Table 6.
Ongoing microbial-based and microbial-targeted clinical trials in IBD (Randomized trials)
| NCT number | Country | Start year |
Agent (s) | Target disease (s) |
Others | |
|---|---|---|---|---|---|---|
| Antibiotics | ||||||
| NCT00061282 | US | 2002 | Clotrimazole | Pouchitis | ||
| NCT00603616 | US | 2008 | Rifaximin | CD (active) | Induction of remission | |
| NCT01951326 | US | 2013 | Anti-Mycobacterium | CD (active) | Induction of remission | |
| NCT02033408 | Canada, Italy, Finland, Israel, Poland, Spain | 2014 | Antibiotics and FMT | UC, CD | ||
| NCT01783106 | UK | 2014 | Ciprofloxacin, Doxycycline, Hydroxychloroquine, Budesonide | CD | ||
| NCT02620007 | France | 2015 | Ciprofloxacin Rifaximin | CD (active) | Induction of remission AIEC targeted | |
| NCT03537157 | Italy | 2017 | Rifaximin | CD (post-ope) | ||
| NCT03476317 NCT02765256 |
US | 2018 | Vancomycin, Neomycin, Ciprofloxacin Polyethylene Glycol, Fluconazole | CD (refractory) | ||
| NCT03221166 | Italy | 2018 | Thalidomide, Infliximab | CD (new onset) | ||
| NCT04082559 | Israel | 2019 | Personalized antibiotics (Ciprofoxacin, Doxycycline) + diet (SCD, MSD) | Pouchitis, CD | ||
| NCT03794765 | India | 2019 | Adjuvant ceftriaxone, metronidazole | UC (active) | ||
| NCT03986996 | Israel | 2019 | Amoxicillin+Tetracycline+Metronidazole vs Amoxicillin+Tetracycline | UC | Induction of remission | |
| LBP (probiotics) | ||||||
| NCT03266484 | US | 2017 | Mixture (8 different bacterial strains) | CD, UC (inactive) | ||
| NCT03415711 | Italy | 2017 | VSL#3 | UC (active) | Induction of clinical and endoscopic remission | |
| NCT04102852 | Italy | 2019 | Lactobacillus rhamnosus GG | UC (active) | Induction of clinical remission | |
| Prebiotics | ||||||
| NCT02825914 | Denmark | 2016 | Casein glycomacropepptide | UC | ||
| NCT03500653 | Israel | 2018 | Curcumin | IBD | ||
| NCT03653481 | US | 2018 | Oligofructoseenriched Inulin | IBD | ||
| NCT03847467 | US | 2019 | Fucosyllactose | CD, UC (child, adult) | Patients receiving stable maintenance anti-TNF therapy | |
| NCT03998488 | US | 2019 | FMT + Psyllium | UC (active) | ||
| NCT02277223 | Israel | 2019 | Curcumin | UC (pediatric) | ||
| NCT02683759 | India | 2019 | Curcumin | UC | ||
| Diet | ||||||
| NCT04046913 | UK | 2013 | Low additive diet | CD | ||
| NCT02472457 | US | 2015 | Crohn’s Disease Exclusion Diet | CD | ||
| NCT02796339 | Greece | 2016 | Mastiha (Pistacia lentiscus) | IBD | ||
| NCT02734589 | France, Israel, Italy | 2017 | Novel diet for the donor + FMT | UC | ||
| NCT03000101 | Italy | 2017 | Pomegranate | CD, UC | Protocol in PMID 31171016 | |
| NCT03012542 | US | 2017 | carbohydrates- or fiber- controled diet | CD | ||
| NCT03053713 | Canada | 2017 | MSD | UC | ||
| NCT03058679 | US | 2017 | MSD, SCD | CD | ||
| NCT03301311 | US | 2018 | SCD, modified SCD | CD, UC (inactive) | ||
| NCT02843100 | Canada, Ireland, Israel, Spain | 2018 | Modified Exclusive Enteral Nutrition, Crohn’s Disease Exclusion Diet, Partial Enteral Nutrition, Standard Exclusive Enteral Nutrition | CD | ||
