Status:
UNKNOWN
Clinical Study of Selective Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome.
Lead Sponsor:
Yanling Wei
Conditions:
Irritable Bowel Syndrome Variant of Childhood
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
In order to clarify the effectiveness of precision fecal bacteria transplantation, we have independently developed precision transplantation capsules. Seventy patients with diarrhea-type irritable bow...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04890405
Start Date
May 20 2021
End Date
October 1 2022
Last Update
May 18 2021
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