Probiotics for Ulcerative Colitis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Must not be taking: Antibiotics, Immunosuppressants
Disqualifiers: Pregnancy, HIV, Hepatitis, Cancer, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing freeze-dried PRIM-DJ2727 capsules taken by mouth in people with ulcerative colitis who are not currently experiencing symptoms. The treatment might work by changing gut bacteria to help keep the disease from coming back.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it mentions that you should be on stable maintenance therapy for ulcerative colitis. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment PRIM-DJ2727, Lyophilized Fecal Microbiota Transplantation, for ulcerative colitis?
Research shows that fecal microbiota transplantation (FMT) can increase microbial diversity and help induce remission in ulcerative colitis. Additionally, probiotics have been found to help maintain remission in patients with this condition.
12345Is the treatment safe for humans?
Research on probiotics and fecal microbiota transplantation (FMT) for ulcerative colitis shows that these treatments are generally safe, with most studies reporting no significant adverse events. In one study, 93.2% of patients experienced no adverse events after FMT, and another study found no adverse reactions after probiotic treatment.
56789How is the treatment PRIM-DJ2727 different from other treatments for ulcerative colitis?
PRIM-DJ2727 is unique because it involves lyophilized fecal microbiota transplantation, which is a novel way to change the gut bacteria to help treat ulcerative colitis, unlike traditional treatments that may use drugs or probiotics alone.
510111213Eligibility Criteria
Adults over 18 with Ulcerative Colitis in remission can join this trial. They must have had active UC within the last year, be on stable therapy, and agree to use birth control if applicable. Exclusions include other GI conditions, certain infections like HIV or Hepatitis B/C, compromised immune systems, recent FMT or investigational drugs, inability to take oral capsules, pregnancy/breastfeeding intentions during the study.Inclusion Criteria
I have had active ulcerative colitis in the last year.
I agree to use effective birth control during the study.
I am 18 years old or older.
+4 more
Exclusion Criteria
In the opinion of investigator, subject for any reason, should be excluded from the study
I haven't taken any antibiotics in the last 14 days.
I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive lyophilized PRIM-DJ2727 capsules or placebo orally for 12 weeks
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
9 months
Participant Groups
The trial tests lyophilized PRIM-DJ2727 capsules against placebos for preventing Ulcerative Colitis relapse. It involves taking these orally and monitoring gut microbiota changes over time to see how they relate to clinical outcomes compared with a placebo.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Patients with UC will receive FMT capsulesExperimental Treatment1 Intervention
Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors
Group II: Patients with UC will receive placeboPlacebo Group1 Intervention
Patients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
References
Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis. [2022]Recent trials suggest fecal microbiota transplantation (FMT) with repeated enemas and high-diversity FMT donors is a promising treatment to induce remission in ulcerative colitis.
A randomised double-blind placebo-controlled trial with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 for maintenance of remission in ulcerative colitis. [2022]To investigate the clinical effect of treatment with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 (Probio-Tec AB-25) to maintain remission in patients with ulcerative colitis.
Efficacy and safety of fecal microbiota transplantation for treating patients with ulcerative colitis: A systematic review and meta-analysis. [2021]To assess the effect of donor selection, stool procedures and pretreatment with antibiotics on the efficacy and safety of fecal microbiota transplantation (FMT)-treated ulcerative colitis (UC).
Fecal microbiota transplantation versus glucocorticoids for the induction of remission in mild to moderate ulcerative colitis. [2022]To compare efficacy and safety of fecal microbiota transplantation (FMT) with glucocorticoid as induction therapy in ulcerative colitis (UC).
The Efficacy and Safety of Mesalamine and Probiotics in Mild-to-Moderate Ulcerative Colitis: A Systematic Review and Meta-Analysis. [2022]To evaluate the efficacy and safety of mesalamine in conjunction with probiotics for ulcerative colitis.
Fecal microbiota transplantation ameliorates active ulcerative colitis. [2020]Ulcerative colitis (UC) is a complex chronic pathological condition of the gut in which microbiota targeted treatment, such as fecal microbiota transplantation (FMT), has shown an encouraging effect. The aim of the present study was to investigate the efficacy and safety of FMT in patients with mild or moderate UC. A single-center, open-label study was designed, including 47 patients with mild or moderate active UC who received three treatments of fresh FMT via colonic transendoscopic enteral tubing within 1 week. The inflammatory bowel disease questionnaire, partial Mayo scores, colonoscopy, erythrocyte sedimentation rate, C-reactive protein level and procalcitoin values were used to assess the efficacy of FMT and alteration in gut microbiota was detected by 16S ribosomal RNA-sequencing. Before FMT, microbiota Faecalibacterium prausnitzii (F. prausnitzii) levels were significantly decreased in patients with UC compared with healthy donors (P<0.01). At 4 weeks post-FMT, F. prausnitzii levels were significantly increased (P<0.05), and the Mayo score was significantly decreased (1.91±1.07 at baseline vs. 4.02±1.47 at week 4; P<0.001) in patients with UC compared with healthy donors. Steroid-free clinical responses were reported in 37 patients (84.1%), and steroid-free clinical remission was achieved in 31 patients (70.5%) at week 4 post-FMT, however, steroid-free remission was not achieved in any patient. No adverse events were reported in 41 (93.2%) patients after FMT or during the 12-week follow-up. Shannon's diversity index and Chao1 estimator were also improved in patients with UC receiving FMT. In conclusion, the results of the present study suggested that FMT resulted in clinical remission in patients with mild to moderate UC, and that the remission may be associated with significant alterations to the intestinal microbiota of patients with UC. Furthermore, F. prausnitzii may serve as a diagnostic and therapeutic biomarker for the use of FMT in UC.
