Inulin Supplementation for Anastomotic Complication

(INULINE Trial)

Not yet recruiting at 1 trial location

Overseen By Nassima Taleb

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Antibiotics

Disqualifiers: Emergency surgery, Active asthma, others

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking inulin, a plant fiber, before colorectal cancer surgery can improve healing and reduce leaks at the surgery site. Leaks can lead to serious infections, making prevention crucial. Participants will take either inulin or a placebo for 14 days before surgery. Individuals with colorectal cancer scheduled for elective surgery, without recent antibiotic use or an active asthma condition, might qualify for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those who have used antibiotics within 4 weeks before surgery.

Is there any evidence suggesting that inulin supplementation is likely to be safe for humans?

Research has shown that inulin is generally safe for people when taken in amounts up to 20 grams per day. Clinical studies found this amount well-tolerated, with participants not experiencing significant side effects. Inulin, a type of fiber found in plants, is known to improve gut health. While animal studies have shown that inulin can aid healing after bowel surgery, its effects have not been studied in humans undergoing colorectal cancer surgery. However, existing research suggests that taking up to 20 grams per day is unlikely to cause serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Inulin is unique because it is a natural dietary fiber that may help reduce anastomotic complications after surgery by promoting gut health. Unlike standard treatments for these complications, which often involve surgical techniques or antibiotics, inulin works by improving the gut microbiota balance, potentially leading to better healing and fewer infections. Researchers are excited about inulin because it offers a non-invasive, simple pre-surgery supplement that could enhance recovery and reduce the risk of complications without the side effects associated with more invasive interventions.

What evidence suggests that inulin supplementation might be an effective treatment for anastomotic complications?

This trial will compare inulin supplementation with a placebo to assess its effects on intestinal healing after bowel surgery. Research suggests that inulin, a type of fiber, may aid intestinal healing post-surgery. Animal studies have shown that inulin can support gut recovery after surgery. As a prebiotic, inulin feeds beneficial bacteria in the intestines, potentially improving gut health and healing. Some studies have also found that prebiotics like inulin can boost immune function and balance gut bacteria in surgery patients. However, no human studies have specifically examined these effects in patients undergoing colorectal cancer surgery. ^{2 4 6 7 8}

Who Is on the Research Team?

Carole Richard, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have colorectal cancer and am scheduled for elective surgery.

Exclusion Criteria

I have a stoma from previous surgery.

I have been diagnosed with familial adenomatous polyposis.

I haven't taken antibiotics in the last 4 weeks, except for prevention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive inulin or placebo supplementation for 14 days before surgery

2 weeks

Daily self-administration

Surgery

Participants undergo elective colorectal surgery

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative complications and healing, including blood tests and mucosal sample collection

3 days

In-patient monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of anastomotic leaks and quality of life

12 weeks

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Inulin
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Inulin group Experimental Treatment 1 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 group Placebo Group 1 Intervention

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

Inulin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Inulin for:

• Dietary supplement
• Prebiotic

Approved in United States as Inulin for:

• Dietary supplement
• Prebiotic

Approved in Canada as Inulin for:

• Dietary supplement
• Prebiotic

Approved in Japan as Inulin for:

• Dietary supplement
• Prebiotic

Approved in China as Inulin for:

• Dietary supplement
• Prebiotic

Approved in Switzerland as Inulin for:

• Dietary supplement
• Prebiotic

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Inulin fructans, derived from chicory root, are safe and well-tolerated dietary fibers that can be consumed up to 20 g per day, providing various health benefits.

They have direct effects on gut health, such as improving bowel function and promoting beneficial gut bacteria, as well as indirect effects on blood lipids and the immune system, suggesting potential for further research in energy balance and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of Inulin Fructans in the Human Diet. Schaafsma, G., Slavin, JL.[2021]

Inulin-rich meat products, such as chorizo sausages and cooked ham, significantly reduced colon polyp formation by 49% in an animal model, indicating their potential as preventive foods against colorectal cancer.

The functional meat products not only increased beneficial short-chain fatty acids like propionate and butyrate but also altered gut microbiota composition, enhancing beneficial bacteria while reducing pro-inflammatory populations, suggesting a multifaceted approach to cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Processed Meat Products Re-designed Towards Inulin-rich Functional Foods Reduce Polyps in Two Colorectal Cancer Animal Models. Fernández, J., Ledesma, E., Monte, J., et al.[2023]

In a 3-month randomized, placebo-controlled trial involving 24 obese patients, the intake of inulin-type fructans (ITF) significantly increased levels of beneficial gut bacteria, specifically Bifidobacterium, and reduced fecal calprotectin, a marker of gut inflammation.

