Clinical Study of Selective Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome.

Yanling Wei70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Irritable Bowel Syndrome Variant of Childhood

Interventions

Standardized FMTPROCEDURE

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.

Precision Flora TransplantationCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

IBS-SSS score

Severity of irritable bowel syndrome.The score varies from 0 to 500. Higher scores suggest more severe condition.

Time frame: 12 Week after treatment

Secondary Outcomes

Clinical remission rate

Proportion of people in clinical remission after treatment

Time frame: 2、4、8、12 Week after treatment

GSRS score

Gastrointestinal Symptom Rating Scale.The score varies from 16 to 112. Higher scores suggest more severe gastrointestinal pathology.