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©The Author(s) 2023.
World J Gastroenterol. May 28, 2023; 29(20): 3185-3202
Published online May 28, 2023. doi: 10.3748/wjg.v29.i20.3185
Published online May 28, 2023. doi: 10.3748/wjg.v29.i20.3185
Table 1 Characteristics of randomised controlled trials of faecal microbiota transplantation for treating irritable bowel syndrome
Ref. | Trial design | Country | Sample size | IBS subtypes | Inclusion criteria | Frequency and route of administration | FMT-content | Placebo content | Pretreatment | Number of donors |
Aroniadis et al[59], 2019 | RCT, crossover | United States | 48 (25 FMT vs 23 placebo) | IBS-D | Moderate-to-severe IBS symptoms (IBS-SSS > 175) | 3 d of 25 oral capsules | 3 × 25 frozen capsules (0.38 g donor stool/capsule) (Openbiome) | Non-toxic brown pigment | PPI for three days | One donor for one patient (four different donors) |
El-Salhy et al[60], 2020 | RCT, 3 parallel groups | Norway | 164 (54/30 gram FMT, 55/60 gram FMT, 55 placebo) | All subtypes | Moderate-to-severe IBS symptoms (IBS-SSS > 175) | Single treatment via gastroscope to distal duodenum | Once 30 g or 60 gram of frozen feces in sterile saline solution | Autologous faeces | None | One donor |
Halkjær et al[43], 2018 | RCT, 2 parallel groups | Denmark | 51 (25 FMT, 26 placebo) | All subtypes | Moderate-to-severe IBS symptoms (IBS-SSS > 175) | 12 d of 25 oral capsules | 25 FMT capsules (one daily dose containing approximately 12 g frozen faecal material) | Saline, glycerol and food colouring E150 | Bowel cleansing | Donor mix from four donors |
Holster et al[61], 2019 | RCT, 2 parallel groups | Sweden | 16 (8 FMT, 8 placebo) | All subtypes | IBS with small amounts of butyrate-producing bacteria | Single treatment via colonoscopy to the caecum | 30 g frozen stool in sterile saline and glycerol | Autologous feces | Bowel cleansing and 4 mg loperamide | Two donors (three patients received stool from donor 1, the remaining five from donor 2) |
Holvoet et al[44], 2021 | RCT, 2 parallel groups | Belgium | 62 (43 FMT, 19 placebo) | IBS-D and IBS-M | Refractory IBS with failure of at least three conventional IBS therapies | Single treatment via nasojejunal administration | Fresh feces mixed with saline | Autologous feces | Bowel cleansing | Two donors |
Johnsen et al[62], 2018 | RCT, 3 parallel groups | Norway | 83 (26 fresh FMT, 29 frozen FMT, 28 placebo) | IBS-D and IBS-M | Moderate-to-severe IBS symptoms (IBS-SSS > 175) | Single treatment administered into the caecum via colonoscopy | 50–80 g fresh or frozen feces mixed with saline and glycerol | Autologous feces | Bowel cleansing and 8 mg loperamid | Donor mix from two donors |
Lahtinen et al[58], 2020 | RCT, 2 parallel groups | Finland | 51 (25 FMT, 26 placebo) | IBS-D, IBS-M and IBS-U | Patients who remained symptomatic despite receiving conventional treatment | Single treatment administered into the caecum via colonoscopy | 30 g frozen suspension | Autologous feces | Bowel cleansing | One donor |
Singh et al[63], 2022 | RCT, 4 parallel groups | United States | 23 (11 FMT, 12 placebo) | IBS-D | IBS-SSS > 150 or > 175 | Single treatment with 19 oral capsules | Capsule contain 0.75 frozen fecal filtrate) (Openbiome) | Glycerol with brown coloring agent | Bowel cleansing | Six donors (unknown if donors were mixed) |
Table 2 Summarised findings for comparing fecal microbiota transplantation with placebo for the treatment of irritable bowel syndrome
Outcomes and timeframe | Anticipated absolute effects | Relative effect (95%CI) | Number of participants (trials) | Certainty of the evidence (GRADE) | Comments | |
Effect in placebo | Effect difference with FMT (95%CI) | |||||
Improvement of symptoms after three months | 42 per 100 | 8 or more per 100 (from 13 or fewer to 46 or more) | RR 1.19 (0.68-2.10) | 484 (8 RCTs) | ++--1 Low | Improvement of symptoms as measured by a validated global IBS symptoms score (e.g., IBS-SSS scale from 0, no symptoms, to 500, maximum symptoms) (as defined by each trial) |
Improvement of symptoms after six months | 38 per 100 | 5 or fewer per 100 (from 25 or fewer to 52 or more) | RR 0.88 (0.33-2.39) | 99 (3 RCTs) | ++--2 Low | Improvement of symptoms as measured by a validated global IBS symptoms score (e.g., IBS-SSS scale from 0, no symptoms, to 500, maximum symptoms) (as defined by each trial) |
Adverse events prior to end of trial | 26 per 100 | 4 or more per 100 (from 10 or fewer to 30 or more) | RR 1.17 (0.63-2.15) | 450 (7 RCTs) | ++--3 Low | Common adverse events were mild and self-limiting gastrointestinal symptoms |
Serious adverse events prior to end of trial | 1 per 100 | 1 or fewer per 100 (from 1 or fewer to 2 or more) | RR 0.42 (0.07-2.60) | 501 (8 RCTs) | ++--4 Low | Serious adverse events included one suicide (placebo), cholecystitis (placebo), and one admission to the hospital due to discomfort after the FMT procedure |
Dropouts due to adverse events prior to end of trial | 1 per 100 | 1 or fewer per 100 (from 1 or fewer to 1 or more) | RR 0.24 (0.03-2.17) | 502 (8 RCTs) | ++--5 Low | Dropouts due to adverse events include one suicide (placebo) and one for discomfort after the FMT procedure (placebo) |
Improvement in QoL scores after three months | NA | NA | MD -6.30 (-13.39 to 0.79) | 406 (7 RCTs) | ++--6 Low | Improvement of quality of life as measured by a validated scale IBS-QoL, where 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for interpretation (high scores indicate better IBS-QoL) |
- Citation: Halkjær SI, Lo B, Cold F, Højer Christensen A, Holster S, König J, Brummer RJ, Aroniadis OC, Lahtinen P, Holvoet T, Gluud LL, Petersen AM. Fecal microbiota transplantation for the treatment of irritable bowel syndrome: A systematic review and meta-analysis. World J Gastroenterol 2023; 29(20): 3185-3202
- URL: https://www.wjgnet.com/1007-9327/full/v29/i20/3185.htm
- DOI: https://dx.doi.org/10.3748/wjg.v29.i20.3185