Prebiotics for Ulcerative Colitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Prior colectomy, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how prebiotics, plant-based foods that promote the growth of beneficial gut bacteria, can affect gut health in people with ulcerative colitis (UC). Participants will take prebiotics for 8 weeks, starting either at the beginning or halfway through the trial, to observe changes in their gut bacteria. Individuals diagnosed with UC and currently experiencing symptoms, despite using certain medications, may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to understanding the potential benefits of prebiotics for UC patients.

Will I have to stop taking my current medications?

You can continue taking your current medications like 5-aminosalicylates, immunomodulators, corticosteroids, and biologic therapy, as long as you haven't started or changed the dose in the last 30 to 60 days. However, you will need to stop using probiotics or other dietary supplements during the trial.

What prior data suggests that this prebiotic is safe for patients with IBD?

Research has shown that prebiotics, such as inulin, are generally safe for individuals with ulcerative colitis. Studies have found these supplements unlikely to cause serious side effects. For instance, one study found that fructans, a type of prebiotic, reduced colitis symptoms without major issues. Some individuals might experience minor side effects like bloating or gas, but these are typically not serious. Overall, prebiotics appear to be well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using prebiotics for ulcerative colitis because they offer a unique approach by focusing on gut health. Unlike standard treatments, which often include anti-inflammatory drugs and immunosuppressants, prebiotics work by feeding beneficial gut bacteria, potentially restoring gut balance and reducing inflammation naturally. This method could offer a gentler alternative with fewer side effects, addressing the root cause rather than just the symptoms.

What evidence suggests that prebiotics might be an effective treatment for ulcerative colitis?

Research has shown that prebiotics, such as inulin-type fructans, may benefit some people with ulcerative colitis. One study found that 77% of patients taking a high dose experienced improvement, compared to 33% taking a low dose. Other studies have reported improved symptoms and reduced inflammation in the stool. However, the overall evidence remains mixed. Some reviews suggest that while prebiotics can alleviate symptoms, they might not prevent the condition from recurring. Participants in this trial will receive prebiotics either at Week 0 or Week 8 to assess their effects on ulcerative colitis symptoms. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Ulcerative Colitis or other forms of Inflammatory Bowel Disease. Participants should be interested in how diet affects their condition and willing to take prebiotic supplements. They'll need to provide stool samples and dietary information regularly.

Inclusion Criteria

I have been diagnosed with ulcerative colitis through a biopsy.

I am experiencing noticeable symptoms from my condition.

I am using certain medications without changes in the last 30 days.

Exclusion Criteria

Active alcohol or non-cannabinoid substance abuse

Pregnancy or lactation

Concerns for non-compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Dietary composition is assessed at baseline

1 week

1 visit (in-person)

Treatment

Participants receive an 8-week course of prebiotic supplementation starting at either week 0 or week 8

8 weeks

2 visits (in-person) for stool sample collection at weeks 0 and 8

Follow-up

Participants are monitored for clinical remission and microbial composition changes

8 weeks

1 visit (in-person) at week 16

What Are the Treatments Tested in This Trial?

Interventions

• Prebiotic

Trial Overview The study tests the effects of prebiotics on gut health over 16 weeks. Participants will start taking a prebiotic supplement either immediately or after an initial 8-week period, to see if it changes the gut microbiome and improves symptoms.

How Is the Trial Designed?

Group I: Prebiotic at Week 0 Experimental Treatment 1 Intervention

Group II: Prebiotic at Week 8 Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Xylo-oligosaccharide (XOS) has been shown to promote the growth of beneficial gut bacteria in patients with ulcerative colitis (UC) in clinical remission, suggesting it can help restore gut microbiota balance.

In a study involving five UC patients and five healthy volunteers, XOS fermentation increased the abundance of beneficial bacterial groups like Roseburia and Lactobacillus, indicating its potential as a prebiotic for maintaining remission in UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Xylo-Oligosaccharide on the Gut Microbiota of Patients With Ulcerative Colitis in Clinical Remission. Li, Z., Li, Z., Zhu, L., et al.[2022]

In a study of 17 patients with active ulcerative colitis, 6 weeks of prebiotic galactooligosaccharide (GOS) supplementation did not significantly reduce clinical scores or inflammation, but it did improve stool consistency, with normal stool proportions increasing from 49% to 70%.

The prebiotic treatment led to an increase in beneficial gut bacteria, specifically Bifidobacterium and Christensenellaceae, but this effect was only observed in patients with less active disease, suggesting that the benefits of prebiotics may vary based on the severity of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic Galactooligosaccharide Supplementation in Adults with Ulcerative Colitis: Exploring the Impact on Peripheral Blood Gene Expression, Gut Microbiota, and Clinical Symptoms. Wilson, B., Eyice, Ö., Koumoutsos, I., et al.[2021]

In a double-blind study involving 195 patients with quiescent ulcerative colitis, Bifidobacterium breve strain Yakult (BFM) did not significantly improve relapse-free survival compared to a placebo over 48 weeks, leading to the study's discontinuation due to lack of efficacy.

