Copyright ©The Author(s) 2016.
World J Gastroenterol. Dec 21, 2016; 22(47): 10304-10315
Published online Dec 21, 2016. doi: 10.3748/wjg.v22.i47.10304
Table 1 Rates of clinical response after fecal microbial transplant for recurrent Clostridium difficile infection by fecal microbial transplant method
FMT methodResolution of symptomsStudies/total patients analyzed
Upper gastrointestinal tract (Nasogastric/nasoduodenal/nasojejunal) tube77%7/187
Upper gastrointestinal tract + colonoscopy100%1/27
Table 2 Published pediatric fecal microbial transplant studies for recurrent Clostridium difficile infection
RefAGE (yr)nFMT routeResponse rate
Hourigan et al[22], 20156-178Colonoscopy100%
Kronman et al[55], 20156-1710NG90%
Wang et al[58], 201511NJ100%
Kelly et al[10], 20146-165Not specified89% (whole series)
Pierog et al[56], 20141-216Colonoscopy100%
Russell et al[57], 20141-2110NG (2); Colonoscopy (8)90%
Walia et al[59], 20141-22Colonoscopy100%
Rubin et al[60], 20136-82NG (64); EGD (7); Gastrostomy (previously placed) (4)50%
Kahn et al[44], 201211Colonoscopy100%
Table 3 Rates of resolution of recurrent Clostridium difficile infection using fresh vs frozen fecal microbial transplant
Ref.Fresh, nFrozen, nFresh FMT resolution rateFrozen/prepared FMT resolution rate
Hamilton et al[28], 2012122119/2111/12
Petrof et al[29], 201312N/A100%
Lee et al[27], 201687 (PP)91 (PP)74/87, 85.1% (PP)76/91, 83.5% (PP)
111 (mITT)108 (mITT)78/111, 70.3% (mITT)81/108, 75.0% (mITT)
Table 4 Published pediatric fecal microbial transplant case series for inflammatory bowel disease
Ref.AGE (yr)Diagnosis, nFMT protocolClinical response criteriaResponse rate (%)
Kunde et al[32], 20137-219, UCSerial enemas for 5 dDecrease in PUCAI by > 15 points after FMT7/9 clinical response at 1 wk (78)
6/9 maintained response at 4 wk (67)
Kellermayer et al[33], 201514-163, UCSerial enemas and colonoscopy over 6-12 wkPUCAI < 353/3 endoscopic remission at 2 wk (100)
3/3 histologic remission at 2 wk (100)
3/3 clinical response at 4 wk (100)
3/3 withdrawal of all immunotherapy at 15 wk (100)
Suskind et al[34], 201512-199, CDSingle FMTPCDAI < 107/9 clinical response at 2 wk (78)
via NGT5/9 maintained response at 6, and 12 wk (56)
Suskind et al[35], 201513-164, UCSingle FMTPUCAI < 10No clinical response (0)
via NGTNo laboratory benefit
Table 5 Study characteristics and outcomes of published adult cohort studies of fecal microbial transplant for inflammatory bowel disease
Ref.Clinical outcomeFollow-up
Wang et al[62], 2014Clinical remission (1/2: 1 mo, 3 mo);3 mo
Clinical response (2/2: 1 wk)
Kump et al[49], 2013Clinical remission (0/6: 90 d);3 mo
Clinical response (6/6: 2 wk; 4/6: stool frequency increased: 30 d; 2/6 sustained improvement: 90 d);
Total colectomy (1/6), total proctocolectomy (2/6)
Wei et al[63], 2015Mayo score: decreased from 5.80 ± 1.87 to 1.50 ± 1.35 (P < 0.01)1 mo
Angelberger et al[26], 2013Clinical remission (0/5: 12 wk);3 mo
Clinical response (1/5: 12 wk);
Further deterioration (2/5: 4 wk)
Scaldaferri et al[64], 2015Clinical remission (2/8: 2 wk; 2/8: 6 wk; 3/8: 12 wk);3 mo
Clinical response (2/8: 2 wk; 4/8: 6 wk; 4/8: 12 wk);
Endoscopic response (2/6)
Ren et al[65], 2015Mayo score: 11 patients achieved reduction of score1-7 mo
Cui et al[50], 2015Clinical improvement and steroid-free remission: 8/14;3-18 mo
Long-term remission: 4/14
Damman et al[66], 2015Clinical remission (1/6: 4 wk; 0/6: 3 mo);Not reported
Worsening symptoms (6/6: 3 mo);
Histology score improvement (5/6: 4 wk)
