Table 2.

Clinical effects of FMT treatment to patients with chronic pouchitis.

Author and Year	Study Type	Patient Population	Sample Size	FMT Treatment	Route	Dosage	Clinical Response (Reduction in PDAI ≥3)	Clinical Remission (Reduction in PDAI ≥3 and Total of <7)	Endoscopic Outcomes	Histologic Outcomes	Adverse Events	Follow-Up
Fang et al., 2016	Case report	Chronic antibiotic resistant pouchitis	1	Single FMT	Sigmoidoscopy (delivered 40 cm into the afferent limb and pouch body)	Stool mixed with saline and diluted to 250 mL	1/1 after 3 months (cPDAI decreased from 6 at baseline to 0)	1/1 after 3 months (cPDAI decreased from 6 at baseline to 0)	NA	NA	No reported adverse events.	3 months
Herfarth et al., 2019	RCT with open-label follow-up	Chronic antibiotic dependent pouchitis >4 weeks. mPDAI ≥5	6 (FMT (4) Placebo (2)). 5 received open-label FMT afterwards	Single endoscopic FMT followed by daily oral encapsulated FMT for 2 weeks	Sigmoidoscopy and oral capsules	eFMT (2 × 30 mL, total of 24 g donor stool) and 6 capsules daily consisting of 4.2 g donor stool	1/6 (Four patients receiving primary FMT and two patients receiving open-label FMT included)	1/6 (clinical PDAI 1 and no need for antibiotics)	NA	NA	No FMT related safety events were observed.	16 weeks
Kousgaard et al., 2020	Cohort (open-label pilot study)	Chronic pouchitis (≥3 episodes of pouchitis within the last year)	9	14 days of daily self-administered FMT	Enema	20 g fecal material diluted in 100 mL saline	3/9 after four weeks	3/9 after four weeks	Mean ePDAI of 3.2 at baseline decreased to 2.2 after four weeks	Mean hPDAI of 1.7 decreased to 1.0 after four weeks	7/9 patients reported adverse events while treated. Abdominal pain (5), uncomfortable (2), nausea (2), fever (2), bloating (1), dizziness (1), and fatigue (1).	6 months
Landy et al., 2015	Cohort (pilot study)	Chronic pouchitis with current PDAI ≥ 7	8	Single FMT	Nasogastric	30 mL of fecal-saline solution followed by 50 mL saline	2/8 after 4 weeks	0/8 after 4 weeks	Mean ePDAI of 5 at both baseline and after 4 weeks	Mean hPDAI of 3 at baseline decreased to 2 after four weeks	Nausea (3), bloating (2), vomiting (1), fever (1). All transient (<24 h).	4 weeks
Nishida et al., 2019	Case series	Chronic pouchitis with current PDAI ≥7	3	Single FMT	Colonoscopy	150–200 g donor stool mixed with 350–500 mL sterile saline	1/3 after 8 weeks	0/3 after 8 weeks	NA	NA	No reported adverse events.	8 weeks
Schmid et al., 2017	Case report	A severe flare of pouchitis in a patient diagnosed with pouchitis one year earlier	1	A total of three FMTs at baseline, after 5 and 9 weeks	Pouchoscopy	250 mL fecal-saline suspension	0/1 after 9 weeks	0/1 after 9 weeks	NA	NA	No reported adverse events.	9 weeks
Selvig et al., 2020	Cohort (prospective open-label pilot study)	Chronic pouchitis. Prior endoscopic evaluation confirming inflammation and over 4 weeks of symptoms	18 (7 of the 18 patients pre-treated with Rifaximin)	1 or 2 FMTs. Single or optional re-treatment	Pouchoscopy. Delivered to the most proximal point of insertion (proximal pouch or neo-terminal ileum)	250/500 mL in total derived from 25/50 g stool	1/11 after 4 weeks. Only 11 underwent pouchoscopy at 4 weeks	1/11 after 4 weeks	Mean ePDAI of 3.38 at baseline decreased to 3.36 after four weeks	Mean hPDAI of 1.05 at baseline increased to 1.36 after four weeks	One patient admitted to hospital 8 days after FMT because of abdominal pain considered not related to FMT. One patient diagnosed with Crohn’s disease at pouchoscopy after four weeks, which was suspected in advance. Minor self-limiting adverse events. Discomfort (4), flatulence (4), bloating or cramping (3), fatigue (3), and nausea (2).	12 months
Stallmach et al., 2016	Prospective open-label pilot study	Chronic antibiotics resistant pouchitis (three or more cycles of antibiotics)	5	1–7 FMTs	FMT to the jejunum with intervals of 3–4 weeks	275 mL fecal saline suspension derived from 75 g stool	5/5 after last FMT.	4/5 after last FMT	Mean ePDAI of 3.8 at baseline decreased to 1.2 after last FMT	Mean hPDAI of 3 at baseline decreased to 1.2 after last FMT	Mild transient fever and CRP increase in one patient.	3 months. One patient followed for 12 months
Steube et al., 2017	Prospective open-label pilot study	Chronic antibiotics resistant pouchitis	14	2–4 FMTs	Nasojejunal or capsule application delivered every 4 weeks according to treatment outcome	NA	7/14. PDAI scores however not described. Assessed through F-Calprotectin.	NA	NA	NA	No reported adverse events.	8 weeks

NA, not available; cPDAI, clinical Pouchitis Disease Activity Index; ePDAI, endoscopic Pouchitis Disease Activity Index; hPDAI, histologic Pouchitis Disease Activity Index; FMT, Fecal Microbiota Transplantation; RCT, Randomized Controlled Trial; mPDAI, modified Pouchitis Disease Activity Index; F-Calprotectin, Fecal Calprotectin.