Colorectal CancerNCT04821258
Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery for Colorectal Cancer
A study testing MICODIGEST 2.0 supplement in people with Colorectal Cancer and Surgery--Complications, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
Trial summary
Most of Colorectal cancer (CRC) diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used prior to the admission for the prevention of postoperative complications. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Surgery--Complications
- What is being tested?
- MICODIGEST 2.0 supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jun 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CRC patients who are candidates for surgical treatment with curative intent (risk I-III).
- American Society of Anesthesiologists' Physical Status Classification (ASA) <3.
- Patients aged between 18 and 85 years.
- Eastern Cooperative Oncology Group (ECOG) scale between 0-2.
- Patients with preserved cognitive function.
- Patient's authorization after reading the study information sheet.
Who cannot join
- Candidates for neoadjuvant therapy.
- Patients with concomitant carcinoma.
- Allergy to the supplied nutraceutical or presence of malabsorption syndrome.
- Presence of mental disorders
- Patient with active infection or antibiotic therapy in the last month.
- Previous colorectal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Randomized Clinical Trial to Evaluate the Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery With Curative Intent for Colorectal Cancer
Most of Colorectal cancer (CRC) diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used prior to the admission for the prevention of postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in CRC patients after surgery.
It seems the combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Therefore, the fungal extract nutraceutical MICODIGEST 2.0 could be used to reduced the complications after CRC surgery.
Based on this hypothesis, we have designed a double-bind randomized clinical trial to evaluate the effect of MICODIGEST 2.0 on the complications after surgery with curative intent for CRC.
Read the detailed description
Colorectal cancer (CRC) is one of the most common malignancies in western countries. Most of the CRC diagnosed are candidates for surgical resection with curative intent. Cure rates after surgery vary between 92 % and 67 % depending on the tumor stage. However, colorectal surgery is associated with some complications that could be life-threatening.
Antibiotic prophylaxis is commonly used prior to the admission for the prevention of this postoperative complications. Several studies have shown that antibiotic administration reduces the risk of infections associated with surgery. Nevertheless, this intervention does not modify the mortality and severity of other complications detected. Further, antibiotic prophylaxis could change the intestinal microbiota and promote adverse inflammatory outcomes in CRC patients after surgery.
Fungal polysaccharides have attracted attention because of their role in gut microbiota modulation. It seems that this type of polysaccharides could reduce pathogen levels and stimulate the growth of beneficial microorganism. Anti-inflammatory activity has also been described for these fungal polysaccharides. It seems the combination of different fungal extracts would send multiple stimuli to the immune system increasing intracellular reactions and interactions. Thus, the fungal extract nutraceutical MICODIGEST 2.0 could be used to reduced the complications after CRC surgery. MICODIGEST 2.0 is available since 2016 without any adverse effect reported.
For all these reasons we have designed a double-bind randomized clinical trial to evaluate the effect of MICODEGIST 2.0 on the complications after surgery with curative intent for CRC.
Apart from this purpose, we have also set the following secondary objectives:
- To evaluate the safety of MICODIGEST 2.0 in CRC patients.
- To evaluate the effect of MICODIGEST 2.0 on feal microbiome composition and diversity.
- To evaluate the effect of MICODIGEST 2.0 on inflammatory pattern, dietary pattern and quality of life.
- To analyze the effect of microbiome, inflammatory and dietary pattern on complications after surgery.
- Conditions
- Colorectal Cancer, Surgery--Complications
- Being tested
- MICODIGEST 2.0 supplement, Placebo supplement
- Keywords
- Colorectal Cancer, Surgery Complications, Gut microbiota, Inflammatory pattern, Dietary pattern, Nutraceutical
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICODIGEST 2.0 supplementDietary supplement
MICODIGEST is a nutraceutical which contains 9 different fungal extracts: Ganoderma lucidum, Agaricus blazei, Grifola frondosa, Hericium erinaceus, Cordyceps sinensis, Inonotus obliquus, Pleurotus ostreatus, Polyporus umbellatus y Lentinula edodes
Placebo supplementDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MICODIGEST 2.0 supplement | Experimental | Treatment with MICODIGEST 2.0 will initiate with 10mL/day (before breakfast or before lunch) for 7 days, and rise to 20mL/day (10mL before breakfast and 10 mL before dinner) for 4-6 weeks. Receives: Dietary Supplement: MICODIGEST 2.0 supplement |
| Placebo | Placebo comparator | Treatment with placebo will initiate with 10mL/day (before breakfast or before lunch) for 7 days, and rise to 20 mL/day (before breakfast and before dinner) for 4-6 weeks. Receives: Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complications.
