Anastomotic ComplicationINULINENCT05860322
The Effect of Inulin Supplementation on Colorectal Surgery Outcomes
A study testing Inulin in people with Anastomotic Complication, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Colorectal cancer (CRC) is the third most diagnosed cancer in Canada. The most common surgical procedure in patients with CRC is an intestinal resection followed by a reconnection to rejoin the ends of the remaining bowel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Complication
- What is being tested?
- Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2023to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with a colorectal cancer and who present for elective colorectal surgery
Who cannot join
- Emergency surgery for perforation/obstruction.
- Use of antibiotics within 4 weeks prior to surgery (other than usual antibiotic prophylaxis).
- Presence of preoperative ileostomy or colostomy.
- Intestinal surgery within 4 weeks prior to colonic surgery.
- Active asthma.
- Presence of familial adenomatous polyposis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Carole Richard, MD, 514-890-8000, carole.richard.med@ssss.gouv.qc.ca
About this study
Official title: The Effect of Inulin Supplementation on Colonic Healing and Surgical Outcomes Following Colorectal Surgery
Colorectal cancer (CRC) is the third most diagnosed cancer in Canada. The most common surgical procedure in patients with CRC is an intestinal resection followed by a reconnection to rejoin the ends of the remaining bowel. Among the postoperative complications, leaking of this intestinal connection is notably feared, affecting up to 20% of patients. These leaks are characterized by impaired intestinal healing and are associated with severe infections and even death.
Various studies have shown that gut microbiota, the bacteria that live in the digestive tract, plays an essential role in intestinal healing following surgery. These results support the possibility of enhancing intestinal healing through supplements that act as an energy source for gut bacteria. Indeed, animal studies have shown that inulin supplementation, a fiber commonly found in plants, improves intestinal healing following bowel surgery. However, no studies in humans have evaluated its effects on CRC surgery patients.
This study aims to determine feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery.
Read the detailed description
Based on preliminary data, our working hypotheses are that the gut microbiome plays a fundamental role in postoperative healing and that manipulation of preoperative microbiota using inulin will improve postoperative healing and prevent potential development of anastomotic leaks.
The pilot study aims to evaluate the feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery. The project has two main components, a clinical study, and a translational research. A randomized, multi-center, triple-blind, placebo-controlled clinical trial will be conducted to evaluate the impact of inulin supplementation on the clinical and oncological outcomes of inulin supplementation before elective colorectal oncological surgery. Mucosal, blood and fecal samples of patients with inulin supplementation will be compared with samples of patients without inulin supplementation.
The study objectives are:
- Determine the tolerance of colorectal cancer patients to inulin supplementation before surgery.
- Assess the effect of inulin supplementation on colonic healing and the rate of AL.
- Determine the impact of inulin supplementation on the gut microbiota, the inflammatory markers, and the gut barrier function.
- Assess the effect of inulin supplementation on CRC local and distant recurrence after surgery.
Identification of study participants
Patients who are about to undergo an oncological colorectal surgery will be recruited in the CHUM. Informed consent will be obtained from the patient before enrollment in the study.
Patients will be randomized to the inulin group (intervention group) or to the placebo group (control group). A stratified randomization will be conducted according to the sex (1- Male, 2-Female), the cancer location (1- Right and transverse colon, 2-Left colon and sigmoid, 3-Rectum) and the cancer grade.
Patients randomized to the intervention group will receive inulin supplementation for two weeks, preceding the surgery. Inulin will be given at a dosage of 10g/day divided in two doses. To foster compliance, the inulin will be provided in a calendar pill organizer. Patients randomized to the control group will receive a placebo for two weeks, twice a day. Placebo pills will be identical in appearance to the inulin pills. A total of 40 patients, 20 in each group, will be included in the pilot study.
Adequate colonic preparation will also be given to all the patients, including oral mechanical bowel preparation, oral antibiotics the day before surgery and intravenous antibiotics before surgical incision.
