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

Primary Purpose

Irritable Bowel Syndrome Variant of Childhood

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Standardized FMT

Precision Flora Transplantation

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome Variant of Childhood focused on measuring irritable bowel syndrome, diarrhea, Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FMT group

JZ group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

IBS-SSS score

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

Secondary Outcome Measures

Clinical remission rate

Proportion of people in clinical remission after treatment

GSRS score

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

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

PHQ-9

Patient Health Questionnaire-9.The score varies from 0 to 27. Higher scores suggest more severe the depression

GAD-7

Generalized Anxiety Scale-7.The score varies from 0 to 21. Higher scores suggest heavier the anxiety.

SAS

Self-rating Anxiety Scale.The score varies from 25 to 100. Higher scores suggest greater degree of anxiety.

SDS

Self-rating Depression Scale.The score varies from 25 to 100. Higher scores suggest more severe depression.

Intestinal flora

Use metagenomics technology to detect intestinal flora

Full Information

NCT ID

NCT04890405

First Posted

May 5, 2021

Last Updated

May 17, 2021

Sponsor

Yanling Wei

1. Study Identification

Unique Protocol Identification Number

NCT04890405

Brief Title

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

Official Title

Clinical Comparative Study of Precision Flora Transplantation and Standardized Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 20, 2021 (Anticipated)

Primary Completion Date

October 1, 2021 (Anticipated)

Study Completion Date

October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yanling Wei

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome Variant of Childhood

Keywords

irritable bowel syndrome, diarrhea, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Diarrhea-type irritable bowel syndrome patients were randomly divided into 2 groups, and each group was given a different treatment method

Masking

Outcomes Assessor

Masking Description

The assessor of the scale does not know the grouping of patients when assessing the patient.

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FMT group

Arm Type

Active Comparator

Arm Description

Arm Title

JZ group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Standardized FMT

Intervention Description

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

Combination Product

Intervention Name(s)

Precision Flora Transplantation

Intervention Description

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.

Primary Outcome Measure Information:

Title

IBS-SSS score

Description

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 Outcome Measure Information:

Title

Clinical remission rate

Description

Proportion of people in clinical remission after treatment

Time Frame

2、4、8、12 Week after treatment

Title

GSRS score

Description

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

Time Frame

0、2、4、8、12Week after treatment

Title

IBS-QoL score

Description

Quality of life score for IBS patients.The score varies from 0 to 136. Higher scores suggest greater impact of disease on life

Time Frame

0、2、4、8、12Week after treatment

Title

PHQ-9

Description

Patient Health Questionnaire-9.The score varies from 0 to 27. Higher scores suggest more severe the depression

Time Frame

0、2、4、8、12Week after treatment

Title

GAD-7

Description

Generalized Anxiety Scale-7.The score varies from 0 to 21. Higher scores suggest heavier the anxiety.

Time Frame

0、2、4、8、12Week after treatment

Title

SAS

Description

Self-rating Anxiety Scale.The score varies from 25 to 100. Higher scores suggest greater degree of anxiety.

Time Frame

0、2、4、8、12Week after treatment

Title

SDS

Description

Self-rating Depression Scale.The score varies from 25 to 100. Higher scores suggest more severe depression.

Time Frame

0、2、4、8、12after treatment

Title

Intestinal flora

Description

Use metagenomics technology to detect intestinal flora

Time Frame

0、2、4、8、12Week after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanling Wei

Phone

15310354666

lingzi016@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanling Wei

Organizational Affiliation

Army Medical Center of PLA

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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