Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 15, 2021
Open Peer Review Period: Oct 15, 2021 - Dec 10, 2021
Date Accepted: Feb 15, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Effect of the Nutraceutical "MICODIGEST 2.0" on the Colorectal Cancer Surgery With Curative Intent Complications Rate: A Study Protocol for a Placebo-Controlled Double-blind Randomized Clinical Trial
ABSTRACT
Background:
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 for the prevention of postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in CRC patients. It seems that the combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity.
Objective:
Based on this hypothesis, we have designed a double-bind randomized clinical trial to evaluate the effect of the nutraceutical fungal extract MICODIGEST 2.0 on the complications of surgery for CRC resection.
Methods:
CRC candidates for surgery will be considered for inclusion in the study. After evaluation in the multidisciplinary tumor board, patients who fulfill criteria will be screened, stratified according to the tumor location and randomly allocated to be treated with MICODIGEST 2.0 or placebo. Treatment will be continued until admission for surgery (4-6 weeks). Participants will also undergo a medical and clinical evaluation, which will include baseline and before admission quality of life, microbiome composition, inflammatory and nutritional status, adverse events and adherence. The main endpoint of the study is the surgery complication rate. We will evaluate them using the Clavien-Dindo classification. It would be necessary to recruit a total of 144 patients to find a relevant clinical difference. We will also evaluate the effect of the nutraceutical on microbiome composition, inflammatory response, nutritional status and quality of life, as well as the effect of these variables on the surgical complications.
Results:
This study was funded in 2020 by the Center for Industrial Technology Development. The recruitment started in September 2021 and is expected to be completed in September 2022. Data will be analyzed and the results will be disseminated in 2023.
Conclusions:
The results of this protocol study could help to reduce the surgery complications in patients with CRC. This study could also identify new features associated with colorectal surgery complications. In summary, this study trial could improve the management of CRC patients. Clinical Trial: Clinical Trials.gov. Identifier: NCT04821258. Registered on March 29, 2021.
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