- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04890405
Clinical Study of Selective Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome.
17 maj 2021 uppdaterad av: Yanling Wei
Clinical Comparative Study of Precision Flora Transplantation and Standardized Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome.
In order to seek a more precise and convenient treatment, we made a self-made precise transplant capsule that is effective against diarrhea.
Compared with standardized fecal microbiota transplantation transplantation on the treat of diarrhea-type irritable bowel syndrome.
To observe the similarities and differences of the effect between the two treatment methods on the disease.
and the changes in intestinal bacteria was also observed.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
In order to clarify the effectiveness of precision fecal bacteria transplantation, we have independently developed precision transplantation capsules.
Seventy patients with diarrhea-type irritable bowel syndrome were selected and randomly divided into 2 groups.
The patients in the first group were treated with standard fecal bacteria transplantation once, and the patients in other group were treated with precision transplantation capsules for 28 days.
The clinical symptoms of the patients of the two groups were observed before and 2, 4, 8, 12, 24, and 48 weeks after the treatment, and stool samples were collected for intestinal flora detection.
The purpose is to observe and compare the efficacy of the two treatment methods and their influence on the intestinal flora.
Studietyp
Interventionell
Inskrivning (Förväntat)
70
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
- Telefonnummer: 15310354666
- E-post: lingzi016@126.com
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 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Male or female, aged 18 ~ 75 years.
- Patients who meet the diagnostic criteria of Rome IV of Irritable Bowel Syndrome and are definitely diagnosed as IBS-D.
- IBS has been diagnosed for more than 6 months, and has been treated with conventional drugs without obvious curative effect or repeated attacks.
- No other serious diseases, no mental disorders, and normal communication skills.
- Sign informed consent and agree to participate in this study.
- No antibiotics and probiotics were used within one month.
Exclusion Criteria:
- Patients are unwilling to participate in this study.
- Other serious diseases of heart, liver, kidney, respiration, digestion, blood and endocrine system.
- Combined with intestinal double infection, such as CDI, enterohemorrhagic Escherichia coli, Salmonella, Shigella, Campylobacter, plague, cytomegalovirus, etc.
- Liver function is significantly abnormal or has the following history of liver disease: AST or ALT is higher than 2 times of the upper limit of normal value, history of liver cirrhosis and hepatic encephalopathy, history of esophageal varices or history of portal shunt.
- There is evidence of renal function damage or the following history of kidney disease: serum creatinine is 1.5 times higher than the upper limit of normal value; History of dialysis; Or a history of nephrotic syndrome.
- Patients with various acute infections, tumors, severe arrhythmia, mental system disorders, and drug or alcohol addicts.
- History of abdominal surgery (except appendicitis, cholecystitis, caesarean section and hysterectomy).
- Those who were allergic to capsule drugs or contraindications.
- Lactose intolerance.
- Clinical researchers who are engaged in other related irritable bowel syndrome at the time of enrollment or within 3 months before enrollment.
- It is difficult to complete the follow-up, or various factors affecting the compliance.
- Pregnant or lactating women.
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: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: FMT group
Standardized FMT once.Extract all the flora from the feces provided by the donor to make fecal bacteria transplant capsules.
The patient took orally on an empty stomach, each time using 3.2g of fecal bacteria.
|
The group includes 35 patients.
They will receive standardized FMT.
Fecal bacteria capsules are used for fecal bacteria transplantation, 16 capsules are used each time, each capsule contains 200mg of fecal bacteria, and it is used orally.
It was given only once.
|
Experimentell: JZ group
1.6g Po perday,for 28 days.
probiotics that are effective against diarrhea were selected to make precise flora capsules, which are taken when the patient is on an empty stomach, once a day, using 1.6 g of bacteria per day, orally for 28 consecutive days.
|
The group includes 35 patients.
They will receive Precision Flora Transplantation.
They were used self-developed precision transplant capsules for precision flora transplantation.
4 capsules are used each time.
Each capsule contains 400mg of various probiotics effective against diarrhea.
It is used orally, once a day,for 28 days.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
IBS-SSS score
Tidsram: 12 Week after treatment
|
Severity of irritable bowel syndrome.The score varies from 0 to 500.
Higher scores suggest more severe condition.
|
12 Week after treatment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Clinical remission rate
Tidsram: 2、4、8、12 Week after treatment
|
Proportion of people in clinical remission after treatment
|
2、4、8、12 Week after treatment
|
GSRS score
Tidsram: 0、2、4、8、12Week after treatment
|
Gastrointestinal Symptom Rating Scale.The score varies from 16 to 112.
Higher scores suggest more severe gastrointestinal pathology.
|
0、2、4、8、12Week after treatment
|
IBS-QoL score
Tidsram: 0、2、4、8、12Week after treatment
|
Quality of life score for IBS patients.The score varies from 0 to 136.
Higher scores suggest greater impact of disease on life
|
0、2、4、8、12Week after treatment
|
PHQ-9
Tidsram: 0、2、4、8、12Week after treatment
|
Patient Health Questionnaire-9.The score varies from 0 to 27.
Higher scores suggest more severe the depression
|
0、2、4、8、12Week after treatment
|
GAD-7
Tidsram: 0、2、4、8、12Week after treatment
|
Generalized Anxiety Scale-7.The score varies from 0 to 21.
Higher scores suggest heavier the anxiety.
|
0、2、4、8、12Week after treatment
|
SAS
Tidsram: 0、2、4、8、12Week after treatment
|
Self-rating Anxiety Scale.The score varies from 25 to 100.
Higher scores suggest greater degree of anxiety.
|
0、2、4、8、12Week after treatment
|
SDS
Tidsram: 0、2、4、8、12after treatment
|
Self-rating Depression Scale.The score varies from 25 to 100.
Higher scores suggest more severe depression.
|
0、2、4、8、12after treatment
|
Intestinal flora
Tidsram: 0、2、4、8、12Week after treatment
|
Use metagenomics technology to detect intestinal flora
|
0、2、4、8、12Week after treatment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Yanling Wei, Army Medical Center of PLA
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)
20 maj 2021
Primärt slutförande (Förväntat)
1 oktober 2021
Avslutad studie (Förväntat)
1 oktober 2022
Studieregistreringsdatum
Först inskickad
5 maj 2021
Först inskickad som uppfyllde QC-kriterierna
17 maj 2021
Första postat (Faktisk)
18 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2021
Senast verifierad
1 maj 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TMMU-DP-GI-JZ-001
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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