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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome Variant of Childhood
• Intervention / Treatment: Procedure: Standardized FMT; Combination product: Precision Flora 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 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
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanling Wei; Phone Number: 15310354666; Email: lingzi016@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Experimental: 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.	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-SSS score	Severity of irritable bowel syndrome.The score varies from 0 to 500. Higher scores suggest more severe condition.	12 Week after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission rate	Proportion of people in clinical remission after treatment	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.	0、2、4、8、12Week after treatment
IBS-QoL score	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	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	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	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	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	Use metagenomics technology to detect intestinal flora	0、2、4、8、12Week after treatment

Collaborators and Investigators

• Sponsor: Yanling Wei
• Investigators: Principal Investigator: Yanling Wei, Army Medical Center of PLA

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation; diarrhea; irritable bowel syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: TMMU-DP-GI-JZ-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No