Table 2.
Approved clinical trials explore the effects of short-chain fatty acids on the treatment and prognosis of patients with colorectal cancer (Data sources: ClinicalTrials).
| Identifier | Launch date | Conditions | Gender | Age | Study Title | Interventions | Treatment duration phase | Study design | Measures | Outcomes |
|---|---|---|---|---|---|---|---|---|---|---|
| NCT04211766 | 2021.01 | Healthy subject | M/F | 50 years to 75 years | Fiber and fish oil supplements for the prevention of colorectal cancer | Dietary supplement: dietary fiber; Dietary supplement: fish oil Other: placebo; |
Phase 1 | Allocation: randomized; Intervention model: crossover assignment; Masking: double (participant, investigator); Primary purpose: prevention; |
Change in mRNA expression profiles in the exfoliome at baseline to 2 years | Completed No results posted |
| NCT03781778 | 2019.05 | Colon cancer; Rectal cancer; Survivor; |
M/F | 18 years and older | Pilot trial of resistant starch in stage I-III olorectal cancer survivors | Other: dietary intervention (resistant starch); Other: dietary intervention (regular starch); Other: questionnaire administration; |
Phase 2 | Allocation: randomized; Intervention model: parallel assignment; Masking: double (participant, investigator); Primary purpose: prevention; |
Variability of biomarkers of insulin resistance and inflammation (adiponectin) at baseline and 8 weeks; Variability in biomarkers of insulin resistance and inflammation (CRP) at baseline and 8 weeks; Variability in gut microbial communities from human stool samples at 2 and 8 weeks; Fecal microbiota from resistant starch responders at 2 and 8 week;s |
Completed The variation of adiponectin and CRP and the diversity of gut microbiota are low in resistant starch group |
| NCT03028831 | 2017.12 | Colon cancer | M/F | 40 years to 70 years | Fiber to reduce colon cancer in Alaska native people | Dietary supplement: 70g of fully digestible starch amylopectin corn starch; Dietary supplement: resistant starch; |
Not applicable | Allocation: randomized; Intervention model: parallel assignment; Masking: quadruple (participant, care provider, investigator, outcomes assessor); Primary purpose: prevention; |
Colonic mucosal proliferation at 4 weeks; Colonic microbiota at 4 weeks; Colonic secondary bile acids at 4 weeks; |
Recruiting |
| NCT03531606 | 2016.12 | Sigmoid colon cancer | M/F | 20 years to 75 years | The effects of Mechnikov probiotics on symptom and surgical outcome | Drug: mechnicov probiotics; Drug: placebo; |
Not applicable | Allocation: randomized; Intervention model: parallel assignment; Masking: single (care provider); Primary purpose: treatment; |
Anterior resection syndrome improvement change at 1, 4, 5 weeks after surgery; Bowel examination at 4, 5 weeks after surgery; Quality of life of cancer patients (EORTC QLQ-C30) at 1 week before surgery and 4 weeks after surgery; Markers related inflammation at 1 week before surgery and 4 weeks after surgery; NSI at 1 week before surgery and 1.5, 4 weeks after surgery; Clavien-Dindo classification at 1 week before surgery and 1.5, 4 weeks after surgery; NGS, short chain fatty acids at 1 week before surgery and 1, 4, 5 weeks after surgery; |
Completed No results posted |
| NCT02699047 | 2015.03 | Gastrointestinal cancer; Colorectal cancer; Stomach cancer; |
M/F | 40 years to 79 years | Fish oil supplementation in gastrointestinal cancer | Dietary supplement: encapsuled fish oil; Dietary supplement: encapsulated olive oil; |
Not applicable | Allocation: randomized; Intervention model: parallel assignment; Masking: quadruple (participant, care provider, investigator, outcomes assessor); Primary purpose: treatment; |
Change in quality of life at baseline and 9 weeks (final moment); Cytokines of inflammatory response at baseline, 5 and 9 weeks; Body weight at 5 and 9 weeks; Body mass index at baseline, 5 and 9 weeks; Weight change at baseline, 5 and 9 weeks; Fat mass at baseline and 9 weeks; Lean body mass at baseline and 9 weeks arm circumference at baseline, 5 and 9 weeks; Tricipital skinfold at baseline, 5 and 9 weeks; Serum C-reactive protein at baseline, 5 and 9 weeks; Activity of catalase at baseline and 9 weeks; Activity of glutathione peroxidase at baseline and 9 weeks; Activity of superoxide dismutase at baseline and 9 weeks; Lipid peroxidation at baseline and 9 weeks; Evaluation of adverse events consequences at baseline and 9 weeks; Graduation of adverse events at baseline, 5 and 9 weeks; Tumor markers at baseline and 9 weeks; Survival at baseline, 6 months and one year; Serum albumin at baseline, 5 and 9 weeks; |
