Anti-Inflammatory Fibres for Ulcerative Colitis

(PAIF-UC Trial)

Overseen By Anissa Armet, PhD, RD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Antibiotics, Probiotics, Prebiotics, others

Disqualifiers: Crohn disease, Celiac, Pregnancy, others

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

69 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to determine the clinical effects of two different dietary fibre supplements, acacia gum (AG) and microcrystalline cellulose (MCC), in patients with ulcerative colitis. The main question it aims to answer is: Can the fibre supplements reduce gut inflammation (fecal calprotectin)? Researchers will compare AG and MCC to a placebo (a look-alike substance that contains no fibre) to see if the fibre supplements improve inflammation in ulcerative colitis. Participants will add their assigned fibre supplement or placebo to their usual diet daily for 6 weeks. They will visit the clinic at baseline, week 3, and week 6 to provide samples (stool, blood) and complete various questionnaires.

Who Is on the Research Team?

Eytan Wine, MD, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for men and women with ulcerative colitis, who have a fecal calprotectin level over 250 µg/g. Women must be menstruating and on contraceptives. Participants should have mild disease severity based on specific scoring indexes, weigh more than 50kg, and not have changed their IBD-related medications in the last three months.

Inclusion Criteria

My ulcerative colitis is considered mild.

My fecal calprotectin level is above 250 µg/g.

I have been diagnosed with ulcerative colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive their assigned fibre supplement or placebo daily for 6 weeks

6 weeks

3 visits (in-person) at baseline, week 3, and week 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants achieving the primary outcome at week 6 may continue their assigned treatment for an additional 6 weeks

6 weeks

1 visit (in-person) at week 12

What Are the Treatments Tested in This Trial?

Interventions

• Acacia Gum
• Microcrystalline Cellulose
• Placebo

Trial Overview The trial tests if dietary fibre supplements (acacia gum or microcrystalline cellulose) can reduce gut inflammation compared to a placebo. Over six weeks, participants will add these supplements to their diet and undergo clinic visits for sample collection and questionnaires.

How Is the Trial Designed?

Group I: Microcrystalline Cellulose Experimental Treatment 1 Intervention

Microcrystalline cellulose is a dietary fibre that is non-viscous and and non-fermentable. Female participants consume 12.5 grams each day for the first two days of the intervention, then consume 25 grams each day for the rest of the six-week intervention. Male participants consume 17.5 grams each day for the first two days of the intervention, then consume 35 grams each day for the rest of the six-week intervention. Those participants who voluntarily extend their treatment for an additional six weeks will continue with consuming the full dose daily.

Group II: Acacia Gum Experimental Treatment 1 Intervention

Acacia gum is a dietary fibre with low-viscosity and is fermentable. Female participants consume 12.5 grams each day for the first two days of the intervention, then consume 25 grams each day for the rest of the six-week intervention. Male participants consume 17.5 grams each day for the first two days of the intervention, then consume 35 grams each day for the rest of the six-week intervention. Those participants who voluntarily extend their treatment for an additional six weeks will continue with consuming the full dose daily.

Group III: Maltodextrin Placebo Group 1 Intervention

Maltodextrin is a digestible carbohydrate. It is provided in isocaloric doses to the dietary fibres. Female participants consume 6.3 grams each day for the first two days of the intervention, then consume 12.5 grams each day for the rest of the six-week intervention. Male participants consume 8.8 grams each day for the first two days of the intervention, then consume 17.5 grams each day for the rest of the six-week intervention.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Weston Family Foundation

Collaborator

Trials

4

Recruited

290+

Weston Family Foundation

Collaborator