Borody et al[23], 2012Complete clinical remission: 42/62;3 mo
Partial response: 15/62; Failure: 5/62;
Normalization of mucosa: 8/21
Kump et al[49], 2013Mayo score decrease > 3 points (5/9: 90 d);1 mo
Sustained mucosal healing: 1/9;
Failure to sustain clinical improvement: 4/9
Landy et al[67], 2013Clinical remission: 0/8;1 mo
Improvement in Cleveland Global Quality of Life score: 0/8
Table 6 Study characteristics and outcomes of published randomized controlled trials of fecal microbial transplant for inflammatory bowel disease
GroupMoayyedi et al (2015)Rossen et al (2015)
n (active/placebo)75 (38/37)48 (23/25)
PopulationAdult patients; Mild-moderate UCAdult patients; Mild-moderate UC
Active arm50 mL enema (8 g healthy donor stool)500 mL nasoduodenal infusion (120 g healthy donor stool)
Administered weekly × 6 wkAdministered at week 0, 3
Control armNormal salineAutologous FMT (patient’s stool)
Inclusion of patients on BiologicsYes, stable doses ≥ 12 wkNo
Primary outcomeClinical remission (partial Mayo endoscopic score < 3 and Mayo endo score = 0) at week 7Remission (SCCAI ≤ 2 + ≥ 1pt reduction in Mayo endoscopic score) at week 12
Clinical response (reduction in full Mayo score ≥ 3)
Results9/38 (24%) treated with FMT vs 2/37 (5%) controls (P = 0.03)7/23 (30%) treated with FMT vs 5/25 (20%) controls (P = 0.51)
Table 7 Clinical trials of fecal microbial transplant for pediatric inflammatory bowel disease (registered through
LocationTrial numberDiagnosisAge (yr)DonorFMT routeInterven-tionProtocol
Hamilton,NCT02487238UC6-17AnonymousEnemaFMT, SalineRetention enema; 2 × weekly × 6 wk; 33-wk follow up
CanadaRandomized Single Blinded
California, United StatesNCT02291523UC7-2Accepting volunteersColonoscopicFMT, SalinePatients on high-dose 5-ASA; 1 × colonoscopic administration; 12-mo follow up
Randomized Double Blinded
Chongqing, ChinaNCT02335281UC/CD16-70Not specifiedNasojejunalFMT, MesalazineSingle nasojejunal administration; 1-yr follow up
Randomized Single Blinded
Texas, United StatesNCT01947101UC12-20AnonymousColonoscopic /EnemaFMTColonoscopic administration for first treatment; subsequent periodic treatments over 1-year with enema administration
Pennsylvania, United StatesNCT02108821UC/CD2-22Family memberColonoscopicOpen LabelFresh stool sample; 1 ×, 1-h duration; 6-mo follow up
Michigan, United StatesNCT01560819UC/CD7-21Family memberEnemaOpen Label1-hour retention enema; daily × 5 d; 6-mo follow up
Jerusalem, Israel;NCT02033408UC/CD2-75Not specifiedNot specifiedOpen LabelSecondary treatment for antibiotic, corticosteroid failures; 3-yr follow up
Toronto, Canada;FMT
Helsinki, Finland;Open Label
Napoli, Italy;
Rome, Italy;
Krakow, Poland;
Malaga, Spain
Michigan, United StatesNCT01560819UC/CD7-21Family member/EnemaFMTRetention enema; Administered daily × 5 d; 6-mo follow up
Chosen by familyOpen Label
Turku, FinlandNCT01961492UC1-75AnonymousColonoscopicFMTSingle colonoscopic administration; 1-yr follow up
Open Label
Jiangsu, ChinaNCT01793831UC/CD10-70Not specifiedNasogastricFMTSingle nasogastric administration; 12-mo follow up
Shaanxi, ChinaOpen Label
Jiangsu, ChinaNCT01790061UC10-70Not specifiedDuodenal (gastroscopic)FMT1-mo follow up
Shaanxi, ChinaOpen LabelFresh, or frozen FMT administered via gastroscope
No prior biologic, immunomodulatory, corticosteroid therapy
Jiangsu, ChinaNCT02560727UC10-70Not specifiedColonoscopicNot specified12-mo follow up
No prior biologic, immunomodulatory, corticosteroid therapy