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

NCT ID: NCT04890405

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2022-10-01

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 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.

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 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.

Conditions

Irritable Bowel Syndrome Variant of Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standardized FMT

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Precision Flora Transplantation

Intervention Type: COMBINATION_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.

Interventions

Standardized FMT

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.

Intervention Type: PROCEDURE

Precision Flora Transplantation

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanling Wei

OTHER

Sponsor Role: lead

Responsible Party

Yanling Wei

Department of Gastroenterology, Da ping Hospital, The Third Military Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yanling Wei

Role: PRINCIPAL_INVESTIGATOR

Army Medical Center of PLA

Central Contacts

Yanling Wei

Role: CONTACT

lingzi016@126.com

15310354666

Other Identifiers

TMMU-DP-GI-JZ-001

Identifier Type: -

Identifier Source: org_study_id