, SDS, HADS, HAMA, HAMD scale, etc.
The improvement and effective colonization of the intestinal flora in the FMT capsule group or the placebo group of patients with depression and IBD were observed by methods such as 16S rRNA analysis of the intestinal flora In the 12th weeks.
研究の種類
介入
入学 (予想される)
54
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yanling Wei, doctorate
- 電話番号：15310354666
- メール：lingzi016@126.com
研究連絡先のバックアップ
- 名前：Dongfeng Chen, doctorate
- 電話番号：13883032812
- メール：chendf1981@126.com
研究場所
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Chongqing
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Chongqing、Chongqing、中国、400042
- 募集
- Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- The course of the disease is more than 6 months, and it is clearly diagnosed as ulcerative colitis with depression.【Diagnostic criteria: (2020) "JSGE Evidence-based Clinical Practice Guidelines: Inflammatory Bowel Disease" and "Chinese Mental Disorders Classification and Diagnostic Standards" (CCMD) -3) The relevant standards in the above, and also meet the improved Mayo score ≤ 10 points, PHQ9 score ≥ 5 points】;
- There is no restriction on men and women, aged between 18-65 years old;
- BMI is between 18-30kg/m2;
- Have basic reading comprehension skills;
- No other serious diseases such as heart, brain, lung, liver, and kidney are complicated;
- Have not traveled abroad in the past month, and have no history of alcoholism, drug abuse, or smelting;
- No antibiotics and probiotic preparations have been used within one month;
- Agree to participate in this study and sign an informed consent form.
Exclusion Criteria:
- Age <18 years old or >65 years old;
- Patients with unspecified ulcerative colitis;
- Authors with bipolar disorder, persistent mood disorder, and mania;
- Malignant tumors such as gastrointestinal infection, irritable bowel syndrome, bowel cancer and other gastrointestinal diseases;
- A history of gastrointestinal surgery;
- Patients during pregnancy and lactation;
- Complicated with obesity, hypertension, diabetes, heart disease, stroke and other serious chronic diseases (hereditary, metabolic, endocrine diseases);
- Infectious diseases: hepatitis B or C, HIV, syphilis (rapid recovery of positive plasma), Epstein-Barr virus and cytomegalovirus infection (IgM positive);
- Abnormal liver function: AST or ALT higher than 2 times the upper limit of normal; renal insufficiency: serum Cr higher than 1.5 times the upper limit of normal or eGFR<60ml/min; dyslipidemia (TC> 4.0 mmol/L, TG >2.0 mmol/L, LDL-c>2.5 mmol/L, HDL-c<1.0 mmol/L), CRP>8mg/L;
- Anticoagulation therapy;
- Patients who were participating in other clinical trials at the time of enrollment;
- Those who do not agree to join the group or have various factors affecting compliance and other people who are not suitable for participating in clinical trials.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Intestinal flora capsule(FMT)
The group includes 27patients.They will receive 16 capsules of intestinal bacteria each time, once a week, 4 times in a row.Each capsule contains 200mg of fecal bacteria.
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This research group has independently researched and created a human intestinal flora capsule based on "intestinal bacteria transplantation": Intestinal flora capsule, which has been declared a national invention patent (patent number: 2015103040414).
他の名前：
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プラセボコンパレーター：Placebo group
The group includes 27patients.They will receive 16 Placebo capsules each time, once a week, 4 times in a row.
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Each placebo capsule is the two-layer empty capsule shell of the Intestinal flora capsule, which is made of titanium dioxide and iron oxide yellow.
It is non-toxic and has the same appearance as the authentic Intestinal flora capsule.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PHQ-9 score
時間枠：12 Weeks after treatment.
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Patien Health Questionnare.The total score is 0-27 points, 0-4 points: no depression; 5-9 points: mild depression; 10-14 points: moderate depression; 15-27 points: severe depression.
The higher the score, the worse the depression.
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12 Weeks after treatment.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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SDS-score
時間枠：12 Weeks after treatment.
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Self-Rating Depression Scale.Standard total score: normal <53 points; 53-62 for mild depression; 63-72 for moderate depression; >72 for severe depression.The higher the score, the worse the depression.
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12 Weeks after treatment.
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HAMA-score
時間枠：12 Weeks after treatment.
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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.
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12 Weeks after treatment.
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HAMD-score
時間枠：12 Weeks after treatment.
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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 depression.
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12 Weeks after treatment.
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HADS-score
時間枠：12 Weeks after treatment.
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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.
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12 Weeks after treatment.
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GSRS-score
時間枠：12 Weeks after treatment.
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Gastrointestinal Symptom Rating Scale .
The score varies from 1 6 to 1 1 2 .
Higher scores suggest more severe gastrointestinal pathology .
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12 Weeks after treatment.
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Modified Mayo score
時間枠：12 Weeks after treatment.
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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.The higher the score, the more severe the condition.
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12 Weeks after treatment.
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IBD-QoL
時間枠：12 Weeks after treatment.
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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.Total score 0-224,The higher the score, the higher the quality of life.
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12 Weeks after treatment.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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WBC
時間枠：12 Weeks after treatment.
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leukocyte
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12 Weeks after treatment.
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CRP
時間枠：12 Weeks after treatment.
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C-reactive protein
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12 Weeks after treatment.
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ESR
時間枠：12 Weeks after treatment.
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erythrocyte sedimentation rate
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12 Weeks after treatment.
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PCT
時間枠：12 Weeks after treatment.
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procalcitonin
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12 Weeks after treatment.
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IL-6
時間枠：12 Weeks after treatment.
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interleukin-6
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12 Weeks after treatment.
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Intestinal flora
時間枠：12 Weeks after treatment.
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16S rRNA sequencing analysis and metagenomics analysis.
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12 Weeks after treatment.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Wei Y Ling、Army Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2021年9月10日
一次修了 (予想される)
2021年12月31日
研究の完了 (予想される)
2022年8月31日
試験登録日
最初に提出
2021年8月9日
QC基準を満たした最初の提出物
2021年8月30日
最初の投稿 (実際)
2021年9月1日
学習記録の更新
投稿された最後の更新 (実際)
2021年9月1日
QC基準を満たした最後の更新が送信されました
2021年8月30日
最終確認日
2021年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。