Collection of stool samples
Feces will be collected according to International Human Microbiome Standards (IHMS) guidelines (SOP 03). Two pre-operative specimens will be collected for each enrolled patient: pre-inulin/placebo supplementation and post-inulin/placebo supplementation.
Blood samples
Standard blood tests will be conducted for the participating patients. Supplementary volume will be collected during the per-operative test, before the surgery and at post-op day 3. Blood will be collected in two tubes to assess complete blood counts and to obtained serum.
Intraoperative mucosal sample
A mucosal biopsy coming from colonic anastomosis consist of a fragment from the transection line at the anastomosis. The specimen will be collected in a sterile tube and snap frozen.
Statistical Design
R, Stata and Prism will be used to perform the statistical analysis. Decision to use non-parametric tests is based on data normality (Shapiro-Wilk test) and homoscedasticity (Bartlett's test) tests. Multiple comparisons will be evaluated statistically by 1-way analysis of variance (ANOVA) or by Kruskal-Wallis test. Statistically significant differences will then be evaluated by two-tailed Student's t or Wilcoxon test. Multiple testing is corrected via False Discovery Rate estimation. For pre-supplementation and post-supplementation samples, a paired Student's t-test or paired Wilcoxon test will be used. For comparison of 2 groups, an unpaired Student's t-test or unpaired Wilcoxon test will be used.
- Conditions
- Anastomotic Complication
- Being tested
- Inulin, Placebo
- Keywords
- colorectal cancer, inuline, anastomotic leak, anastomotic healing
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDietary supplement
Inulin is a water soluble non-digestible carbohydrate, and it is available in more than 36,000 species of plants. It is often used as dietary fiber and has obtained the "Generally recognized as safe" status (GRAS) by the Food and Drug Administration (FDA).
PlaceboOther
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| Inulin group | Experimental | Patients randomized to the intervention group will receive inulin supplementation for 14 days, preceding the surgery. Inulin will be given at a dosage of 10g/day divided in two doses. Receives: Dietary Supplement: Inulin |
| Control group | Placebo comparator | Patients randomized to the control group will receive a placebo for 14 days, two times a day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Gastrointestinal Symptom Rating Scale (GSRS) before and after treatment.
The GSRS is a seven-point Likert-type scale with response options ranging from 1 (no discomfort at all) to 7 (very severe discomfort). It includes 15 questions that assess various gastrointestinal symptoms.
Measured: The questionnaires will be completed before treatment and after treatment (within the first week after surgery)
Change in the Digestion-associated Quality of Life Questionnaire (DQLQ) before and after treatment.
The DQLQ is a 9-item questionnaire that uses a seven-point Likert-type scale to assess the impact of gastrointestinal symptoms on quality of life. The response options range from 'never' to 'always'.
Measured: The questionnaires will be completed before treatment and after treatment (within the first week after surgery)
Secondary outcomes (5)
Anastomotic leak rate
All patients presenting with suspicious clinical features, such as worrisome laboratory results, post-operative fever, or abnormal physical examination findings, will undergo radiological examinations to confirm an anastomotic leak.
Measured: Anastomotic leaks will be assessed clinically and, if needed, radiologically evaluated. The incidence of anastomotic leak will include cases that experience this complication during the first 12 weeks after surgery.
White blood cell count on post-operative day 3
The white blood cell count will be monitored on post-operative day 3 to check for signs of infection or inflammation.
Measured: Blood sample will be collected on post-operative day 3.
C-reactive protein (CRP) on post-operative day 3
The CRP will be monitored on post-operative day 3 to check for signs of infection or inflammation.
Measured: Blood sample will be collected on post-operative day 3.
Change in fecal calprotectin levels before treatment and after treatment (on the day before surgery).
Changes in fecal calprotectin levels will be monitored to assess colonic inflammation.
