Antimicrobial Therapy for Ulcerative Colitis (UC) (UC)
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|ClinicalTrials.gov Identifier: NCT03986996|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: amoxicillin, metronidazole and tetracycline Drug: amoxicillin and tetracycline||Phase 2|
Recent studies suggest that UC is associated with alterations of the microbiota. Further support for targeting the microbiota includes several studies demonstrating that antibiotics might be helpful for severe refractory colitis.
Recently, a triple antibiotic therapy with amoxicillin, metronidazole and tetracycline developed for UC. However, a recent study on the effect of 11 different oral antibiotics on gut bacteria found that seven of them including metronidazole might cause leakiness of the gut.
Based on these recent studies, it would appear that tetracycline and amoxicillin are more likely to cause the beneficial effect, while metronidazole might actually be detrimental. Thus by removing metronidazole the investigators might actually have a better effect both for efficacy and safety.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2 groups with 1:1 randomization|
|Masking Description:||The investigator will be blinded to the study group|
|Official Title:||Antimicrobial Therapy for Ulcerative Colitis : Evaluation of Two Antibiotic Combinations for Refractory Ulcerative Colitis|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||June 2022|
Active Comparator: Group 1 -
triple therapy with amoxicillin, metronidazole and tetracycline twice daily, for 2 weeks.
Drug: amoxicillin, metronidazole and tetracycline
Other Name: Amoxy, Flagyl, Tetracycline hydrochloride
Experimental: Group 2 -
double therapy with Amoxycillin and Doxycyclin twice daily, for 2 weeks.
Drug: amoxicillin and tetracycline
Other Name: Amoxy, Tetracycline hydrochloride
- Efficacy - Clinical Response in group 1 and 2 [ Time Frame: Week 3 ]Response defined as a 3 point drop in SCCAI / 20 point drop in PUCAI or drop in less than 3/20 point but entering clinical remission, defined as a SCCAI score<5 / PUCAI score<10.
- Efficacy - Clinical Response in group 1 and 2 [ Time Frame: Week 6 ]Mean SCCAI / PUCAI
- EFFICACY - Remission [ Time Frame: Week 6 ]SCCAI score<5 / PUCAI score<10.
- EFFICACY - PGA [ Time Frame: Week 6 ]Physicians Global Assessment
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): NCT03986996
|Contact: Michal Yaakov, Ph.D||972-3-5028878||MICHALY@wmc.gov.il|
|The E.Wolfson Medical Center|
|Holon, Israel, 58100|
|Principal Investigator:||Dror Weiner, MD||Wolfson Medical Center|