Table 1.
Characteristics of RCTs of FMT vs placebo in IBS
| Study, year | Study population | Setting | Study site | Sample size | IBS criteria | IBS subtypes | Primary outcome |
|---|---|---|---|---|---|---|---|
| Johnsen et al., 2017 (19) | Single center | Primary care | Norway | 90 | Rome III | IBS-D 53% IBS-M 47% |
Decrease in IBS-SSS > 75 points at 3 mo |
| Holvoet et al., 2018 (20) | Single center | Tertiary care | Belgium | 64 | Rome III | Predominant bloating and non-C | Yes to question of improvement in overall symptoms and abdominal bloating at 12 wk |
| Aroniadis et al., 2018 (22) | Multi-center | Primary, secondary, and tertiary care | USA | 48 | Rome III | IBS-D | Decrease in IBS-SSS ≥ 50 points at 12 wk |
| Halkjaer et al., 2018 and Aroniadis et al., 2018 (21,22) | Two centers | Tertiary care | Denmark | 52 | Rome III | All subtypes 33.3% IBS-C 29.4% IBS-D 37.3% IBS-M |
Decrease in IBS-SSS ≥ 50 points at 3 mo |
| Study, Year | Secondary outcomes | Fecal microbiota preparation | Placebo | FMT route | Frequency and duration | Follow-up |
|---|---|---|---|---|---|---|
| Johnsen et al., 2017(19) | Decrease in IBS-SSS > 75 points at 12 mo | 50–80 g pooled donor feces (2 donors) mixed with 200 mL isotonic saline and 50 mL 85% glycerol | Patients’ own feces | Colonoscopy | Once | 12 mo |
| Holvoet et al., 2018(20) | Change in IBS symptom scores by using daily diary, IBS-QOL, microbiota composition | Feces from 2 healthy donors | Patients’ own feces | Nasojejunal tube | Once | 12 mo |
| Aroniadis, 2018(22) | IBS-QOL, HADS, Bristol stool scale scores, microbiome profiles, AEs | 75 FMT capsules containing 50 g feces from 1 of 4 donors | Placebo capsules not containing fecal microbiota | Water soluble gelatin oral capsules | 25 capsules daily × 3 d | 24 wk |
| Halkjaer, 2018(21) | Change in IBS-QOL at 3 mo, changes in microbiota diversity | 300 FMT capsules containing 144 g fecal matter derived from 600 g pooled donor feces (4 donors) | Placebo capsules not containing fecal microbiota | Acid-resistant oral capsules (capsugel DRcaps) | 25 capsules daily × 12 d | 6 mo |
AE, adverse event; FMT, fecal microbiota transplantation; HADS, Hospital Anxiety and Depression Scale; IBS, irritable bowel syndrome; IBS-C, -D, -M, non-C, IBS with predominant constipation, predominant diarrhea, predominant irregular bowel habits (mixed diarrhea/constipation), non-constipation; IBS-SSS, IBS Severity Scoring System; IBS-QOL, Irritable Bowel Syndrome-Quality of Life Measure; RCT, randomized controlled trial.