[Influence of a combination of lactobacilli and bifidobacteria upon disease activity, stool pattern and nutritional status of ulcerative colitis patients]. [2014]A quasi-experimental clinical assay was carried out to assess the tolerance, safety and usefulness of a 4 lactobacili + 1 bifidobacterium combination as adjuvant to the pharmacological treatment of UC Ulcerative colitis patients differing in mucosal change. The effectiveness of the probiotic treatment was assessed from changes in patient's stool pattern, body composition, and selected biochemical indicators of disease activity and nutritional status. Fifty patients entered consecutively in the trial between December 2005-June 2009 (CONTROL GROUP: 29; Treatment Group: 21). Twenty of them completed treatment with probiotics. Effectiveness of regular pharmacological treatment was recorded with 24 control patients. Thirty-six days of probiotic treatment per patient were accumulated. Probiotic treatment obedience rate was 99.3%. Five days of treatment were lost due to non-availability of the product. No adverse reactions were reported after probiotic treatment. Two deaths were recorded after completion of the study, one on each group. Improvement in the quality of the stools [RR Relative risk: 1.69; 95% IC: 0.87-3.27]; frequency [RR: 1.35; 95% IC: 0.15-11.90]; and volume [RR: 1.11; 95% IC: 0.16-7.63] was observed in treated patients, although biological variability prevented these trends to become statistically significant. Probiotic treatment also resulted in reduction of occurrence of nocturnal depositions [RR: 1.75; 95% IC: 0.53-5.73]. Probiotic treatment prevented the onset of undesirable changes in stool pattern of treated patients who presented free of symptoms, but observed effect was no superior to that of medication administered. Probiotic treatment did not influence upon presence of blood in stools. Probiotic treatment also resulted in reduction of disease activity and ESR Erythro-sedimentation rate, respectively [Change in the Clinical Activity Index:
Serial Fecal Microbiota Infusions via Colonoscopy for Active Ulcerative Colitis: A Feasibility, Safety, and Translational Monocentric Italian Study. [2023]The effectiveness of fecal microbiota transplantation (FMT) in ulcerative colitis (UC) remains unclear. This study aimed to investigate the feasibility and effectiveness of serial fecal infusions via colonoscopy in patients with active UC. Subjects with mild-to-moderate UC received three consecutive fecal infusions via colonoscopy. A control population with the same baseline features receiving Infliximab treatment was enrolled. Adverse events and clinical, endoscopic, and microbial outcomes were investigated. Nineteen patients with mildly-to-moderately active UC were enrolled. Clinical response was obtained in six patients at week 2, in eight at week 6, and in nine at week 12. Clinical response was maintained in eight patients at week 24. Endoscopic remission at week 12 was reached in six patients. In the control population, 13/19 patients achieved clinical response at week 6, and 10/19 patients maintained clinical response after 6 months. Microbiota richness was higher in responders compared with the non-responders. Peptostreptococcus, Lactobacillus, and Veillonella were higher in non-responders, while Parabacteroides, Bacteroides, Faecalibacterium, and Akkermansia were higher in responders at all timepoints. Serial FMT infusions appear to be feasible, safe, and effective in UC patients, with a potential role in inducing and maintaining clinical response. Specific bacteria predict the response to FMT.
Protocol for a randomised, placebo-controlled pilot study for assessing feasibility and efficacy of faecal microbiota transplantation in a paediatric ulcerative colitis population: PediFETCh trial. [2022]Label="INTRODUCTION" NlmCategory="BACKGROUND">Ulcerative colitis (UC) is a chronic, relapsing condition characterised by colonic inflammation. Increasing prevalence in early-age diagnosis provides opportunities for additional complications in later life as a result of prolonged exposure to inflammatory and therapeutic insults, necessitating novel avenues for therapeutics which may result in fewer side effects. Faecal microbiota transplantation (FMT) has previously demonstrated potential therapeutic benefit in an adult randomised-controlled trial and several recurrent Clostridium difficile infection studies. This phase Ib pilot will be the first randomised, single-blinded, placebo-controlled trial to assess feasibility and patient outcomes in a paediatric inflammatory bowel disease (IBD) population.
Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. [2022]The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis.
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.
Assessing the efficacy and safety of fecal microbiota transplantation and probiotic VSL#3 for active ulcerative colitis: A systematic review and meta-analysis. [2020]Fecal microbiota transplantation is an effective treatment for many gastrointestinal diseases, such as Clostridium difficile infection and inflammatory bowel disease, especially ulcerative colitis. Changes in colonic microflora may play an important role in the pathogenesis of ulcerative colitis, and improvements in the intestinal microflora may relieve the disease. Fecal bacterial transplants and oral probiotics are becoming important ways to relieve active ulcerative colitis.
Probiotic therapy in the prevention of pouchitis onset: decreased interleukin-1beta, interleukin-8, and interferon-gamma gene expression. [2019]Probiotic therapy has been shown to prevent the onset of pouchitis and to improve the quality of life in ulcerative colitis patients who required ileal pouch anal anastomosis. Pouchitis has been associated with elevated levels of proinflammatory cytokines and chemokines.