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Table 4 Clinical studies

From: Effect of fecal microbiota transplant on symptoms of psychiatric disorders: a systematic review

Study Sample characteristics Study design Intervention Donor Measurement Key findings and conclusions
Cai et al. 2019 [66] 1 female MDD patient, 79 years old Pre- and post-intervention assessment Single time FMT via gastroscope 6 year-old grandson PHQ-9 • Six months after intervention PHQ-9 scores improved.
• Significant increase in Firmicutes counts and Bacteroides significant reduced
De Clerq et al. 2019 [67] 1 female AN patient, 26 years old Case report, pre- and post-intervention assessment Single duodenal FMT Unrelated female donor with BMI of 25 BMI, caloric intake • Increase in BMI post-intervention
• No significant differences in gut microbiota composition after FMT
Huang et al. 2019 [45] 30 (18 M, 12F) refractory IBS patients, Mean age: 44 years old Pre- and post intervention assessment with 1, 3, and 6 month follow-ups Two to three FMT procedures (done every other day) via colonoscopy Healthy volunteers aged 8–35 IBS-QOL, IBS-SSS, GSRS, HAM-A and HAM-D • Significantly improved GI symptoms and alleviated depression and anxiety as indicated by IBS-QOL, IBS-SSS, GSRS, HAM-A and HAM-D scores, 1 and 3 months post-FMT
• Increase in Verrucomincrobia and Euryarchaeota at phyla level and increase in Methanobrevibacter and Akkermansia at the genus level, at 1 month after FMT compared to before FMT
Mazzawi et al. [46] 13 (9 M, 4F) IBS patients, Mean age: 32 years old Open label, pilot study Single duodenal FMT via gastroscope Healthy donors, aged 20–42 IBS-SQ, IBS-SSS, EPQ-N-12, and HAD • Scores of all questionnaires improved significantly at all follow-up time points and lasted up to 28 weeks
• Patients’ microbiota compositions became more similar to donors after FMT
Mizuno et al. 2017 [44] 10 (7 M, 3F) refractory IBS patients, Mean age: 40.1 years old Single arm, open label, non-randomized study with 12-week follow-up Single time FMT via colonoscopy Healthy relatives in second-degree relationship, Mean age: 52 years HAM-A, HAM-D • The HAM-D score significantly improved 4 weeks after FMT but returned to the baseline level at 12 weeks
• When evaluated with HAM-A, the GI symptoms significantly improved from before FMT to 12 weeks after in responders, but not in non-responders
• Significant increase in microbial diversity from before treatment to week 4
• Significant relationship between diversity and response to treatment at week 4 but not before treatment
Xie et al. 2019 [47] 1 male MDD patient with alopecia and GI symptoms, 86 years old Case report, pre- and post-intervention assessment Six rounds of FMT via colonoscopy 22-year old healthy male donor HAM-D • Improved depressive symptoms
• Improved appetite and no abdominal pain or distension, increased BMI.
• Improved hair growth without any hair loss treatments
Kurokawa et al. 2018 [48] 17 (8 M, 9F) IBS patients, Mean age: 43.41 Single arm, non-randomized, open label, observational study Single time FMT, via colonoscopy Healthy relatives in second-degree relationship, Mean age: 51.41 years HAM-D and subscale of sleep-related items, HAM-A, and QIDS • Significant improvement in HAM-D total and sleep subscale score, HAM-A, and QIDS after FMT, at times even without GI symptoms improvement
• Significant increase in microbiome diversity after FMT
Johnsen et al. 2020 [49] 85 IBS (non-constipated) patients between 18 and 75 years of age Double-blind, Randomized Controlled Trial, Parallel group FMT (frozen or fresh) using health donors or using patient’s own feces, delivered to cecum of IBS patients via colonoscope Frozen or fresh feces from healthy donors Fatigue Impact Scale (FIS), IBS-QoL, IBS-SSS • Clinical effect on QoL and fatigue six months after treatment, with waning effect from six to twelve months,
• Transient treatmnet effect seen in individuals with other functional disorders.
• Absence of other self reported functional disorders and presence of depression at baseline is suggested to predict a lasting effect of FMT in QoL and fatigue, respectively