- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05030064
Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
30 augusti 2021 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
54
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Yanling Wei, doctorate
- Telefonnummer: 15310354666
- E-post: lingzi016@126.com
Studera Kontakt Backup
- Namn: Dongfeng Chen, doctorate
- Telefonnummer: 13883032812
- E-post: chendf1981@126.com
Studieorter
-
-
Chongqing
-
Chongqing, Chongqing, Kina, 400042
- Rekrytering
- Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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).
Andra namn:
|
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Placebo-jämförare: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PHQ-9 score
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
SDS-score
Tidsram: 12 Weeks after treatment.
|
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
Tidsram: 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.
|
12 Weeks after treatment.
|
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HAMD-score
Tidsram: 12 Weeks after treatment.
|
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.
|
12 Weeks after treatment.
|
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HADS-score
Tidsram: 12 Weeks after treatment.
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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WBC
Tidsram: 12 Weeks after treatment.
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leukocyte
|
12 Weeks after treatment.
|
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CRP
Tidsram: 12 Weeks after treatment.
|
C-reactive protein
|
12 Weeks after treatment.
|
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ESR
Tidsram: 12 Weeks after treatment.
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erythrocyte sedimentation rate
|
12 Weeks after treatment.
|
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PCT
Tidsram: 12 Weeks after treatment.
|
procalcitonin
|
12 Weeks after treatment.
|
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IL-6
Tidsram: 12 Weeks after treatment.
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interleukin-6
|
12 Weeks after treatment.
|
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Intestinal flora
Tidsram: 12 Weeks after treatment.
|
16S rRNA sequencing analysis and metagenomics analysis.
|
12 Weeks after treatment.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Wei Y Ling, Army Medical Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
10 september 2021
Primärt slutförande (Förväntat)
31 december 2021
Avslutad studie (Förväntat)
31 augusti 2022
Studieregistreringsdatum
Först inskickad
9 augusti 2021
Först inskickad som uppfyllde QC-kriterierna
30 augusti 2021
Första postat (Faktisk)
1 september 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 september 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 augusti 2021
Senast verifierad
1 augusti 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TMMU-DP-GI-FMT-003
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .