Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.
Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years;
Patients who have experienced failure of at least 3 conventional therapies for IBS;
Absence of red flags such as weight loss, hematochezia;
Pregnant, planning pregnancy or lactating;
Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
Immunodeficiency or treatment with immune-modulating medication;
Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry;
Single group
FMT
Other interventionFMT refers to transplanting healthy donor-derived microbiota to participants via oral capsule or injection of fecal suspension via nasojejunal tube.
Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks
IBS symptom severity scale (IBS-SSS) is used to evaluate change in IBS symptoms, with a score ranging from 0 to 500. Higher score means severer IBS symptom. Change in IBS-SSS score is obtained by evaluating the scale at baseline and 9 weeks (after three-time FMT).
Response rate at 9 weeks
Investigator ask participants a single question, "Compared to the way you felt before you entered the study, have you IBS symptoms over the past 7 days been: 1)"Substantially Worse"; 2)"Moderately Worse"; 3) Slightly Worse; 4)"No Change"; 5) Slightly Improved"; 6) Moderately Improved"; 7) Substantially Improved". Responder is defined as participants who report "moderately improved" or "substantially improved".
Change from baseline IBS symptom severity scale (IBS-SSS) score at 1 week, 1 month and 6 months
IBS symptom severity scale (IBS-SSS) is used to evaluate change in IBS symptoms, with a score ranging from 0 to 500. Higher score means severer IBS symptom. Change in IBS-SSS score is obtained by evaluating the scale at baseline and at 1 week (after first FMT), 1 month (three weeks after first FMT), and 6 months (4 months after three-time FMT).
Change from baseline Gastrointestinal Symptom Rating Scale (GSRS) score at 1 week, 1 month, 9 weeks and 6 months
Gastrointestinal symptom rating scale (GSRS) is used to evaluate change in gastrointestinal symptoms, with a score ranging from 15 to 105. Higher score means severer gastrointestinal symptoms. Change in IBS-SSS score is obtained by evaluating the scale at baseline, 1 week (after first FMT), 1 month (three weeks after first FMT), 9 weeks (after three-time FMT) and 6 months (4 months after three-time FMT).
Change from baseline IBS-Quality of Life (IBS-QoL) score at 1 month, 3 months and 6 months
IBS-Quality of Life (IBS-QoL) is a specific scale used to evaluate change in quality of life, with a score ranging from 0 to 100. Higher score indicates worse quality of life. Change in IBS-QoL score is obtained by evaluating the scale at baseline, 1 month (three weeks after first FMT), 3 months (three weeks after third FMT) and 6 months (4 months after three-time FMT). An over-14-point reduction is considered a significant improvement in quality of life.
Change from baseline Self-rating Anxiety Scale (SAS) score at 1 month, 3 months and 6 months
Self-rating Anxiety Scale (SAS) is used to evaluate change in IBS-related anxiety, with a score ranging from 25 to 100. Higher score indicates higher level of anxiety. Change in SAS score is obtained by evaluating the scale at baseline, 1 month (three weeks after first FMT), 3 months (three weeks after third FMT) and 6 months (4 months after three-time FMT).
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