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

NCT04890405 | Unknown

• 1 other identifier: TMMU-DP-GI-JZ-001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome Variant of Childhood

Keywords

irritable bowel syndrome; diarrhea; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical remission rate

  2、4、8、12 Week after treatment

• GSRS score

  0、2、4、8、12Week after treatment

• IBS-QoL score

  0、2、4、8、12Week after treatment

• PHQ-9

  0、2、4、8、12Week after treatment

• GAD-7

  0、2、4、8、12Week after treatment

Study Arms (2)

FMT group

ACTIVE COMPARATOR

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

JZ group

EXPERIMENTAL

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

Interventions

Standardized FMT 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.

FMT group

Precision Flora Transplantation 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.

JZ group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yanling Wei: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanling Wei

  Army Medical Center of PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanling Wei

CONTACT

15310354666; lingzi016@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of the scale does not know the grouping of patients when assessing the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Gastroenterology, Da ping Hospital, The Third Military Medical University

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

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 18, 2021
• Study Start: May 20, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: May 18, 2021

Record last verified: 2021-05