Clinical trial NCT04821258: Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery for Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Surgery--Complications
Keywords: Colorectal Cancer
Surgery Complications
Gut microbiota
Inflammatory pattern
Dietary pattern
Nutraceutical
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of complications.
timeFrame: week 4-6
Secondary outcomes:
measure: Frequency of adverse effects.
timeFrame: week 1-6
measure: Fecal microbiome composition.
timeFrame: week 4-6
measure: Neutrophil/Lymphocyte ratio.
timeFrame: week 4-6
measure: C reactive protein (CRP) level.
timeFrame: week 4-6
measure: Tumor Necrosis Factor alpha (TNF-alpha) and interleukin-6 (IL-6) levels.
timeFrame: week 4-6
measure: Dietary pattern assessment.
timeFrame: week 4-6
measure: Quality of life assessment.
timeFrame: week 4-6
Other outcomes:
Locations:
Study officials:
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