The study suggests that ITF may help improve gut health in obese individuals by decreasing inflammation and potentially influencing gut microbiota-derived metabolites, although it did not significantly change short-chain fatty acid levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic dietary fibre intervention improves fecal markers related to inflammation in obese patients: results from the Food4Gut randomized placebo-controlled trial. Neyrinck, AM., Rodriguez, J., Zhang, Z., et al.[2022]

In a study using fecal cultures from healthy and morbidly obese adults, different prebiotics were tested, revealing that 1-kestose had the most significant impact on gut microbiota composition and metabolic activity.

Prebiotic modulation led to increased Bacteroides and Faecalibacterium in obese individuals, while normal-weight individuals showed higher levels of Bifidobacterium and Faecalibacterium, highlighting the need for tailored prebiotic treatments based on individual microbiota profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Evaluation of Different Prebiotics on the Modulation of Gut Microbiota Composition and Function in Morbid Obese and Normal-Weight Subjects. Nogacka, AM., Salazar, N., Arboleya, S., et al.[2023]

Fermentation supernatant fractions of inulin significantly increased short-chain fatty acids (SCFA) and decreased harmful bile acids, showing potential protective effects against colorectal cancer.

In human colon cell lines, particularly in early-stage cancer cells (LT97), the fermentation supernatant induced apoptosis and inhibited cell growth, suggesting that prebiotic fibers like inulin could play a role in cancer chemoprevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermentation products of inulin-type fructans reduce proliferation and induce apoptosis in human colon tumour cells of different stages of carcinogenesis. Munjal, U., Glei, M., Pool-Zobel, BL., et al.[2022]

Fermentation of various dietary fibers, particularly oat β-glucan, significantly enhances gut barrier integrity and mucus production, suggesting these fibers can improve gut health.

In models of compromised gut barriers, oat β-glucan and maltodextrin fermentation products were particularly effective in restoring gut integrity, highlighting their potential as therapeutic agents for gut-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of fermentation products of prebiotic fibres on gut barrier and immune functions in vitro. Pham, VT., Seifert, N., Richard, N., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12219383/

Differential effects of inulin and fructooligosaccharides on ... A 4-week inulin intervention effectively improves glycemic metabolism in overweight/obese individuals. A 4-week placebo had no effects on ...

2. withpower.com withpower.com/trial/phase-anastomotic-complication-7-2023-7f706

Inulin Supplementation for Anastomotic Complication Indeed, animal studies have shown that inulin supplementation, a fiber commonly found in plants, improves intestinal healing following bowel surgery. However, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8970830/

The Prebiotic Potential of Inulin-Type Fructans Evidence from studies included in the current review suggest that ITF have a prebiotic effect on the intestinal microbiota, promoting the abundances of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0899900718313200

Effects of prebiotics on immunologic indicators and ... Prebiotic intake improved and changed immunologic indicators and intestinal microbiota structure in colorectal patients in the perioperative period.

5. cambridge.org cambridge.org/core/services/aop-cambridge-core/content/view/640DDDED310BBB4545CAFD37B8F09563/S0954422407249686a.pdf/inulin-and-oligofructose-as-prebiotics-in-the-prevention-of-intestinal-infections-and-diseases.pdf

inulin-and-oligofructose-as-prebiotics-in-the-prevention-of- ... Furthermore, studies in various animal models have shown that inulin and oligofructose accelerate the recovery of beneficial bacteria, slow down pathogen growth ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05860322

The Effect of Inulin Supplementation on Colorectal Surgery ... Among the postoperative complications, leaking of this intestinal connection is notably feared, affecting up to 20% of patients. These leaks are characterized ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10620476/

Evaluation of safety of inulin and oligofructose as dietary fiber A series of clinical studies has been reported which shows that up to 20 g/day of inulin and/or oligofructose is well tolerated. As foods marketed in the United ...

8. careacross.com careacross.com/clinical-trials/trial/NCT05860322

The Effect of Inulin Supplementation on Colorectal Surgery ... Among the postoperative complications, leaking of this intestinal connection is notably feared, affecting up to 20% of patients. These leaks are characterized ...