Anastomotic failure, infection, prolonged ileus, systemic complications and other will be measured. Clavien-Dindo classification will be used for grading the severity of these postoperative complications. These analysis will be measured to evaluate the effect of MICODEGIST 2.0 on the complications after surgery with curative intent for CRC.
Measured: week 4-6
Secondary outcomes (7)
Frequency of adverse effects.
Adverse effects will be considered during follow-up and after surgery using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. This analysis will be measured to evaluate the safety of MICODIGEST 2.0 in CRC patients.
Measured: week 1-6
Fecal microbiome composition.
High-quality DNA extraction will be performed in fecal samples. The bacterial 16S ribosomal ribonucleic acid gene will be sequencing on an Illumina MiSeq. Metagenomic species and a database with >200.000 strains will be used to define the microbiome composition. This analysis will be used to evaluate the effect of MICODIGEST 2.0 on feal microbiome composition.
Measured: week 4-6
Neutrophil/Lymphocyte ratio.
Neutrophil/Lymphocyte will be measured dividing the absolute number of neutrophils by the absolute number of lymphocytes from peripheral blood sample. This inflammatory biomarker will be used to evaluate the effect of MICODIGEST 2.0 on inflammatory pattern.
Measured: week 4-6
C reactive protein (CRP) level.
CRP levels (mg/dL) from peripheral blood samples will be measured to evaluate the effect of MICODIGEST 2.0 on inflammatory pattern.
Measured: week 4-6
Tumor Necrosis Factor alpha (TNF-alpha) and interleukin-6 (IL-6) levels.
TNF-apha (pg/mL) and IL-6 (pg/mL) from peripheral blood samples will be measured to evaluate the effect of MICODIGEST 2.0 on inflammatory pattern.
Measured: week 4-6
Dietary pattern assessment.
Patient-Generated Subjective Global Assessment survey (PG-SGA) will be used to assess the nutritional status. At the end of this survey, the patient will be rated nutritionally in one of three categories: "Well-nourished or anabolic" (PG-SGA - A), "Moderately or suspected of being undernourished" (PG-SGA B) and "Severely undernourished" (PG-SGA C). This analysis will be performed to evaluate the effect of MICODIGEST 2.0 on dietary pattern.
Measured: week 4-6
Quality of life assessment.
The 36-item Short Form Health Survey (SF-36) will be used to measure the health-related quality-of-life. The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. This analysis will be perfomed to evaluate the effect of MICODIGEST 2.0 on quality of life.
Measured: week 4-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start28 Jun 2021
- Primary completion1 Sep 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CRC candidates for surgery with curative intent will be considered to include in the study. Patients who fulfill criteria will be screened and randomly allocated to be treated with MICODIGEST 2.0 or placebo previous to the admission. Patients will be also stratified based on tumor location (distal or proximal to splenic flexure). Patients will be followed for 4-6 weeks until surgery intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821258
- Sponsor's protocol ID
- COGOMELO 2.0
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gutierrez-Stampa MA, Aguilar V, Sarasqueta C, Cubiella J, Portillo I, Bujanda L. Impact of the faecal immunochemical test on colorectal cancer survival. BMC Cancer. 2020 Jul 1;20(1):616. doi: 10.1186/s12885-020-07074-y.
PubMed 32611328Gutierrez-Stampa MA, Aguilar V, Sarasqueta C, Cubiella J, Portillo I, Bujanda L. Colorectal Cancer Survival in 50- to 69-Year-Olds after Introducing the Faecal Immunochemical Test. Cancers (Basel). 2020 Aug 25;12(9):2412. doi: 10.3390/cancers12092412.
PubMed 32854370Cubiella J, Gonzalez A, Almazan R, Rodriguez-Camacho E, Fontenla Rodiles J, Dominguez Ferreiro C, Tejido Sandoval C, Sanchez Gomez C, de Vicente Bielza N, Lorenzo IP, Zubizarreta R. pT1 Colorectal Cancer Detected in a Colorectal Cancer Mass Screening Program: Treatment and Factors Associated with Residual and Extraluminal Disease. Cancers (Basel). 2020 Sep 6;12(9):2530. doi: 10.3390/cancers12092530.
PubMed 32899974Abis GSA, Stockmann HBAC, Bonjer HJ, van Veenendaal N, van Doorn-Schepens MLM, Budding AE, Wilschut JA, van Egmond M, Oosterling SJ; SELECT trial study group. Randomized clinical trial of selective decontamination of the digestive tract in elective colorectal cancer surgery (SELECT trial). Br J Surg. 2019 Mar;106(4):355-363. doi: 10.1002/bjs.11117. Epub 2019 Feb 25.
