Prebiotics for Ulcerative Colitis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Disqualifiers: Prior colectomy, Active malignancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD. Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.
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 data supports the effectiveness of the treatment Prebiotic, Oligofructose-enriched inulin (OEI), Prebiotin for ulcerative colitis?
Research shows that inulin-type fructans, similar to oligofructose-enriched inulin, can reduce symptoms of ulcerative colitis by improving gut health and increasing beneficial short-chain fatty acids. This suggests that OEI may also help manage ulcerative colitis by promoting a healthier gut environment.12345
Is the prebiotic oligofructose-enriched inulin (OEI) safe for humans?
How does the prebiotic treatment for ulcerative colitis differ from other treatments?
The prebiotic treatment using oligofructose-enriched inulin (OEI) is unique because it focuses on altering the gut microbiota to improve health, specifically by increasing beneficial bacteria like Bifidobacterium and Lactobacillus, and enhancing the production of short-chain fatty acids, which can help reduce inflammation and maintain remission in ulcerative colitis patients.12357
Research Team
Eligibility Criteria
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 am between 18 and 85 years old.
I have been diagnosed with ulcerative colitis through a biopsy.
I am experiencing noticeable symptoms from my condition.
See 3 more
Exclusion Criteria
Concerns for non-compliance
I have been hospitalized.
I need urgent surgery in my abdomen.
See 5 more
Trial Timeline
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
Treatment Details
Interventions
- Prebiotic (Prebiotic)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Prebiotic at Week 0Experimental Treatment1 Intervention
Group II: Prebiotic at Week 8Active Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLALos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Trials
1594
Patients Recruited
10,430,000+
References
Effects of Xylo-Oligosaccharide on the Gut Microbiota of Patients With Ulcerative Colitis in Clinical Remission. [2022]Gut microbiota dysbiosis is closely associated with ulcerative colitis (UC). Prebiotic therapy is a potential approach for UC management especially remission maintaining. Xylo-oligosaccharide (XOS) is an efficient prebiotic with proven health benefits and few side effects. However, the effects of XOS on the gut microbiota of patients with UC have not been investigated previously. The aim of this study was to evaluate the prebiotic effects of XOS on the fecal microbiota of patients with UC in clinical remission using an in vitro fermentation model. Five patients with UC in clinical remission and five healthy volunteers were enrolled in this study. Fresh fecal samples of UC patients were diluted and inoculated in yeast extract, casitone and fatty acid (YCFA) medium alone or with XOS. After fermentation for 48 h, samples were collected for 16S rDNA sequencing to investigate the gut microbiota composition. Differences in the gut microbiota between healthy volunteers and UC patients in clinical remission were detected using original fecal samples. Subsequently, the differences between the YCFA medium alone or with XOS samples were analyzed to illustrate the effects of XOS on the gut microbiota of UC patients. In both principal coordinate analysis (PCoA) and principal component analysis (PCA), the fecal samples of UC patients differed from those of healthy volunteers. Linear discriminant analysis effect size (LEfSe) analysis revealed that the relative abundances of g_Roseburia and g_Lachnospiraceae_ND3007_group were higher in healthy volunteers than in UC patients, while o_Lactobacillales abundance showed the opposite trend (P < 0.05). Wilcoxon rank-sum test bar plot showed that the abundances of g_Eubacterium_halli_group and g_Lachnospiraceae_ND3007_group were higher in the healthy volunteers than in the UC patients (P < 0.05). In addition, in UC patients, the Wilcoxon rank-sum test showed that XOS fermentation promoted the growth of bacterial groups including g_Roseburia, g_Bifidobacterium, and g_Lactobacillus, which is beneficial for recovery of intestinal diseases. These results suggest that XOS can relieve dysbiosis in the feces of UC patients in clinical remission and thus represent a potential prebiotic material for maintaining remission.