Unknown |
| NCT01661764 | 2013.02 | Colorectal adenomatous polyps | M/F | 40 years to 79 years | Fish oil supplementation, nutrigenomics and colorectal cancer prevention | Drug: eicosapentanoic acid and docosahexanoic acid; Drug: oleic acid; Other: placebo; |
Phase 2 | Allocation: randomized; Intervention model: factorial assignment; Masking: quadruple (participant, care provider, investigator, outcomes assessor); Primary purpose: prevention; |
Rectal epithelial ecll proliferation at 6 month; Rectal epithelial cell apoptosis at 6 months; |
Completed The results have shown no statistical significance |
| NCT01575340 | 2011.07 | Colorectal cancer | M/F | 19 years and older | Study to assess the effect of consumption of fish oil Encapsulated on inflammatory markers in colorectal cancer | Dietary supplement: fish oil encapsuled | Not applicable | Allocation: randomized; Intervention model: parallel assignment; Masking: none (open label); Primary purpose: supportive care; |
Change in inflammatory markers at two months; Change in body composition at two months; Change in nutritional status at two months; Changes in cellular lipid profile at two months; |
Completed No results posted |
| NCT01479907 | 2010.11 | Colorectal neoplasms | M/F | 18 years to 80 years | Synbiotics and gastrointestinal function related quality of life after colectomy for cancer | Dietary supplement: synbiotics; Dietary supplement: placebo; |
Not applicable | Allocation: randomized; Intervention model: single group assignment; Masking: quadruple (participant, care provider, investigator, outcomes assessor); Primary purpose: supportive care; |
Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively | Completed No results posted |
| NCT03072641 | 2010.06 | Colon cancer | M/F | 18 years and older | Using probiotics to reactivate tumor suppressor genes in colon cancer | Dietary supplement: ProBion Clinica | Not applicable | Allocation: randomized; Intervention model: parallel assignment; Masking: none (open label); Primary purpose: basic science; |
Changes in microbiota composition at baseline and after probiotics use; Epigenetic changes at baseline and after probiotics use; |
Completed No results posted |
| NCT01609660 | 2010.03 | Colorectal cancer | M/F | 18 years and older | Impact of probiotics on the intestinal microbiota | Dietary supplement: Saccharomyces boulardii | Phase 4 | Allocation: randomized; Intervention model: parallel assignment; Masking: none (open label); Primary purpose: prevention; |
Mucosal cytokine; Short chain fatty acids; |
Completed No results posted |
| NCT03420443 | 2008.11 | Rectal cancer | M/F | 18 years to 80 years | Action of synbiotics on irradiated GI mucosa in rectal cancer treatment | Dietary supplement: oat bran; Dietary supplement: oat bran and blueberry husks; Dietary supplement: no oral supplementation; |
Not applicable | Allocation: randomized; Intervention model: parallel assignment; Masking: triple (participant, investigator, outcomes assessor); Primary purpose: prevention; |
Action of synbiotics on irradiated gastrointestinal mucosa in rectal cancer treatment at 2 weeks | Completed No results posted |
| NCT00335504 | 2006.03 | Colon cancer Rectal cancer |
M/F | 40 years and older | Atorvastatin calcium, oligofructose-enriched inulin, or sulindac in preventing cancer in patients at increased risk of developing colorectal neoplasia | Drug: oligofructose-enriched inulin; Drug: sulindac; Drug: placebo; Drug: atorvastatin calcium; Other: laboratory biomarker analysis; |
Phase 2 | Allocation: randomized; Intervention model: parallel assignment; Masking: double (participant, investigator); Primary purpose: prevention; |
Percent change in number of rectal aberrant cryptic foci as measured by magnification chromoendoscopy at 6 months; Effects on proliferation (Ki67 expression) at 6 months; Effects on apoptosis (caspase-3 expression) at 6 months; Adverse events at 6 months; |
Completed The results have shown no statistical significance |
M, male; F, female; AJCC, American Joint Committee on Cancer; CRP, C-reactive protein; EORTC QLQ-C30, The European Organisation for Research and Treatment of Cancer core questionnaire-C30; NSI, Nutritional Screening Index; NGS, next-generation sequencing.