PubMed 30802304Espin Basany E, Solis-Pena A, Pellino G, Kreisler E, Fraccalvieri D, Muinelo-Lorenzo M, Maseda-Diaz O, Garcia-Gonzalez JM, Santamaria-Olabarrieta M, Codina-Cazador A, Biondo S. Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):729-738. doi: 10.1016/S2468-1253(20)30075-3. Epub 2020 Apr 21.
PubMed 32325012Chowdhury AH, Adiamah A, Kushairi A, Varadhan KK, Krznaric Z, Kulkarni AD, Neal KR, Lobo DN. Perioperative Probiotics or Synbiotics in Adults Undergoing Elective Abdominal Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg. 2020 Jun;271(6):1036-1047. doi: 10.1097/SLA.0000000000003581.
PubMed 31469748Tremaroli V, Backhed F. Functional interactions between the gut microbiota and host metabolism. Nature. 2012 Sep 13;489(7415):242-9. doi: 10.1038/nature11552.
PubMed 22972297Morowitz MJ, Babrowski T, Carlisle EM, Olivas A, Romanowski KS, Seal JB, Liu DC, Alverdy JC. The human microbiome and surgical disease. Ann Surg. 2011 Jun;253(6):1094-101. doi: 10.1097/SLA.0b013e31821175d7.
PubMed 21422915Ralls MW, Miyasaka E, Teitelbaum DH. Intestinal microbial diversity and perioperative complications. JPEN J Parenter Enteral Nutr. 2014 Mar-Apr;38(3):392-9. doi: 10.1177/0148607113486482. Epub 2013 May 1.
PubMed 23636012Ottosson F, Brunkwall L, Ericson U, Nilsson PM, Almgren P, Fernandez C, Melander O, Orho-Melander M. Connection Between BMI-Related Plasma Metabolite Profile and Gut Microbiota. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1491-1501. doi: 10.1210/jc.2017-02114.
PubMed 29409054Liu CJ, Zhang YL, Shang Y, Wu B, Yang E, Luo YY, Li XR. Intestinal bacteria detected in cancer and adjacent tissue from patients with colorectal cancer. Oncol Lett. 2019 Jan;17(1):1115-1127. doi: 10.3892/ol.2018.9714. Epub 2018 Nov 15.
PubMed 30655873Yin C, Noratto GD, Fan X, Chen Z, Yao F, Shi D, Gao H. The Impact of Mushroom Polysaccharides on Gut Microbiota and Its Beneficial Effects to Host: A Review. Carbohydr Polym. 2020 Dec 15;250:116942. doi: 10.1016/j.carbpol.2020.116942. Epub 2020 Aug 27.
PubMed 33049854Ma G, Kimatu BM, Zhao L, Yang W, Pei F, Hu Q. In vivo fermentation of a Pleurotus eryngii polysaccharide and its effects on fecal microbiota composition and immune response. Food Funct. 2017 May 24;8(5):1810-1821. doi: 10.1039/c7fo00341b.
PubMed 28513745Chang CJ, Lin CS, Lu CC, Martel J, Ko YF, Ojcius DM, Tseng SF, Wu TR, Chen YY, Young JD, Lai HC. Ganoderma lucidum reduces obesity in mice by modulating the composition of the gut microbiota. Nat Commun. 2015 Jun 23;6:7489. doi: 10.1038/ncomms8489.
PubMed 26102296Diling C, Chaoqun Z, Jian Y, Jian L, Jiyan S, Yizhen X, Guoxiao L. Immunomodulatory Activities of a Fungal Protein Extracted from Hericium erinaceus through Regulating the Gut Microbiota. Front Immunol. 2017 Jun 12;8:666. doi: 10.3389/fimmu.2017.00666. eCollection 2017.
PubMed 28713364
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Clinical Trial to Evaluate the Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery With Curative Intent for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04821258
- Acronym / sponsor ID
- COGOMELO 2.0
- Conditions
- Colorectal Cancer, Surgery--Complications
- Keywords
- Colorectal Cancer, Surgery Complications, Gut microbiota, Inflammatory pattern, Dietary pattern, Nutraceutical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most of Colorectal cancer (CRC) diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used prior to the admission for the prevention of postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in CRC patients after surgery.
It seems the combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Therefore, the fungal extract nutraceutical MICODIGEST 2.0 could be used to reduced the complications after CRC surgery.
Based on this hypothesis, we have designed a double-bind randomized clinical trial to evaluate the effect of MICODIGEST 2.0 on the complications after surgery with curative intent for CRC.