Prebiotic Galactooligosaccharide Supplementation in Adults with Ulcerative Colitis: Exploring the Impact on Peripheral Blood Gene Expression, Gut Microbiota, and Clinical Symptoms. [2021]Prebiotics may promote immune homeostasis and reduce sub-clinical inflammation in humans. This study investigated the effect of prebiotic galactooligosaccharide (GOS) supplementation in colonic inflammation. Seventeen patients with active ulcerative colitis (UC) consumed 2.8 g/d GOS for 6 weeks. At baseline and 6 weeks, gene expression (microarray), fecal calprotectin (ELISA), microbiota (16S rRNA), short-chain fatty acids (SCFAs; gas-liquid chromatography), and clinical outcomes (simple clinical colitis activity index (SCCAI), gastrointestinal symptom rating scale (GSRS), and Bristol stool form scale (BSFS)) were measured. Following prebiotics, clinical scores (SCCAI), fecal calprotectin, SCFAs, and pH were unchanged. Five genes were upregulated and two downregulated. Normal stool proportion (BSFS) increased (49% vs. 70%, p = 0.024), and the incidence (46% vs. 23%, p = 0.016) and severity (0.7 vs. 0.5, p = 0.048) of loose stool (GSRS), along with urgency (SCCAI) scores (1.0 vs. 0.5, p = 0.011), were reduced. In patients with a baseline SCCAI ≤2, prebiotics increased the relative abundance of Bifidobacterium from 1.65% (1.97) to 3.99% (5.37) (p = 0.046) and Christensenellaceae from 0.13% (0.33) to 0.31% (0.76) (p = 0.043). Prebiotics did not lower clinical scores or inflammation but normalized stools. Bifidobacterium and Christensenellaceae proportions only increased in patients with less active diseases, indicating that the prebiotic effect may depend on disease activity. A controlled study is required to validate these observations.
Inulin-type fructans improve active ulcerative colitis associated with microbiota changes and increased short-chain fatty acids levels. [2020]The intestinal microbiota is involved in ulcerative colitis (UC) pathogenesis. Prebiotics are hypothesized to improve health through alterations to gut microbiota composition and/or activity. Our aim was therefore to determine if inulin-type fructans induce clinical benefits in UC, and identify if benefits are linked to compositional and/or functional shifts of the luminal (fecal) and mucosal (biopsy) bacterial communities. Patients (n = 25) with mild/moderately active UC received 7.5 g (n = 12) or 15 g (n = 13) daily oral oligofructose-enriched inulin (Orafti®Synergy1) for 9 weeks. Total Mayo score, endoscopic activity and fecal calprotectin were assessed. Fecal and mucosal bacterial communities were characterized by 16S rRNA tag sequencing, and short chain fatty acids (SCFA) production were measured in fecal samples. 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). Fructans increased colonic butyrate production in the 15 g/d dose, and fecal butyrate levels were negatively correlated with Mayo score (r = -0.50; P = 0.036). The high fructan dose led to an increased Bifidobacteriaceae and Lachnospiraceae abundance but these shifts were not correlated with improved disease scores. In summary, this pilot study revealed that 15 g/d dose inulin type fructans in UC produced functional but not compositional shifts of the gut microbiota, suggesting that prebiotic-induced alterations of gut microbiota metabolism are more important than compositional changes for the benefits in UC. The findings warrant future well-powered controlled studies for the use of β-fructans as adjunct therapy in patients with active UC.
Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis. [2018]Fermented milk products containing Bifidobacterium breve strain Yakult (BFM) may improve clinical status in ulcerative colitis (UC) patients.
