Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery for Colorectal Cancer

NCT04821258 | Unknown

• 1 other identifier: COGOMELO 2.0
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer; Surgery--Complications

Keywords

Colorectal Cancer; Surgery Complications; Gut microbiota; Inflammatory pattern; Dietary pattern; Nutraceutical

Outcome Measures

Primary Outcomes (1)

• 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.

  week 4-6

Secondary Outcomes (7)

• Frequency of adverse effects.

  week 1-6

• Fecal microbiome composition.

  week 4-6

• Neutrophil/Lymphocyte ratio.

  week 4-6

• C reactive protein (CRP) level.

  week 4-6

• Tumor Necrosis Factor alpha (TNF-alpha) and interleukin-6 (IL-6) levels.

  week 4-6

Study Arms (2)

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.

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.

Dietary Supplement: Placebo supplement

Interventions

MICODIGEST 2.0 supplement DIETARY_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

MICODIGEST 2.0 supplement

Placebo supplement DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Related Publications (26)

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  PMID: 35576566 DERIVED

Related Links

• World Health Organization. Cancer Today. International Agency for Research on Cancer. (2020)

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Joaquín Cubiella, MD PhD

CONTACT

0034988385824; joaquin.cubiella.fernandez@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 29, 2021
• Study Start: April 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 29, 2021

Record last verified: 2021-03