Detailed description
Colorectal cancer (CRC) is one of the most common malignancies in western countries. Most of the CRC diagnosed are candidates for surgical resection with curative intent. Cure rates after surgery vary between 92 % and 67 % depending on the tumor stage. However, colorectal surgery is associated with some complications that could be life-threatening.
Antibiotic prophylaxis is commonly used prior to the admission for the prevention of this postoperative complications. Several studies have shown that antibiotic administration reduces the risk of infections associated with surgery. Nevertheless, this intervention does not modify the mortality and severity of other complications detected. Further, antibiotic prophylaxis could change the intestinal microbiota and promote adverse inflammatory outcomes in CRC patients after surgery.
Fungal polysaccharides have attracted attention because of their role in gut microbiota modulation. It seems that this type of polysaccharides could reduce pathogen levels and stimulate the growth of beneficial microorganism. Anti-inflammatory activity has also been described for these fungal polysaccharides. It seems the combination of different fungal extracts would send multiple stimuli to the immune system increasing intracellular reactions and interactions. Thus, the fungal extract nutraceutical MICODIGEST 2.0 could be used to reduced the complications after CRC surgery. MICODIGEST 2.0 is available since 2016 without any adverse effect reported.
For all these reasons we have designed a double-bind randomized clinical trial to evaluate the effect of MICODEGIST 2.0 on the complications after surgery with curative intent for CRC.
Apart from this purpose, we have also set the following secondary objectives:
- To evaluate the safety of MICODIGEST 2.0 in CRC patients.
- To evaluate the effect of MICODIGEST 2.0 on feal microbiome composition and diversity.
- To evaluate the effect of MICODIGEST 2.0 on inflammatory pattern, dietary pattern and quality of life.
- To analyze the effect of microbiome, inflammatory and dietary pattern on complications after surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- CRC candidates for surgery with curative intent will be considered to include in the study. Patients who fulfill criteria will be screened and randomly allocated to be treated with MICODIGEST 2.0 or placebo previous to the admission. Patients will be also stratified based on tumor location (distal or proximal to splenic flexure). Patients will be followed for 4-6 weeks until surgery intervention.
| Arm | Type | Receives |
|---|---|---|
| MICODIGEST 2.0 supplement | Experimental | Dietary Supplement: MICODIGEST 2.0 supplementTreatment with MICODIGEST 2.0 will initiate with 10mL/day (before breakfast or before lunch) for 7 days, and rise to 20mL/day (10mL before breakfast and 10 mL before dinner) for 4-6 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementTreatment with placebo will initiate with 10mL/day (before breakfast or before lunch) for 7 days, and rise to 20 mL/day (before breakfast and before dinner) for 4-6 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CRC patients who are candidates for surgical treatment with curative intent (risk I-III).
- American Society of Anesthesiologists' Physical Status Classification (ASA) <3.
- Patients aged between 18 and 85 years.
- Eastern Cooperative Oncology Group (ECOG) scale between 0-2.
- Patients with preserved cognitive function.
Key exclusion criteria (6 listed)
- Candidates for neoadjuvant therapy.
- Patients with concomitant carcinoma.
- Allergy to the supplied nutraceutical or presence of malabsorption syndrome.
- Presence of mental disorders
- Patient with active infection or antibiotic therapy in the last month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICODIGEST 2.0 supplementMICODIGEST is a nutraceutical which contains 9 different fungal extracts: Ganoderma lucidum, Agaricus blazei, Grifola frondosa, Hericium erinaceus, Cordyceps sinensis, Inonotus obliquus, Pleurotus ostreatus, Polyporus umbellatus y Lentinula edodes | Dietary supplement | MICODIGEST 2.0 supplement |
| Placebo supplementPlacebo | Dietary supplement | Placebo |
Primary outcome
Rate of complications.
Time frame: week 4-6
Anastomotic failure, infection, prolonged ileus, systemic complications and other will be measured. Clavien-Dindo classification will be used for grading the severity of these postoperative complications. These analysis will be measured to evaluate the effect of MICODEGIST 2.0 on the complications after surgery with curative intent for CRC.
7 secondary outcomes
Frequency of adverse effects.
Time frame: week 1-6
Fecal microbiome composition.
Time frame: week 4-6
Neutrophil/Lymphocyte ratio.
Time frame: week 4-6
C reactive protein (CRP) level.
Time frame: week 4-6
Tumor Necrosis Factor alpha (TNF-alpha) and interleukin-6 (IL-6) levels.
Time frame: week 4-6
Dietary pattern assessment.
Time frame: week 4-6
Quality of life assessment.