| NCT04143633 | Mexico | 2018 | Low FOMAP diet | UC | ||
| NCT02201758 | Canada | 2018 | Flaxseed lignanenriched complex | UC | ||
| NCT04147585 | US | 2019 | Intermittent reduced calorie diet | CD | ||
| NCT03615690 | US | 2019 | Fasting mimicking diet | UC | ||
| NCT04082559 | Israel | 2019 | Personalized antibiotics (Ciprofoxacin, Doxycycline) + diet (SCD, MSD) | Pouchitis | ||
| NCT03850600 | US | 2019 | Diet intervention (no details) | CD (pregnancy) | ||
| NCT04014517 | Italy | 2019 | Nestle IMPACT | CD | Prevention of reccurence after surgery | |
| NCT03980405 | Israel | 2019 | Ulcerative collitis diet | UC | Adjuvant to 5-ASA | |
| NCT04018040 | Australia | 2019 | Lacto-ovo vegetarian diet | UC | ||
| Synbiotics | ||||||
| NCT02865707 | Canada | 2016 | Synergy-1 | UC | Prevention of relapse | |
| FMT | ||||||
| NCT01790061 | China | 2012 | Standardized FMT vs traditional FMT | UC | ||
| NCT02636517 | US | 2015 | FMT | CD, UC | ||
| NCT02390726 | US | 2015 | FMT | UC (active) | ||
| NCT03561532 | Finland | 2016 | FMT | UC | ||
| NCT02291523 | US | 2016 | FMT | UC (pediatric) | ||
| NCT02606032 | Canada | 2016 | 4 arms of pre-antibiotics + FMT | UC (active) | ||
| NCT03078803 | Canada | 2017 | FMT via colonoscope or oral FMT | CD | ||
| NCT03110289 | Belgium | 2017 | FMT superdonor vs FMT autologous | UC | Superdonor is based on abundance of taxa of the investigators’ interest | |
| NCT03273465 | Israel | 2017 | FMT | UC (active) | ||
| NCT03104036 | Czechia | 2017 | FMT vs 5-ASA enema | UC (active) | ||
| NCT03006809 | US | 2017 | +/−Pre-Ax + low/high FMT | UC (active) | ||
| NCT03378167 | Canada | 2018 | FMT oral | CD (pediatric) | ||
| NCT03582969 | Israel | 2018 | FMT | UC (pediatric) | ||
| NCT03378921 | Finland | 2018 | FMT | UC, Pouchitis | ||
| NCT03716388 | India | 2018 | FMT vs FMT+5-ASA vs 5-ASA | UC (active) | ||
| NCT04100291 | Denmark | 2019 | FMT | UC, Pouchitis | ||
| NCT03843385 | Germany | 2019 | FMT-filtrated vs FMT vs Plaebo | UC | ||
| NCT03829475 | US | 2019 | FMT | +/− Bezlotoxumab | IBD | |
| NCT03998488 | US | 2019 | FMT+Psyllium | UC (active) | ||
| NCT03483246 | France | 2019 | FMT | UC | ||
| NCT03747718 | US | 2019 | FMT single vs maintainance | CD | ||
| NCT04034758 | China | 2019 | Heterologous FMT | UC (active, adult, older adult) | ||
| NCT03804931 | China | 2019 | 5-ASA/steroid +/− FMT | UC | ||
| NCT03948919 | US | 2019 | Low sulfur FMT | UC (active) | ||
| NCT03917095 | China | 2019 | Colonic transendoscopic enteral tubing | UC (active) | ||
| Bacteriophage | ||||||
| NCT03808103 | US | 2019 | EcoActive | CD | ||
Information from ClinicalTrials.gov., IBD: inflammatory bowel disease, CD: Crohn’s disease, UC: ulcerative colitis, FMT: fecal microbiota transplant, 5-ASA: 5-aminosalicylic acid, PMID: PubMed identifier, SCD: specific carbohydrate diet, MSD: mediterranean style diet, FOMAP:low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol , AIEC: adherent-invasive Escherichia coli