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?

This trial aims to determine if two types of fiber supplements, acacia gum and microcrystalline cellulose, can reduce gut inflammation in people with ulcerative colitis. Researchers will compare these supplements to a placebo to assess their effectiveness. Participants will add the fiber or placebo to their diet for six weeks and visit the clinic for tests. Individuals diagnosed with ulcerative colitis who haven't changed their related medications in the last three months might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding new dietary approaches for managing ulcerative colitis.

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

You don't need to stop your current medications for this trial, but your IBD-related medications should have been stable for at least three months before starting. Some minor adjustments to your medication are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both acacia gum (AG) and microcrystalline cellulose (MCC) are generally safe to consume. Research indicates that individuals can tolerate up to 40 grams of acacia gum daily for four weeks without major side effects, suggesting the trial's amounts should be safe. For microcrystalline cellulose, repeated doses up to 35 grams per person showed no harmful effects, aligning with the trial's usage. Both fibers are considered safe and are under further study to determine their potential in reducing inflammation in people with ulcerative colitis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for ulcerative colitis because they explore the potential of dietary fibers, which is a different approach compared to the standard anti-inflammatory drugs and immunosuppressants. Acacia gum is unique because it is a low-viscosity, fermentable fiber that could promote gut health by acting as a prebiotic. On the other hand, microcrystalline cellulose is non-fermentable and non-viscous, offering a different kind of dietary fiber that might have a soothing effect on the digestive system. These fibers could provide a gentle, natural alternative to managing inflammation, which is an appealing option for patients seeking non-drug-based treatments.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

Studies have shown that acacia gum (AG), one of the treatments in this trial, can significantly reduce inflammation in colitis models, especially at high doses. This suggests it might help with ulcerative colitis, a condition characterized by gut inflammation. Research on microcrystalline cellulose (MCC), another treatment option in this trial, indicates it can block proteins that cause inflammation in colitis models, thereby reducing inflammation. This trial is studying both fibers for their potential to decrease gut inflammation in ulcerative colitis. These findings are promising, but more research is needed to confirm these effects in people with this condition. ^{1 5 6 7 8}

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8105628/

Anti-inflammatory effects of acacia and guar gum in 5- ... Acacia and guar gum separately showed significant anti-inflammatory effects in murine colitis, and furthermore, high dose acacia led to an ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06515210

Personalized Anti-Inflammatory Fibres in Ulcerative Colitis The goal of this clinical trial is to determine the clinical effects of two different dietary fibre supplements, acacia gum (AG) and microcrystalline cellulose ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023095634

Ameliorating effects of Acacia arabica and Ocimum ... The results also showed an improvement in colitis. Thus, the combination of A. arabica and O. basilicum is effective in controlling ulcerative colitis.

4. ctv.veeva.com ctv.veeva.com/study/personalized-anti-inflammatory-fibres-in-ulcerative-colitis

Personalized Anti-Inflammatory Fibres in Ulcerative Colitis The goal of this clinical trial is to determine the clinical effects of two different dietary fibre supplements, acacia gum (AG) and microcrystalline cellulose ...

5. pubs.acs.org pubs.acs.org/doi/pdf/10.1021/acsomega.1c00302

Manipulation of Gut Microbiota Using Acacia Gum ... From the proximate results, the major nutrient component of AG is a carbohydrate with a significant portion, 83.0 and. 85.2% for AG1 and AG2, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8296006/

Manipulation of Gut Microbiota Using Acacia Gum ... (2008), all subjects tolerated the given high dose of AG up to 40 g/d for 4 weeks with no significant adverse symptoms. ... In the United States and European ...

7. cir-safety.org cir-safety.org/sites/default/files/Acacia_senegal_Derived_Ingredients.pdf

Amended Safety Assessment of Acacia Senegal Gum and ... The additional data requirements to determine the safety of Acacia Senegal Gum and Acacia Senegal Gum. Extract were outlined as follows. • For ...

8. cir-safety.org cir-safety.org/sites/default/files/Acacia_senegal.pdf

Amended Safety Assessment of Acacia Senegal Gum and ... Enclosed is the Draft Amended Report on the Safety Assessment of Acacia Senegal Gum and Accacia Senegal Gum. Extract as Used in Cosmetics. The ...