Measured: Stool samples will be collected before treatment and after treatment (on the day before surgery)
MUC2 levels in the mucosal sample
MUC2 levels will assess the amount of mucin present in the mucosa, which is important for colonic healing after surgery
Measured: The mucosal sample will be collected during surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic ComplicationStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole Richard, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860322
- Sponsor's protocol ID
- 2023-11342
- Other IDs
- 2023
- Acronym
- INULINE
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inulin Supplementation on Colonic Healing and Surgical Outcomes Following Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05860322
- Acronym / sponsor ID
- INULINE / 2023-11342
- Conditions
- Anastomotic Complication
- Keywords
- colorectal cancer, inuline, anastomotic leak, anastomotic healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer (CRC) is the third most diagnosed cancer in Canada. The most common surgical procedure in patients with CRC is an intestinal resection followed by a reconnection to rejoin the ends of the remaining bowel. Among the postoperative complications, leaking of this intestinal connection is notably feared, affecting up to 20% of patients. These leaks are characterized by impaired intestinal healing and are associated with severe infections and even death.
Various studies have shown that gut microbiota, the bacteria that live in the digestive tract, plays an essential role in intestinal healing following surgery. These results support the possibility of enhancing intestinal healing through supplements that act as an energy source for gut bacteria. Indeed, animal studies have shown that inulin supplementation, a fiber commonly found in plants, improves intestinal healing following bowel surgery. However, no studies in humans have evaluated its effects on CRC surgery patients.
This study aims to determine feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery.
Detailed description
Based on preliminary data, our working hypotheses are that the gut microbiome plays a fundamental role in postoperative healing and that manipulation of preoperative microbiota using inulin will improve postoperative healing and prevent potential development of anastomotic leaks.
The pilot study aims to evaluate the feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery. The project has two main components, a clinical study, and a translational research. A randomized, multi-center, triple-blind, placebo-controlled clinical trial will be conducted to evaluate the impact of inulin supplementation on the clinical and oncological outcomes of inulin supplementation before elective colorectal oncological surgery. Mucosal, blood and fecal samples of patients with inulin supplementation will be compared with samples of patients without inulin supplementation.
The study objectives are:
- Determine the tolerance of colorectal cancer patients to inulin supplementation before surgery.
- Assess the effect of inulin supplementation on colonic healing and the rate of AL.
- Determine the impact of inulin supplementation on the gut microbiota, the inflammatory markers, and the gut barrier function.
- Assess the effect of inulin supplementation on CRC local and distant recurrence after surgery.
Identification of study participants
Patients who are about to undergo an oncological colorectal surgery will be recruited in the CHUM. Informed consent will be obtained from the patient before enrollment in the study.
Patients will be randomized to the inulin group (intervention group) or to the placebo group (control group). A stratified randomization will be conducted according to the sex (1- Male, 2-Female), the cancer location (1- Right and transverse colon, 2-Left colon and sigmoid, 3-Rectum) and the cancer grade.
Patients randomized to the intervention group will receive inulin supplementation for two weeks, preceding the surgery. Inulin will be given at a dosage of 10g/day divided in two doses. To foster compliance, the inulin will be provided in a calendar pill organizer. Patients randomized to the control group will receive a placebo for two weeks, twice a day. Placebo pills will be identical in appearance to the inulin pills. A total of 40 patients, 20 in each group, will be included in the pilot study.
Adequate colonic preparation will also be given to all the patients, including oral mechanical bowel preparation, oral antibiotics the day before surgery and intravenous antibiotics before surgical incision.
Collection of stool samples
Feces will be collected according to International Human Microbiome Standards (IHMS) guidelines (SOP 03). Two pre-operative specimens will be collected for each enrolled patient: pre-inulin/placebo supplementation and post-inulin/placebo supplementation.
Blood samples
Standard blood tests will be conducted for the participating patients. Supplementary volume will be collected during the per-operative test, before the surgery and at post-op day 3. Blood will be collected in two tubes to assess complete blood counts and to obtained serum.
