Table 3.
Clinical trials involving purified metabolites, postbiotic derivates, and prebiotics for postbiotic measurable production.
| Intervention | Type of Study | Type of Cancer | Median Age (IQR) |
Sample Size (n. Events) |
Median Follow Up |
Antitumoral Benefit | |
|---|---|---|---|---|---|---|---|
| Boutron-Ruault MC et al., 2005 [100] |
Supplementation with s-FOS | Interventional prospective study | - Small adenomas - Large adenomas - Healthy controls |
61 (8) | 74 | - | Higher fecal butyrate concentration in the adenoma group after the 3-month administration of sc-FOS |
| Chen HM et al., 2013 [99] | None | Cross-sectional observational study | Patients with a resected AP vs. healthy controls |
58 (11) | 391 | - | Lower SCFA levels were found in the AP group Clostridium, Roseburia and Eubacterium spp were retrieved at higher levels in the healthy controls Enterococcus and Streptococcus spp. were more highly represented in the AP group |
| Motoori M et al., 2017 [107] |
Synbiotic supplementation 10 days after chemotherapy | Phase II, randomized open-label study | Esophageal cancer | - | 61 | - | Decrease in toxicity incidence (nausea, diarrea and febrile neutropenia) |
| Hoyt M et al., 2019 [93] | Menokinones, phylloquinone | post hoc Observational study | Prostate cancer | 63 (6) | 28,356 (2978) |
11.3 months | No benefits as risk-reducing factor |
| Niccolai E et al., 2019 [96] | None | Cross-sectional, controlled, nonrandomized, observational study | Colorectal cancer vs. AP and healthy controls |
CRC: 80 (13) AP: 46 (8) |
60 | - | CRC patients showed increased levels of butyric isobutyric, valeric and isovaleric acid, whereas the levels of acetic acid were reduced |
| Xie X et al., 2019 [106] |
Supplementation with 30 mg/d of prebiotics (fiber) aiming to raise intestinal SCFAs | Interventional prospective study | Colon cancer development | 60 (9) | 135 | - | Preoperative period: higher levels of IgM, IgG and transferrin Postoperative period: higher levels of IgA, IgG, CD8+ Cells, B-cell lymphocytes |
| Ocvirk. S et al., 2020 [98] | None | Cross-sectional observation study | Apparently healthy patients | 51 (8) | 53 (AN: 32 RA: 21) |
- | AN ate more fatty and caloric food than RA In AN, 16 out of 32 patients had colic adenomatous polypolsis, whereas none of RA developed polyposis. Stools from RA were more enriched by SCFAs than AN stools. |
| Haruna Y et al., 2021 [94] | Vitamin K + sorafenib vs. sorafenib alone |
Phase 2, randomized, open-label study | Hepatocarcinoma | 72 (8) | 44 (44) |
70 months | Benefit for ORR (27.3% vs. 4.5%, p = 0.039) PFS (HR = 0.59, p = 0.12) No benefit for OS (HR = 0.59, p = 0.12) |
| Seethaler B et al., 2022 [95] |
Increase in SCFA production through diet and physical activity | Phase 2, randomized, controlled, open label study | BRCA-mutated patients | 44 (2) | 260 women | - | Increase in level of fecal SCFAs produced Decrease in intestinal permeability mediated by SCFAs |
| Motoori M et al., 2017 [111] |
Synbiotic supplementation in addition to enteral nutrition and prophylactic antibiotics during neoadjuvant chemotherapy | Phase II, randomized open-label multicenter study | Esophageal cancer | - | 81 | - | Signficiant decrease in grade 3 and grade 4 toxicity incidence (nausea, diarrea and neutropenia) but not febriel neutropenia (p = 0.088) |
| Liu L et al., 2023 [103] |
Supplementation with either 50 or 100 mg/d of Riboflavin for 2 weeks | Interventional prospective study | Colon cancer development | 31 (11) | 105 | 28 days | Higher fecal butyrate level with riboflavin supplemantetion regardless of the given dose |
AN: Alaska-native patients, AP: adenomatous polyp, RA: rural African patients, s-FOS: short-chain fructo-oligosaccharides.