Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT02345733|
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : June 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis (UC)||Other: Ulcerative Colitis Diet Drug: Antibiotic cocktail||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of a Novel Diet (UC DIET) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study|
|Actual Study Start Date :||September 1, 2015|
|Actual Primary Completion Date :||October 29, 2021|
|Actual Study Completion Date :||October 29, 2021|
Experimental: Ulcerative Colitis Diet
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
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.
Experimental: Antibiotic Treatment
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 postulating that antibiotic therapy can alter the microbiota clinically. Controlling the microbiota by antibiotics may allow for control of the disease without immune suppression
Other Name: •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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345733
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Canada, Nova Scotia|
|IWK Health Centre, Dalhousie University|
|Halifax, Nova Scotia, Canada, 9700|
|The E. Wolfson.Medical Center|
|Holon, Israel, 58100|
|Principal Investigator:||Arie Levine, MD||Wolfson Medical Center|