Safety of fecal microbiota transplantation in Chinese children: A single-center retrospective study

Table 1 Patient and donor characteristics

	Item	Results
Patients	Total number of study patients	49
	Gender, male n (%)	27 (55.1)
	Age [mean ± SD (range), mo]	68.16 ± 53.09 (4-193)
	Follow-up duration [mean ± SD (range), mo]	23.14 ± 15.32 (1-55)
	Disease type
	Gastrointestinal disorder
	CDI1	33
	Chronic intractable diarrhea (without CD evidence)2	6
	Functional gastrointestinal disorder	1
	Nongastrointestinal disorder
	Metabolic syndrome	1
	NASH	2
	Eczema	2
	Others3	4
	Patients with single vs multiple FMTs
	Single	20
	Multiple (range of FMT rounds)	29 (2-11 rounds)
	Immunodeficiency	15
Donors	Total number	30
	Gender, male n (%)	11 (36.7)
	Age [mean ± SD (range), yr]	32.77 ± 8.266 (2-49)
	Relative genetic background, n (%)	46.7 (14)

¹CDI is Clostridium difficile infection in two primary immunodeficiency patients (VEO-IBD with IL10Ra gene mutation and IPEX with FOXP3 gene mutation), nine IBD patients on immunosuppressive agents and 18 recurrent CDI patients;

²Chronic intractable diarrhea without CD evidence in four primary immunodeficiency patients (one DNA ligase IV syndrome with LIG4 gene mutation and three undetermined immunodeficiency) and two cases of antibiotic-associated diarrhea;

³Other diseases include one case of systemic juvenile rheumatoid arthritis, two cases of hemophagocytic lymphohistiocytosis with Epstein-Barr virus infection and one case of Okuda syndrome with severe constipation. NASH: Non-alcoholic steatohepatitis; FMT: Fecal microbiota transplantation; IBD: Inflammatory bowel disease.

Table 2 Different categories of fecal microbiota transplantation in all rounds

Category	Sub-item	Number of AEs	Total rounds of FMT
Age group	0-12	1	12
	13-36	4	30
	37-72	5	22
	73	20	50
Route of administration	Nasogastric tube	5	20
	Nasal jejunal tube	19	58
	Enema	6	36
Number of FMT infusions	Single	23	88
	Multiple	7	26
Immune state	Immune deficiency	16	35
	Normal immune function	14	79

AEs: Adverse events; FMT: Fecal microbiota transplantation.

Table 3 Short-term adverse events n (%)

Upper gastrointestinal symptom	Lower gastrointestinal symptom	Other manifestation	Severe adverse event
Sore throat 1 (0.88)	Diarrhea 7 (6.14)	Fever 6 (5.26)	Hematemesis 1 (0.88)
Vomiting 6 (5.26)	Abdominal pain 8 (7.02)	Appetite decrease 1 (0.88)	Hematochezia 1 (0.88)
Nausea 2 (1.75)	Mucoid stool 1 (0.88)	Chest distress 1 (0.88)

Table 4 Potential factors influencing fecal microbiota transplantation adverse event occurrence

Item	Sub-item	χ2	P-value	Wald test	P-value
Gender	Male	0.456	0.499
	Female
Age group (m)	0-12	9.583	0.02	4.413	0.22
	13-36
	37-72
	73
Number of fecal microbiota transplantation infusions	Single	0.006	0.936
	Multiple
Route of administration	Nasogastric tube	2.988	0.224
	Nasal jejunal tube
	Enema
Disease type	Gastrointestinal disorder	2.182	0.14
	Nongastrointestinal disorder
Immune state	Immune deficiency	9.801	0.002	4.425	0.035
	Normal immune function
Donor genetic background	Relative	1.119	0.29
	Nonrelative