An exploratory analysis showed no impact of BFM on intestinal microbiota, and while three mild adverse events were reported, a direct causal relationship with the treatment could not be established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis. Matsuoka, K., Uemura, Y., Kanai, T., et al.[2018]

Probiotics containing bifidobacteria have shown significant efficacy in inducing remission in patients with active ulcerative colitis (UC), with a relative risk of 1.73 when using FDA-recommended assessment scales.

No significant effects were found for maintaining remission in UC patients when comparing probiotics to placebo or mesalazine, highlighting the need for validated scales to accurately assess treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Probiotics, Prebiotic Inulin-Type Fructans, and Synbiotics in Human Ulcerative Colitis: A Systematic Review and Meta-Analysis. Astó, E., Méndez, I., Audivert, S., et al.[2020]

The study evaluated the effects of esters formed from prebiotics and short chain fatty acids on the gut microbiota of ulcerative colitis (UC) patients, using an in vitro fermentation model to analyze changes in microbial composition and SCFA production.

Results indicated that butyrylated fructooligosaccharides (B-FOS) and propionylated fructooligosaccharides (P-FOS) not only promoted beneficial bacteria like Bifidobacterium but also inhibited harmful bacteria, suggesting their potential to restore gut balance and reduce inflammation in UC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermentation patterns of prebiotics fructooligosaccharides-SCFA esters inoculated with fecal microbiota from ulcerative colitis patients. Chen, W., Tan, D., Yang, Z., et al.[2023]

In a study of 25 patients with mild to moderate ulcerative colitis, a high dose of 15 g/day of inulin-type fructans significantly improved clinical outcomes, with 77% of patients showing a response compared to 33% in the lower dose group.

The benefits of inulin-type fructans were linked to increased production of butyrate, a beneficial short-chain fatty acid, rather than changes in the composition of gut bacteria, suggesting that metabolic shifts in the microbiota may be more crucial for improving ulcerative colitis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin-type fructans improve active ulcerative colitis associated with microbiota changes and increased short-chain fatty acids levels. Valcheva, R., Koleva, P., Martínez, I., et al.[2020]

Arabino-oligosaccharides (AOS) derived from sugar beet pulp showed potential prebiotic effects similar to fructo-oligosaccharides (FOS) in promoting the growth of beneficial bacteria like Bifidobacterium and Lactobacillus in fecal samples from ulcerative colitis patients and healthy controls.

The fermentation of AOS led to increased production of acetate and a decrease in pH, suggesting that AOS could help improve inflammatory conditions in ulcerative colitis patients, although further human trials are necessary to confirm these health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro fermentation of sugar beet arabino-oligosaccharides by fecal microbiota obtained from patients with ulcerative colitis to selectively stimulate the growth of Bifidobacterium spp. and Lactobacillus spp. Vigsnæs, LK., Holck, J., Meyer, AS., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6546336/

Inulin-type fructans improve active ulcerative colitis ... Fructans significantly reduced colitis in the high-dose group, with 77% of patients showing a clinical response versus 33% in the low-dose group (P = 0.04).

2. sciencedirect.com sciencedirect.com/science/article/pii/S0966842X23003256

A review on the use of prebiotics in ulcerative colitis Previous studies have found significant improvements in clinical activity indices, decreases in faecal calprotectin, and increases in SCFA production in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02093767

Oligofructose-enriched Inulin for the Treatment of Mild to ... Based on the efficacy of inulin and oligofructose in treating experimental colitis and emerging evidence suggesting probiotics are efficacious in maintaining ...

4. mdpi.com mdpi.com/2072-6643/11/2/293

The Efficacy of Probiotics, Prebiotic Inulin-Type Fructans ... No significant effects were observed on the maintenance of remission for placebo-controlled or mesalazine-controlled studies. We conclude that a validated scale ...

5. gastroenterologyadvisor.com gastroenterologyadvisor.com/news/prebiotics-not-effective-remission-in-ibd/

Prebiotics Likely Not Effective at Inducing Remission in IBD Prebiotics are mildly beneficial for inducing clinical remission in ulcerative colitis, but overall evidence does not support efficacy for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03653481

Study Details | NCT03653481 | Treating IBD With Inulin The purpose of this study is to see how the prebiotic inulin changes the gut bacteria (microbiome) of children and young adults with IBD and determine if this ...

7. crohnscolitisfoundation.org crohnscolitisfoundation.org/safety-and-feasibility-of-oligofructose-enriched-inulin-pediatric-inflammatory-bowel-disease-short

Safety and Feasibility of Oligofructose-Enriched Inulin in ... The purpose of this clinical research study is to test whether taking a prebiotic fiber supplement, called inulin, can beneficially shift the ...

8. jn.nutrition.org jn.nutrition.org/article/S0022-3166(22)09451-2/fulltext

Inulin and Oligofructose in Chronic Inflammatory Bowel ... Because of their excellent safety profile and lack of serious side effects, there is little contraindication to the consumption of prebiotics, probiotics, and ...