Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
30 de agosto de 2021 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
54
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yanling Wei, doctorate
- Número de telefone: 15310354666
- E-mail: lingzi016@126.com
Estude backup de contato
- Nome: Dongfeng Chen, doctorate
- Número de telefone: 13883032812
- E-mail: chendf1981@126.com
Locais de estudo
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Chongqing
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Chongqing, Chongqing, China, 400042
- Recrutamento
- Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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).
Outros nomes:
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Comparador de Placebo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PHQ-9 score
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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SDS-score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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WBC
Prazo: 12 Weeks after treatment.
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leukocyte
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12 Weeks after treatment.
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CRP
Prazo: 12 Weeks after treatment.
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C-reactive protein
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12 Weeks after treatment.
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ESR
Prazo: 12 Weeks after treatment.
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erythrocyte sedimentation rate
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12 Weeks after treatment.
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PCT
Prazo: 12 Weeks after treatment.
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procalcitonin
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12 Weeks after treatment.
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IL-6
Prazo: 12 Weeks after treatment.
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interleukin-6
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12 Weeks after treatment.
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Intestinal flora
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Wei Y Ling, Army Medical Center
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
10 de setembro de 2021
Conclusão Primária (Antecipado)
31 de dezembro de 2021
Conclusão do estudo (Antecipado)
31 de agosto de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
9 de agosto de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de agosto de 2021
Primeira postagem (Real)
1 de setembro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de setembro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de agosto de 2021
Última verificação
1 de agosto de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TMMU-DP-GI-FMT-003
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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