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Dietary Supplement
Inulin Supplementation for Anastomotic Complication (INULINE Trial)
N/A
Waitlist Available
Led By Carole Richard, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood sample will be collected on post-operative day 3.
Awards & highlights
INULINE Trial Summary
This trial aims to evaluate if inulin, a fiber found in plants, can improve healing after colorectal surgery, reducing infections & death.
Who is the study for?
This trial is for patients with colorectal cancer who are scheduled for elective bowel surgery. It's designed to see if taking inulin, a plant fiber, before their operation can help improve healing and reduce complications.Check my eligibility
What is being tested?
The study is testing the effects of inulin supplementation versus a placebo on the outcomes of colorectal surgery. Participants will be randomly assigned to receive either inulin or a placebo before their surgery.See study design
What are the potential side effects?
Inulin is generally considered safe but may cause digestive discomfort such as bloating, gas, and an upset stomach. Since it's a dietary fiber, these side effects are typically mild.
INULINE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the questionnaires will be completed before treatment and after treatment (within the first week after surgery)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the questionnaires will be completed before treatment and after treatment (within the first week after surgery)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the Digestion-associated Quality of Life Questionnaire (DQLQ) before and after treatment.
Change in the Gastrointestinal Symptom Rating Scale (GSRS) before and after treatment.
Secondary outcome measures
Anastomotic leak rate
C-reactive protein (CRP) on post-operative day 3
Change in fecal calprotectin levels before treatment and after treatment (on the day before surgery).
+2 moreINULINE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inulin groupExperimental Treatment1 Intervention
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.
Group II: Control groupPlacebo Group1 Intervention
Patients randomized to the control group will receive a placebo for 14 days, two times a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inulin
2011
Completed Phase 4
~780
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,597 Total Patients Enrolled
Carole Richard, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a stoma from previous surgery.I haven't taken antibiotics in the last 4 weeks, except for prevention.I have been diagnosed with familial adenomatous polyposis.I have colorectal cancer and am scheduled for elective surgery.I have active asthma.I had emergency surgery for a tear or blockage in my intestines.I have not had intestinal surgery in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Inulin group
- Group 2: Control group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators currently enrolling participants for this research?
"Contrary to initial expectations, this medical trial is not actively recruiting subjects; the clinicaltrials.gov portal reveals that it was initially posted on August 1st 2023 and subsequently updated on May 5th 2023. Fortunately, 3 other trials are available for enrollment right now."
Answered by AI
What are the central goals of this experiment?
"The primary objectives of this study are to measure the changes in Digestion-associated Quality of Life Questionnaire (DQLQ) scores pre and post treatment. Secondary endpoints include monitoring white blood cell count, mucin levels from a mucosal sample, and C-reactive protein on postoperative day 3 for signs of infection or inflammation."
Answered by AI
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