Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Anticipato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Yanling Wei, doctorate
- Numero di telefono: 15310354666
- Email: lingzi016@126.com
Backup dei contatti dello studio
- Nome: Dongfeng Chen, doctorate
- Numero di telefono: 13883032812
- Email: chendf1981@126.com
Luoghi di studio
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Chongqing
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Chongqing, Chongqing, Cina, 400042
- Reclutamento
- Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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).
Altri nomi:
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Comparatore 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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PHQ-9 score
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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SDS-score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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WBC
Lasso di tempo: 12 Weeks after treatment.
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leukocyte
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12 Weeks after treatment.
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CRP
Lasso di tempo: 12 Weeks after treatment.
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C-reactive protein
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12 Weeks after treatment.
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ESR
Lasso di tempo: 12 Weeks after treatment.
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erythrocyte sedimentation rate
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12 Weeks after treatment.
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PCT
Lasso di tempo: 12 Weeks after treatment.
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procalcitonin
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12 Weeks after treatment.
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IL-6
Lasso di tempo: 12 Weeks after treatment.
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interleukin-6
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12 Weeks after treatment.
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Intestinal flora
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Wei Y Ling, Army Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Inizio studio
Completamento primario (Anticipato)
Completamento primario
Completamento dello studio (Anticipato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- TMMU-DP-GI-FMT-003
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