Butyrate Therapy for Pediatric Ulcerative Colitis
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Children's Hospital Los Angeles
Disqualifiers: Infectious colitis, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.
Will I have to stop taking my current medications?
The trial requires that you stop any ulcerative colitis therapy at least 4 weeks before starting the study medication.
What data supports the effectiveness of the treatment Butyrate for pediatric ulcerative colitis?
Research shows that butyrate, a short-chain fatty acid, can help maintain remission and improve symptoms in ulcerative colitis patients. In one study, patients using butyrate had better outcomes compared to those on standard treatment alone, suggesting it may be a helpful addition to existing therapies.12345
How is butyrate treatment different from other treatments for pediatric ulcerative colitis?
Butyrate treatment is unique because it involves using a naturally occurring short-chain fatty acid that helps maintain gut health and integrity, and it can be administered in various ways, such as orally, intrarectally, or intraperitoneally. This treatment is different from standard therapies as it focuses on increasing butyrate levels in the gut, which can be achieved through dietary changes or direct administration, potentially offering a novel approach to managing ulcerative colitis.15678
Eligibility Criteria
This trial is for children and young adults aged 7-21 with mild to moderate ulcerative colitis. Participants must not be pregnant, should not have received ulcerative colitis therapy within the last 4 weeks, and must not have infectious colitis.Inclusion Criteria
I am between 7 and 21 years old with mild to moderate ulcerative colitis.
Exclusion Criteria
Pregnancy
I haven't had ulcerative colitis treatment in the last 4 weeks.
I have had infectious colitis in the past.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Butyrate enemas are administered once daily for twelve weeks to children with mild to moderate ulcerative colitis
12 weeks
12 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Butyrate (Short Chain Fatty Acid)
Trial OverviewThe study is testing butyrate enemas as a treatment for pediatric ulcerative colitis. Butyrate is a compound produced in the gut that may help manage this condition. The trial aims to assess how effective this approach could be.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: open label intervention armExperimental Treatment1 Intervention
Butyrate enemas will be administered once daily for twelve weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
Children's Hospital Los AngelesLead Sponsor
References
Topical treatment of refractory distal ulcerative colitis with 5-ASA and sodium butyrate. [2019]Nine patients with distal ulcerative colitis refractory to standard therapy were treated with intrarectal instillation of a sodium butyrate solution and 5-ASA. A marked clinical, endoscopical and, to a smaller extent, histological improvement was observed in seven of nine patients. The clinical improvement usually occurred within the second week of therapy, and thus earlier than in previous cases treated with butyrate alone. This preliminary experience suggests that the combined butyrate-5-ASA treatment may prove a useful therapeutic tool in refractory distal ulcerative colitis and possibly increase the effectiveness of the individual therapeutic regimens.
Treatment of distal ulcerative colitis with short-chain fatty acid enemas. A placebo-controlled trial. German-Austrian SCFA Study Group. [2019]Rectal enemas containing a short-chain fatty acid mixture, butyrate alone, or saline placebo were administered to 47 patients with active distal ulcerative colitis. Enemas were instilled twice daily and the patients' condition was evaluated at entry and after four and eight weeks of local therapy. A disease activity index, chosen as the major end point, decreased significantly after all three modes of treatment with no difference among groups. The endoscopic appearance of the mucosa and the histologic degree of inflammation was not different among groups. After eight weeks, fewer colonic segments were affected endoscopically following butyrate than placebo treatment. This study showed trends towards a beneficial effect of topical short-chain fatty acids in active ulcerative colitis, but more patients are needed to demonstrate this effect with sufficient statistical power.
Treatment of refractory distal ulcerative colitis with short chain fatty acid enemas. [2017]To determine the efficacy and safety of short chain fatty acids (SCFA) in the treatment of refractory distal ulcerative colitis (UC).
