The Effect of Inulin Supplementation on Colorectal Surgery Outcomes

NCT05860322 | Not Yet Recruiting DMC

• 1 other identifier: 2023-11342
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anastomotic Complication

Keywords

colorectal cancer; inuline; anastomotic leak; anastomotic healing

Outcome Measures

Primary Outcomes (2)

• 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.

  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'.

  The questionnaires will be completed before treatment and after treatment (within the first week after surgery)

Secondary Outcomes (5)

• Anastomotic leak rate

  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

  Blood sample will be collected on post-operative day 3.

• C-reactive protein (CRP) on post-operative day 3

  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).

  Stool samples will be collected before treatment and after treatment (on the day before surgery)

• MUC2 levels in the mucosal sample

  The mucosal sample will be collected during surgery.

Study Arms (2)

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.

Dietary Supplement: Inulin

Control group

PLACEBO COMPARATOR

Patients randomized to the control group will receive a placebo for 14 days, two times a day.

Other: Placebo

Interventions

Inulin DIETARY_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).

Inulin group

Placebo OTHER

Placebo control

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak

Interventions

Inulin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Carole Richard, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carole Richard, MD

CONTACT

514 890-8000; carole.richard.med@ssss.gouv.qc.ca

Nassima Taleb

CONTACT

514 890-8000; nassima.taleb.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 16, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)