Clinical trial · Interventional
Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery for Colorectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MICODIGEST 2.0 supplement | Dietary Supplement | — | UNRESOLVED |
| Placebo supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MICODIGEST 2.0 supplement
- description
- 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.
- interventionNames
- Dietary Supplement: MICODIGEST 2.0 supplement
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Dietary Supplement: Placebo supplement
Primary outcomes (1)
- measure
- Rate of complications.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. CRC patients who are candidates for surgical treatment with curative intent (risk I-III). 2. American Society of Anesthesiologists' Physical Status Classification (ASA) \<3. 3. Patients aged between 18 and 85 years. 4. Eastern Cooperative Oncology Group (ECOG) scale between 0-2. 5. Patients with preserved cognitive function. 6. Patient's authorization after reading the study information sheet. Exclusion Criteria: 1. Candidates for neoadjuvant therapy. 2. Patients with concomitant carcinoma. 3. Allergy to the supplied nutraceutical or presence of malabsorption syndrome. 4. Presence of mental disorders 5. Patient with active infection or antibiotic therapy in the last month. 6. Previous colorectal surgery
References
Publications (26)
- BACKGROUNDGutierrez-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. PMID 32611328
- BACKGROUNDGutierrez-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. PMID 32854370
- BACKGROUNDCubiella 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. PMID 32899974
- BACKGROUNDAbis 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. PMID 30802304
- BACKGROUNDEspin 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. PMID 32325012
- BACKGROUNDChowdhury 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.