Combined oral sodium butyrate and mesalazine treatment compared to oral mesalazine alone in ulcerative colitis: randomized, double-blind, placebo-controlled pilot study. [2019]Butyrate represents the main source of energy for colonic epithelial cells; however, its availability/utilization is impaired in ulcerative colitis (UC). In the present randomized, double-blind, placebo-controlled pilot study, the safety and efficacy of colonic targeted oral sodium butyrate tablets, coated with a pH-dependent soluble polymer, have been evaluated in ulcerative colitis. Thirty patients with mild to moderate colitis underwent a six-week course of oral sodium butyrate (4 g/day) plus oral mesalazine (2.4 g/day), (Group A) or of oral mesalazine plus placebo (Group B). Clinical, endoscopic, and histologic data were collected at the beginning and the end of the study. Twenty-five patients completed the study (12 in group A, 13 in group B). No untoward side effects were reported. In group A, seven patients underwent remission and four improved; in Group B the numbers were 5 and 5, respectively. After treatment, all clinical parameters had significantly improved in both treatment arms compared to pretreatment findings. The UC disease activity index (UCDAI) score decreased from 7.27 +/- 2.02 to 2.58 +/- 2.19 (P
The Usefulness of Microencapsulated Sodium Butyrate Add-On Therapy in Maintaining Remission in Patients with Ulcerative Colitis: A Prospective Observational Study. [2020]Butyrate is a short-chain fatty acid that plays a key role in maintaining gut homeostasis as well as the integrity of the intestinal barrier. In the present study, we investigated the effect of oral microencapsulated sodium butyrate (BLM) administration in maintaining remission and improving residual symptoms and inflammatory markers in a population of patients with ulcerative colitis (UC). Forty-two patients with UC in clinical remission were enrolled in the study. Three patients were lost to follow up; 39 patients (18 treated with BLM add-on therapy and 21 with standard mesalamine only) that reached 12 months of follow up were included in the final analysis. Therapeutic success (defined as Mayo partial score ≤ 2 and faecal calprotectin (FC) < 250 µg/g at 12 months of follow up) was achieved in 25 patients (64.1%); 15/18 (83.3%) in BLM group and 10/21 (47.6%) in control group (p = 0.022). Consistently, 13/18 patients (72.2%) receiving BLM improved residual symptoms compared to 5/21 patients (23.8%) in control group (p = 0.003). FC values significantly diminished from the baseline to the end of follow up in patients that received BLM, while FC values remained almost stable in the control group. In conclusion, oral BLM supplementation appears to be a valid add-on therapy in order to maintain remission in patients with UC. Further randomized, placebo-controlled, double-blind clinical trials are needed to validate our results on a larger population or cohort of patients.
Increasing fecal butyrate in ulcerative colitis patients by diet: controlled pilot study. [2019]Topical butyrate has been shown to be effective in the treatment of ulcerative colitis (UC). Butyrate is derived from colonic fermentation of dietary fiber, and our aim was to study whether UC patients could safely increase the fecal butyrate level by dietary means. We enrolled 22 patients with quiescent UC (mean age, 44 years; 45% women; median time from last relapse, 1 year) in a controlled pilot trial lasting 3 months. The patients were instructed to add 60 g oat bran (corresponding to 20 g dietary fiber) to the daily diet, mainly as bread slices. Fecal short-chain fatty acids (SCFAs) including butyrate, disease activity, and gastrointestinal symptoms were recorded every 4 weeks. During the oat bran intervention the fecal butyrate concentration increased by 36% at 4 weeks (from 11 +/- 2 (mean +/- SEM) to 15 +/- 2 micromol/g feces) (p
Butyrate enemas in experimental colitis and protection against large bowel cancer in a rat model. [2019]Butyrate is effective in experimental colitis by increasing transglutaminase activity. Because ulcerative colitis increases the risk of colonic neoplasia, the aim of this study was to investigate whether butyrate treatment reduces mucosal sensitivity to colon cancer development in rats with experimental colitis.
Intraperitoneal administration of butyrate prevents the severity of acetic acid colitis in rats. [2018]Intrarectal infusion of butyrate improves colorectal disorders including ulcerative colitis (UC). However, it is not established whether systemically administered butyrate benefits such patients. The current study aimed at exploring and comparing the potential of intraperitoneally, intrarectally, and orally administered butyrate against acetic acid (AA)-induced UC in rats. Intrarectal administration of 2 ml of 50% AA was done after or without prior treatment of rats for 7 consecutive days with 100 mg/kg sodium butyrate (SB) intraperitoneally, intrarectally, or orally. Rats were sacrificed after 48 h of AA-treatment. Subsequently, colon sections were processed routinely for histopathological examination. We clinically observed diarrhea, loose stools, and hemoccult-positive stools, and histologically, epithelial loss and ulceration, crypt damage, goblet cell depletion, hemorrhage, and mucosal infiltration of inflammatory cells. The changes were significantly reduced by intraperitoneal, intrarectal, or oral butyrate, with intraperitoneal butyrate exhibiting the highest potency. It is concluded that intraperitoneal administration of butyrate abrogates the lesions of AA-induced UC and its potency surpasses that of intrarectal or oral butyrate.