Fermentation patterns of prebiotics fructooligosaccharides-SCFA esters inoculated with fecal microbiota from ulcerative colitis patients. [2023]Ulcerative colitis (UC) is believed to arise from an imbalance between the intestinal microbiota and mucosal immunity, leading to excessive intestinal inflammation. Modulating the gut microbial community through dietary components presents a valuable strategy in aiding the treatment of UC. In this study, esters formed by binding of well-known prebiotics, fructooligosaccharides (FOS), with short chain fatty acids (SCFAs) via both enzymatic and chemical methods were evaluated for their impact on the gut microbiota of UC patients. An in vitro human colonic fermentation model was employed to monitor changes in total carbohydrates and SCFAs production during the fermentation of these esters by microbiota from patients with active and remission UC. The results showed that pronounced abundance of [Ruminococcus]_gnavus_group, Escherichia_Shigella, Lachnoclostridium, Klebsiella and other potential pathogens were detected in the fecal samples from UC patients, with a milder condition observed during the remission phase. Significant higher levels of corresponding SCFA were observed in the groups with addition of FOS-SCFAs esters during fermentation. Butyrylated fructooligosaccharides (B-FOS) and propionylated fructooligosaccharides (P-FOS) by enzymatic synthesis successfully promoted the proliferation of Bifidobacterium and inhibited Clostridium_sensu_stricto_1 and Klebsiella. Overall, B-FOS and P-FOS exhibit promising potential for restoring intestinal homeostasis and alleviating intestinal inflammation in individuals with UC.
The Efficacy of Probiotics, Prebiotic Inulin-Type Fructans, and Synbiotics in Human Ulcerative Colitis: A Systematic Review and Meta-Analysis. [2020]Studies of probiotics, fructan-type prebiotics, and synbiotics in patients with ulcerative colitis (UC) show significant heterogeneity in methodology and results. Here, we study the efficacy of such interventions and the reasons for the heterogeneity of their results. Eligible random controlled trials were collected from the PUBMED and SCOPUS databases. A total of 18 placebo-controlled and active treatment-controlled (i.e., mesalazine) studies were selected with a Jadad score ≥ 3, including 1491 patients with UC. Data for prebiotics and synbiotics were sparse and consequently these studies were excluded from the meta-analysis. The UC remission efficacy of probiotics was measured in terms of relative risk (RR) and odds ratio (OR). Significant effects were observed in patients with active UC whenever probiotics containing bifidobacteria were used, or when adopting the US Food and Drug Administration (FDA)-recommended scales (UC Disease Activity Index and Disease Activity Index). By the FDA recommended scales, the RR was 1.55 (CI95%: 1.13⁻2.15, p-value = 0.007, I² = 29%); for bifidobacteria-containing probiotics, the RR was 1.73 (CI95%: 1.23⁻2.43, p-value = 0.002, I² = 35%). No significant effects were observed on the maintenance of remission for placebo-controlled or mesalazine-controlled studies. We conclude that a validated scale is necessary to determine the state of patients with UC. However, probiotics containing bifidobacteria are promising for the treatment of active UC.
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. [2021]The potential prebiotic properties of arabino-oligosaccharides (AOS) derived from sugar beet pulp was studied using mixed cultures of human fecal bacteria from patients with ulcerative colitis (UC), in remission or with active disease, and in healthy controls. These results were compared to those for fructo-oligosaccharides (FOS), which are known to have a prebiotic effect. Fermentation studies were carried out using a small-scale static batch system, and changes in the fecal microbial communities and metabolites were monitored after 24 h by quantitative real-time PCR and short-chain fatty acid analysis. With a few minor exceptions, AOS affected the communities similarly to what was seen for FOS. Quantitative real-time PCR revealed that Bifidobacterium spp. and Lactobacillus spp. were selectively increased after fermentation of AOS or FOS by fecal microbiota derived from UC patients. The stimulation of growth of Lactobacillus spp. and Bifidobacterium spp. was accompanied by a high production of acetate and hence a decrease of pH. The fermentation of AOS may help improve the inflammatory conditions in UC patients through stimulation of bacteria eliciting anti-inflammatory responses and through production of acetate. AOS may therefore represent a new prebiotic candidate for reduction of the risk of flare-ups in UC patients. However, human trials are needed to confirm a health-promoting effect.