Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders (FGIDs)
Primary Purpose
Functional Gastrointestinal Disorders
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FMT
Sponsored by
About this trial
This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring Functional Gastrointestinal Disorders;, FMT;, Safety; efficacy, efficacy
Eligibility Criteria
Inclusion Criteria: The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children Exclusion Criteria: organic gastrointestinal disease (as established by medical history, blood routine, biochemistry, c-reaction protein, erythrocyte sedimentation rate, and fecal routine examinations.) other chronic disease growth failure
Sites / Locations
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fecal microbiota transplantation
Arm Description
fecal microbiota transplantation
Outcomes
Primary Outcome Measures
The efficacy of FMT in pediatric FGID
change in Gastrointestinal Symptom Rating Scale (GSRS), validated scale of GI symptoms. The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom.
self-reported severity of pain
change in self-reported severity of pain is defined as at least two Faces Pain Score
Secondary Outcome Measures
Change in Pittsburgh sleep quality index (PSQI)
PSQI assesses sleep quality in children. A higher score indicates poorer sleep quality. The PSQI will be assessed from baseline to 1 weeks and from baseline to 1 month. PSQI is scored from 0 to 21 points. The higher the score, the worse the sleep. PSQI≥8 was poor sleep quality, and 7 was the cut-off value
Mean number of bowel movements per week
change in the mean number of bowel movements per week
Bristol stool scale
Change in stool consistency assessed using the Bristol Stool Form Scale. The Bristol stool classification divides stool into seven categories. Types 1 and 2 indicate constipation; Types 3 and 4 are ideal for bowel movements, while types 5 to 7 indicate possible diarrhea.
Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)
IBS-SSS is a visual assessment scale (VAS) rating from 0 to 100, with total scores ranging from 0 to 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300.
gut microbial
Fecal 16S RNA or macrogene sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods.
Adverse events
All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05753774
Brief Title
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders
Acronym
FGIDs
Official Title
Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Biao Zou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety and efficacy of FMT in Pediatric Functional
Detailed Description
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Functional gastrointestinal disorders (FGIDs), also known as brain-intestinal interaction abnormalities, are associated with dynamic disorders, high visceral sensitivity, changes in mucosal and immune functions, changes in intestinal flora, and abnormal central nervous system regulatory functions. Fecal microbiota transplantation (FMT) is a process in which a presumed healthy and diverse microbiome is transplanted to a patient using a nasogastric tube, colonoscopy, or enema, or Fecal capsule to remodel the intestinal flora balance. At present, there are few clinical studies on the treatment of FGID in children with FMT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders
Keywords
Functional Gastrointestinal Disorders;, FMT;, Safety; efficacy, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fecal microbiota transplantation
Arm Type
Experimental
Arm Description
fecal microbiota transplantation
Intervention Type
Biological
Intervention Name(s)
FMT
Intervention Description
FMT is a technique in which intestinal microbiota are transferred from a healthy screened donor to a patient, with the goal being to introduce or restore a stable microbial community in the gut. FMT was given 1-3courses, 3-6 times per courses
Primary Outcome Measure Information:
Title
The efficacy of FMT in pediatric FGID
Description
change in Gastrointestinal Symptom Rating Scale (GSRS), validated scale of GI symptoms. The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom.
Time Frame
4 weeks and 8weeks
Title
self-reported severity of pain
Description
change in self-reported severity of pain is defined as at least two Faces Pain Score
Time Frame
4 weeks and 8weeks
Secondary Outcome Measure Information:
Title
Change in Pittsburgh sleep quality index (PSQI)
Description
PSQI assesses sleep quality in children. A higher score indicates poorer sleep quality. The PSQI will be assessed from baseline to 1 weeks and from baseline to 1 month. PSQI is scored from 0 to 21 points. The higher the score, the worse the sleep. PSQI≥8 was poor sleep quality, and 7 was the cut-off value
Time Frame
4 weeks and 8weeks
Title
Mean number of bowel movements per week
Description
change in the mean number of bowel movements per week
Time Frame
4 weeks and 8weeks
Title
Bristol stool scale
Description
Change in stool consistency assessed using the Bristol Stool Form Scale. The Bristol stool classification divides stool into seven categories. Types 1 and 2 indicate constipation; Types 3 and 4 are ideal for bowel movements, while types 5 to 7 indicate possible diarrhea.
Time Frame
4 weeks and 8weeks
Title
Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)
Description
IBS-SSS is a visual assessment scale (VAS) rating from 0 to 100, with total scores ranging from 0 to 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300.
Time Frame
4 weeks and 8weeks
Title
gut microbial
Description
Fecal 16S RNA or macrogene sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods.
Time Frame
4 weeks
Title
Adverse events
Description
All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children
Exclusion Criteria:
organic gastrointestinal disease (as established by medical history, blood routine, biochemistry, c-reaction protein, erythrocyte sedimentation rate, and fecal routine examinations.)
other chronic disease
growth failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biao Zou, MD
Phone
15871365900
Email
464021552@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sainan Shu, MD, PhD
Phone
13886011908
Email
shusainan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihua Huang
Organizational Affiliation
Tongji Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sainan Shu, professor
Phone
13886011908
Email
shusainan@163.com
First Name & Middle Initial & Last Name & Degree
Biao Zou
Phone
+8685726753
Email
464021552@qq.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders
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