Time frame: week 4-6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 32611328Gutierrez-Stampa MA, Aguilar V, Sarasqueta C, Cubiella J, Portillo I, Bujanda L. Impact of the faecal immunochemical test on colorectal cancer survival. BMC Cancer. 2020 Jul 1;20(1):616. doi: 10.1186/s12885-020-07074-y.
- Background: PubMed 32854370Gutierrez-Stampa MA, Aguilar V, Sarasqueta C, Cubiella J, Portillo I, Bujanda L. Colorectal Cancer Survival in 50- to 69-Year-Olds after Introducing the Faecal Immunochemical Test. Cancers (Basel). 2020 Aug 25;12(9):2412. doi: 10.3390/cancers12092412.
- Background: PubMed 32899974Cubiella J, Gonzalez A, Almazan R, Rodriguez-Camacho E, Fontenla Rodiles J, Dominguez Ferreiro C, Tejido Sandoval C, Sanchez Gomez C, de Vicente Bielza N, Lorenzo IP, Zubizarreta R. pT1 Colorectal Cancer Detected in a Colorectal Cancer Mass Screening Program: Treatment and Factors Associated with Residual and Extraluminal Disease. Cancers (Basel). 2020 Sep 6;12(9):2530. doi: 10.3390/cancers12092530.
- Background: PubMed 30802304Abis GSA, Stockmann HBAC, Bonjer HJ, van Veenendaal N, van Doorn-Schepens MLM, Budding AE, Wilschut JA, van Egmond M, Oosterling SJ; SELECT trial study group. Randomized clinical trial of selective decontamination of the digestive tract in elective colorectal cancer surgery (SELECT trial). Br J Surg. 2019 Mar;106(4):355-363. doi: 10.1002/bjs.11117. Epub 2019 Feb 25.
- Background: PubMed 32325012Espin Basany E, Solis-Pena A, Pellino G, Kreisler E, Fraccalvieri D, Muinelo-Lorenzo M, Maseda-Diaz O, Garcia-Gonzalez JM, Santamaria-Olabarrieta M, Codina-Cazador A, Biondo S. Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):729-738. doi: 10.1016/S2468-1253(20)30075-3. Epub 2020 Apr 21.
- Background: PubMed 31469748Chowdhury AH, Adiamah A, Kushairi A, Varadhan KK, Krznaric Z, Kulkarni AD, Neal KR, Lobo DN. Perioperative Probiotics or Synbiotics in Adults Undergoing Elective Abdominal Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg. 2020 Jun;271(6):1036-1047. doi: 10.1097/SLA.0000000000003581.
- Background: PubMed 22972297Tremaroli V, Backhed F. Functional interactions between the gut microbiota and host metabolism. Nature. 2012 Sep 13;489(7415):242-9. doi: 10.1038/nature11552.
- Background: PubMed 21422915Morowitz MJ, Babrowski T, Carlisle EM, Olivas A, Romanowski KS, Seal JB, Liu DC, Alverdy JC. The human microbiome and surgical disease. Ann Surg. 2011 Jun;253(6):1094-101. doi: 10.1097/SLA.0b013e31821175d7.
- Background: PubMed 23636012Ralls MW, Miyasaka E, Teitelbaum DH. Intestinal microbial diversity and perioperative complications. JPEN J Parenter Enteral Nutr. 2014 Mar-Apr;38(3):392-9. doi: 10.1177/0148607113486482. Epub 2013 May 1.
- Background: PubMed 29409054Ottosson F, Brunkwall L, Ericson U, Nilsson PM, Almgren P, Fernandez C, Melander O, Orho-Melander M. Connection Between BMI-Related Plasma Metabolite Profile and Gut Microbiota. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1491-1501. doi: 10.1210/jc.2017-02114.
- Background: PubMed 30655873Liu CJ, Zhang YL, Shang Y, Wu B, Yang E, Luo YY, Li XR. Intestinal bacteria detected in cancer and adjacent tissue from patients with colorectal cancer. Oncol Lett. 2019 Jan;17(1):1115-1127. doi: 10.3892/ol.2018.9714. Epub 2018 Nov 15.
- Background: PubMed 33049854Yin C, Noratto GD, Fan X, Chen Z, Yao F, Shi D, Gao H. The Impact of Mushroom Polysaccharides on Gut Microbiota and Its Beneficial Effects to Host: A Review. Carbohydr Polym. 2020 Dec 15;250:116942. doi: 10.1016/j.carbpol.2020.116942. Epub 2020 Aug 27.
- World Health Organization. Cancer Today. International Agency for Research on Cancer. (2020)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MICODIGEST 2.0 supplement in people with Colorectal Cancer and Surgery--Complications, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complications. (time frame: week 4-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821258, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.