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NCT05860322Not yet recruiting

The Effect of Inulin Supplementation on Colorectal Surgery Outcomes

The Effect of Inulin Supplementation on Colonic Healing and Surgical Outcomes Following Colorectal Surgery

Source: ClinicalTrials.gov · Last updated 16 May 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
26 Apr 2023
Start date
1 Aug 2023
Primary completion date
1 Aug 2028
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
NCT number
NCT05860322

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 1 Aug 2023 to the primary completion date, 1 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of antibiotics within 4 weeks prior to surgery (other than usual antibiotic prophylaxis).
  • Intestinal surgery within 4 weeks prior to colonic surgery.

Other illness

  • Emergency surgery for perforation/obstruction.

Other

  • Presence of preoperative ileostomy or colostomy.
  • Active asthma.
  • Presence of familial adenomatous polyposis.

Who the study is looking for

  • Patients with a colorectal cancer and who present for elective colorectal surgery

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier de l'Universite de Montreal (CHUM)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.