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Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders
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. The investigators prospectively enrolled functional children who met the Rome IV standard, and divided them into conventional treatment group or FMT group with open choice. The efficacy of the two groups was collected and compared at different time points, and the flora of children in the FMT group before and after treatment was collected to monitor FMT-related adverse reactions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fecal microbiota transplantation | Active Comparator | Fecal microbiota transplantation routes include the upper digestive tract, lower digestive tract, or oral fecal microbiota transplantation capsules |
|
| Conventional drug intervention | Sham Comparator | Conventional drugs include: probiotics and omeprazole, and cyproheptadine and moxapride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 8 weeks |
| self-reported severity of pain | change in self-reported severity of pain is defined as at least two Faces Pain Score (Wong-Baker Pain Rating Scale;0-no hurt,10-hurts worst for pain) | 4 weeks and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biao Zou, MD | Contact | 15871365900 | 464021552@qq.com | |
| Sainan Shu, MD, PhD | Contact | 13886011908 | shusainan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhihua Huang | Tongji Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | 430030 | China |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D003533 | Cyproheptadine |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
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Children with functional gastrointestinal disease were divided into two groups, one group was given FMT combined with conventional drug intervention, and the other group was given conventional drug intervention, including: probiotics and/or omeprazole, and/or cyproheptadine, and/or amitriptyline, and/or moxapride
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|
| Conventional drugs | Drug | Conventional drugs include probiotics and omeprazole, and cyproheptadine and moxapride |
|
|
| Mean number of bowel movements per week | change in the mean number of bowel movements per week | 4 weeks and 8weeks |
| 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 8 weeks |
| 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 8 weeks |
| 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 and/or 8 weeks |
| Adverse events | All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others | 2 weeks , 4 weeks and 8 weeks |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |