Table 1.

Randomised control studies of FMT in ulcerative colitis

Reference	No of subjects	Control/ Comparator	Treatment	Median / Mean Age(years)	Gender(% Male)	Average disease severity indices at baseline	Treatment Duration	Relevant study characteristics
Paramsothy et al* (2019)33	81	Placebo group (n = 40)	Treatment protocol Initial colonoscopic infusion followed by intensive FMT infusion enemas (n = 41) FMT preparation Pooled from multiple donors	FMT arm - 35.6 (27.8-48.9) Placebo arm - 35.4 (27.7-45.6)	FMT arm – 54% Placebo arm – 63%	FMT arm – 8 (average Total Mayo score) Placebo arm – 8 (average Total Mayo score)	FMT treatment 5 days/week for 8 weeks	Patients in the placebo group were eligible to receive open-label FMT after the double-blind study period 314 faecal samples collected from the patients at screening, every 4 weeks during treatment, and 8 weeks after the blinded or open-label FMT therapy
Moayyedi et al (2015)8	75	Placebo group (n = 37)	Treatment protocol Examined by flexible sigmoidoscopy followed by FMT infusion via enema (n = 38) FMT preparation Single donor per patient	FMT arm – 42.2 (±15.0) Placebo arm – 35.8 (±12.1)	FMT arm – 47% Placebo arm – 70%	FMT arm – 8.24 (±2.61) Total Mayo Clinic score Placebo arm – 7.86 (±2.28) Total Mayo Clinic score	FMT treatment 1 day/week for 6 weeks	Patients provided stool samples when the study began and during each week of FMT for microbiome analysis
Costello et al (2019)9	73	Autologous FMT control group (n = 35)	Treatment protocol Anaerobically prepared pooled donor FMT via colonoscopy followed by 2 enemas over 7 days (n = 38) FMT preparation Pooled from multiple donors	Donor FMT arm – 38.528, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52 Autologous FMT arm – 3525, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46	dFMT– 53% aFMT – 57%	dFMT arm – 7.2 (±1.7) Mean Total Mayo score aFMT – 7.4 (±1.9) Mean Total Mayo score	FMT treatment per week with patients monitored at 8 weeks and 12 months post-FMT	Open-label therapy was offered to autologous FMT participants at 8 weeks and they were followed up for 12 months Recipient stool samples were collected at baseline (week 0) and weeks 4, 8, and 52 for microbiome, metabolome, and faecal calprotectin assessment
Rossen et al (2015) †10	48	Autologous FMT control group (n = 25)	Treatment protocol Pre-treatment with bowel lavage followed by 2 duodenal infusions of a suspension of donor faeces via nasoduodenal tube (n = 23) FMT preparation Single donor per patient	Donor FMT arm – 4033-56 Autologous FMT arm – 4130, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48	dFMT arm – 47.8% aFMT arm – 44%	dFMT arm – 105, 6, 7, 8, 9, 10, 11 Median SCCAI score aFMT arm – 84, 5, 6, 7, 8, 9, 10, 11 Median SCCAI score	FMT treatment at the start of the study (week 0) and 3 weeks later (week 3)	Faecal samples were collected at baseline before bowel lavage and 6 and 12 weeks after FMT
Crothers et al (2021)13	12	Placebo group (n = 6)	Treatment protocol FMT induction by colonoscopy, followed by oral administration of frozen encapsulated cFMT (n = 6) FMT preparation Single donor for induction Multiple (2 pre-defined) donors during maintanence	FMT arm – 41 (±15) Placebo arm – 52 ±15)	FMT arm - 67% Placebo arm - 50%	FMT arm – 6.3 (±2.0) Mean Total Mayo score Placebo arm – 6.7 (±1.2) Mean Total Mayo score	Daily cFMT treatment for 12 weeks	Subjects were followed for 36 weeks and longitudinal clinical assessments Subjects in both arms of the study were pre-treated with antibiotics for 7 days prior to FMT (or placebo) procedure Subject stool samples were obtained weekly throughout the study period, beginning prior to antibiotic pre-treatment, and ending at 18-weeks follow-up
Pai et al (2021)12	25	Placebo group (n = 12)	Treatment protocol FMT administered by rectal enema (n=13) FMT preparation Multiple donors per patient (not pooled)	Overall 10.54, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 Individual arms not specified	Not specified	Not specified	Total 12 enemas (given biweekly)	Seven patients randomized to the placebo arm crossed over to the open-label arm after 30 weeks of placebo treatment
Haifer et al (2021)11	35	Placebo group (n=20)	Treatment protocol Six FMT capsules four times a day for 1 week, then six capsules twice daily for 1 week, followed by six capsules daily for the remaining 6 weeks. Each capsule contains 0.35g lyophilised stool. (n=15) FMT preparation Two donors, unclear if pooled	FMT arm - 37.1 (31.8–46.8) Placebo arm - 36.7 (25.1–42.0)	FMT arm – 60% Placebo arm – 45%	FMT arm - 55, 6, 7, 8, 9 median total Mayo score Placebo arm - 75, 6, 7, 8 median total Mayo core	8 weeks of capsules during induction, followed by 2 capsules daily for remaining 58 weeks for maintenance.	Antibiotic pre-treatment in both groups. 10 patients randomised to FMT arm with clinical response entered maintenance phase of the study - 4 assigned to FMT and 6 assigned to FMT withdrawal

^⁎Further post hoc microbiome and mycobiome analysis reported separately^32,33

^†Further post hoc microbiota analysis reported separately³¹

FMT-faecal microbiota transplantation, cFMT-capsulised faecal microbiota transplantation, dFMT-donor FMT, aFMT-autologous FMT, SCCAI-simple clinical colitis activity index.