Intraoperative mucosal sample
A mucosal biopsy coming from colonic anastomosis consist of a fragment from the transection line at the anastomosis. The specimen will be collected in a sterile tube and snap frozen.
Statistical Design
R, Stata and Prism will be used to perform the statistical analysis. Decision to use non-parametric tests is based on data normality (Shapiro-Wilk test) and homoscedasticity (Bartlett's test) tests. Multiple comparisons will be evaluated statistically by 1-way analysis of variance (ANOVA) or by Kruskal-Wallis test. Statistically significant differences will then be evaluated by two-tailed Student's t or Wilcoxon test. Multiple testing is corrected via False Discovery Rate estimation. For pre-supplementation and post-supplementation samples, a paired Student's t-test or paired Wilcoxon test will be used. For comparison of 2 groups, an unpaired Student's t-test or unpaired Wilcoxon test will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inulin group | Experimental | Dietary Supplement: InulinPatients randomized to the intervention group will receive inulin supplementation for 14 days, preceding the surgery. Inulin will be given at a dosage of 10g/day divided in two doses. |
| Control group | Placebo comparator | Other: PlaceboPatients randomized to the control group will receive a placebo for 14 days, two times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a colorectal cancer and who present for elective colorectal surgery
Key exclusion criteria (6 listed)
- Emergency surgery for perforation/obstruction.
- Use of antibiotics within 4 weeks prior to surgery (other than usual antibiotic prophylaxis).
- Presence of preoperative ileostomy or colostomy.
- Intestinal surgery within 4 weeks prior to colonic surgery.
- Active asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InulinInulin is a water soluble non-digestible carbohydrate, and it is available in more than 36,000 species of plants. It is often used as dietary fiber and has obtained the "Generally recognized as safe" status (GRAS) by the Food and Drug Administration (FDA). | Dietary supplement | Inulin group |
| PlaceboPlacebo control | Other | Control group |
Primary outcome
Change in the Gastrointestinal Symptom Rating Scale (GSRS) before and after treatment.
Time frame: The questionnaires will be completed before treatment and after treatment (within the first week after surgery)
The GSRS is a seven-point Likert-type scale with response options ranging from 1 (no discomfort at all) to 7 (very severe discomfort). It includes 15 questions that assess various gastrointestinal symptoms.
Change in the Digestion-associated Quality of Life Questionnaire (DQLQ) before and after treatment.
Time frame: The questionnaires will be completed before treatment and after treatment (within the first week after surgery)
The DQLQ is a 9-item questionnaire that uses a seven-point Likert-type scale to assess the impact of gastrointestinal symptoms on quality of life. The response options range from 'never' to 'always'.
5 secondary outcomes
Anastomotic leak rate
Time frame: Anastomotic leaks will be assessed clinically and, if needed, radiologically evaluated. The incidence of anastomotic leak will include cases that experience this complication during the first 12 weeks after surgery.
White blood cell count on post-operative day 3
Time frame: Blood sample will be collected on post-operative day 3.
C-reactive protein (CRP) on post-operative day 3
Time frame: Blood sample will be collected on post-operative day 3.
Change in fecal calprotectin levels before treatment and after treatment (on the day before surgery).
Time frame: Stool samples will be collected before treatment and after treatment (on the day before surgery)
MUC2 levels in the mucosal sample
Time frame: The mucosal sample will be collected during surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
Related trials for Anastomotic Complication
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Active, not recruiting
Feasibility Study of Middle Segmental Gastrectomy (MSG) for Gastric Cancer.
Gastric Cancer, Gastric Adenocarcinoma
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carole Richard, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin in people with Anastomotic Complication, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carole Richard, MD (514 890-8000, carole.richard.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Gastrointestinal Symptom Rating Scale (GSRS) before and after treatment. (time frame: The questionnaires will be completed before treatment and after treatment (within the first week after surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.