Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders

Functional Gastrointestinal Disorders Clinical Trial

— FGIDs  

Official title:

Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753774
• Other study ID #: 63639582
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: October 2023
• Source: Tongji Hospital
• Contact: Biao Zou, MD
• Phone: 15871365900
• Email: 464021552[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and efficacy of FMT in Pediatric Functional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Biological:
• FMT
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

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Biao Zou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks and 8weeks
Primary	self-reported severity of pain	change in self-reported severity of pain is defined as at least two Faces Pain Score	4 weeks and 8weeks
Secondary	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	4 weeks and 8weeks
Secondary	Mean number of bowel movements per week	change in the mean number of bowel movements per week	4 weeks and 8weeks
Secondary	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.	4 weeks and 8weeks
Secondary	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.	4 weeks and 8weeks
Secondary	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.	4 weeks
Secondary	Adverse events	All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others	2 weeks