- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05030064
Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
30 de agosto de 2021 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Anticipado)
54
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yanling Wei, doctorate
- Número de teléfono: 15310354666
- Correo electrónico: lingzi016@126.com
Copia de seguridad de contactos de estudio
- Nombre: Dongfeng Chen, doctorate
- Número de teléfono: 13883032812
- Correo electrónico: chendf1981@126.com
Ubicaciones de estudio
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Chongqing
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Chongqing, Chongqing, Porcelana, 400042
- Reclutamiento
- Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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).
Otros nombres:
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Comparador de placebos: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PHQ-9 score
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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SDS-score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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WBC
Periodo de tiempo: 12 Weeks after treatment.
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leukocyte
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12 Weeks after treatment.
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CRP
Periodo de tiempo: 12 Weeks after treatment.
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C-reactive protein
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12 Weeks after treatment.
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ESR
Periodo de tiempo: 12 Weeks after treatment.
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erythrocyte sedimentation rate
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12 Weeks after treatment.
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PCT
Periodo de tiempo: 12 Weeks after treatment.
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procalcitonin
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12 Weeks after treatment.
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IL-6
Periodo de tiempo: 12 Weeks after treatment.
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interleukin-6
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12 Weeks after treatment.
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Intestinal flora
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Wei Y Ling, Army Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
10 de septiembre de 2021
Finalización primaria (Anticipado)
31 de diciembre de 2021
Finalización del estudio (Anticipado)
31 de agosto de 2022
Fechas de registro del estudio
Enviado por primera vez
9 de agosto de 2021
Primero enviado que cumplió con los criterios de control de calidad
30 de agosto de 2021
Publicado por primera vez (Actual)
1 de septiembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
30 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TMMU-DP-GI-FMT-003
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .