Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)POSBIO-CRCNCT07268846
Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
A study testing Postbiotic in people with Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), run by AC Camargo Cancer Center at 1 site in Brazil.
Trial summary
The treatment of colorectal cancer, in the absence of metastases, is primarily based on surgical removal. Colorectal surgery, which involves resecting part of the intestine and restoring intestinal continuity, carries a risk of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)
- What is being tested?
- Postbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with malignant neoplasm of the large intestine, specifically adenocarcinoma.
- Patients over 18 years of age, of both sexes.
- Patients who agree to participate in the study and sign the informed consent form.
Who cannot join
- Emergency or urgent surgeries.
- Cytoreductive surgeries involving intraoperative intraperitoneal chemotherapy.
- Extended surgeries for the treatment of recurrent tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
A.C.Camargo Cancer Center
São Paulo, São Paulo, 01509-010
Bruna E Catin Kupper, PhD, +55 (11) 2189-5010 ext. 2832, bruna.catin@accamargo.org.br
About this study
Official title: Randomized Clinical Trial on the Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
The treatment of colorectal cancer, in the absence of metastases, is primarily based on surgical removal. Colorectal surgery, which involves resecting part of the intestine and restoring intestinal continuity, carries a risk of complications. This study aims to evaluate whether oral supplementation with a postbiotic at a dose of 900 mg for 7 days prior to surgery reduces the rate of postoperative complications.
Read the detailed description
Recent studies have underscored the influence of gut microbiota composition on the incidence of postoperative complications following intestinal surgery. Microorganisms naturally present in the intestinal environment produce a variety of substances that may exert either beneficial or detrimental effects on human health. Emerging evidence indicates a protective role for metabolites derived from these microorganisms.
Pharmacological modulation of these metabolites for human supplementation has led to the development of postbiotics. Recent research has demonstrated that certain postbiotics, particularly short-chain fatty acids such as butyrate, possess immunomodulatory properties and contribute to maintaining the integrity of the intestinal barrier in inflammatory bowel disease.
This study will include two groups of participants: one group will receive a daily supplementation of 900 mg of butyrate, while the other will receive a placebo, for seven days prior to surgery. A total of 164 participants are expected to be enrolled, and the study will be conducted over a two-year period.
The present proposal aims to assess the effectiveness of a postbiotic in reducing postoperative complications in colorectal cancer surgery, with an anticipated 50% reduction in the overall postoperative complication rate in the intervention arm. If confirmed, such a reduction would represent a substantial decrease in morbidity and healthcare costs throughout the treatment pathway for this specific population.
- Conditions
- Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)
- Being tested
- Postbiotic, Placebo
- Keywords
- Colorectal cancer surgery, Postbiotic, colorectal cancer, intestinal microbiota, nutritional intervention, inflammation
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Breast Neoplasms, Lymphoma, Multiple Myeloma, Colorectal Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostbioticDietary supplement
Butyrate directly influences the gastrointestinal microbiota and exhibits potent anti-inflammatory effects by locally inhibiting inflammatory mediators in the intestinal epithelium, thereby enhancing mucosal barrier integrity. It also mitigates excessive inflammation through the modulation of immune cells, promoting the activity of M2 macrophages and regulatory T cells.
Furthermore, butyrate is thought to modulate intestinal receptor hypersensitivity, leading to reduced intraluminal pressure and improved peristaltic function. This mechanism may underlie its therapeutic role in clinical conditions associated with diarrhea and in preventing the loss of water, sodium, chloride, and potassium.
PlaceboOther
Participants will receive three oral capsules per day, containing no active substance and identical in appearance to the study capsules, for seven consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Participants will receive three oral capsules per day, containing no active substance and identical in appearance to the study capsules, for seven consecutive days. Receives: Other: Placebo |
| Oral postbiotic supplementation ( Butyrate) | Experimental | The formulation will contain tributyrin as the active compound, which acts directly on the large intestine. Tributyrin serves as a source of butyrate, a short-chain fatty acid. Total daily dose of 900 mg, divided into three 300 mg capsules, for seven consecutive days. Receives: Dietary Supplement: Postbiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications within 30 days (Clavien-Dindo grade II or higher)
Clinical or surgical postoperative complication - Clavien-Dindo grade II or higher .
Measured: 30 days after colorectal cancer surgery
Secondary outcomes (4)
C-reactive protein (CRP) levels after surgery
Serum C-reactive protein (CRP) concentration (mg/L) measured preoperatively (within 7 days before surgery) and on postoperative day 3. The primary comparison will be the CRP level on postoperative day 3 between the postbiotic and control groups, as well as the change in CRP from baseline to postoperative day 3.
Measured: Baseline (within 7 days before surgery) and postoperative day 3
Gastrointestinal postoperative complications (Clavien-Dindo grade II or higher)
Gastrointestinal postoperative complication : Clavien-Dindo grade II or higher within 30 days after colorectal cancer surgery (including, for example, prolonged postoperative ileus, bowel subocclusion or obstruction, anastomotic leakage, enteric fistula, intra-abdominal abscess, or gastrointestinal bleeding requiring intervention).
Measured: 30 days after surgery
Nutritional status and body composition assessed by preoperative computed tomography
Preoperative body composition assessment will be performed using abdominal computed tomography scans obtained for colorectal cancer staging. Skeletal muscle area at the level of L3, skeletal muscle index (SMI), and visceral adipose tissue area will be quantified. The prevalence of sarcopenia, visceral obesity, and sarcopenic obesity will be described, and the associations between these body composition phenotypes and postoperative complications within 30 days will be explored.
Measured: Baseline (preoperative CT scan performed within 8 weeks before surgery); postoperative complications assessed within 30 days after surgery
Dietary intake assessment using a Food Frequency Questionnaire (FFQ)
Habitual dietary intake will be assessed preoperatively using a validated Food Frequency Questionnaire (FFQ). Associations between identified dietary intake patterns and postoperative complications within 30 days will be explored, as well as potential interactions between habitual diet and the response to preoperative postbiotic supplementation.
Measured: Baseline (preoperative assessment); postoperative complications assessed within 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Aguiar Jr, AC Camargo Cancer Center
- Investigators
- Samuel A Junior, MD, PhD, Principal investigator, A.C.Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268846
- Sponsor's protocol ID
- CEP3592/24
- Acronym
- POSBIO-CRC
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No