A Phase 4 interventional study of Ulcerative Colitis Diet and Antibiotic cocktail in Ulcerative Colitis (UC), sponsored by Prof. Arie Levine. Completed at 3 sites in 3 countries. Open to participants aged 8 Years to 19 Years. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Prof. Arie Levine · Phase 4, Interventional, and Treatment
The goal of the study is to evaluate strategies that target the microbiota for the treatment of Ulcerative Colitis , This study will involve a novel diet that the investigators developed , based on the hypothesis that UC involves dysbiosis , underutilzation of certain metabolic pathways and use of pathways that increase risk of inflammation . The investigators have postulated that manipulation of colonic bacterial metabolism with this diet will induce remission in UC without involving additional immune suppression.
Ulcerative colitis is a chronic inflammatory disease primarily involving the colon. It has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors . Recent studies have highlighted several characteristics which may suggest that UC is associated with alterations of the microbiota, defective production of short chain fatty acids and an impaired mucous layer. However at present, no effective therapy targets the microbiota or its interaction with the colonic epithelium. UC in humans is characterized by increased mucosal sulfides and increased sulfate and sulfide reducing bacteria and activation of amino acid metabolism pathways which impair butyrate production, whereas certain dietary patterns in humans and rodent models may induce dysbiosis and favor sulphide reducing bacteria. Further support for targeting the microbiota includes several studies demonstrating that antibiotics might be helpful for severe refractory colitis. Development of treatment strategies that target the microbiota could reduce exposure to immune suppression, and add new therapeutic strategies that do not exist at present.
Though diet has a significant impact on the composition of the microbiota no dietary intervention to date has proven effective for induction of remission. The investigators hypothesized that ulcerative colitis is caused by a series of events involving dysbiosis with sulfate or sulfide reducing bacteria combined with defective production of short chain fatty acids, coupled with a defective mucous layer.
1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Prof. Arie Levine is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria:
Patients will receive a structured novel diet termed the UCD for 6 weeks, and those in remission at week 6 will receive the step down diet for another 6 weeks.
Other: Ulcerative Colitis Diet
This antibiotic treatment will be given as an open label for patients who refuse diet therapy or for patients who show no improvement by week 3 , deteriorate by week 6, or patients who are not in full remission by week 6 will receive a 14 day course of antibiotics as previously described by Kato and colleagues.
Drug: Antibiotic cocktail
we have postulated that a diet that we developed that reduces exposure to dietary ingredients that allow sulfide reducing bacteria to thrive, or that impair the mucous layer, coupled with dietary products that enhance butyrate production, could induce remission in UC without involving additional immune suppression.
We have postulating that antibiotic therapy can alter the microbiota clinically. Controlling the microbiota by antibiotics may allow for control of the disease without immune suppression
Also known as: •Doxycyclin, amoxicillin and metronidazole
Remission rate, defined as a PUCAI less than 10 at week 6.
Time frame: week 6
Mean PUCAI week 6
Time frame: week 6
Mean Calprotectin at week 6
Time frame: week 6
Physicians Global Assessment week 6
Time frame: week 6
Remission week 12, defined as a PUCAI less than 10
Time frame: week 12
Mean PUCAI week 12
Time frame: week 12
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Prof. Arie Levine