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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
Sponsor:
Information provided by (Responsible Party):
Prof. Arie Levine, Wolfson Medical Center

Brief Summary:
The Aim of this study is to find a better treatment strategic for UC based on the recent knowledge regarding the microbiota in UC and the good and bad effects of antibiotics in promoting gut health and reduce infection. This study is design to determine whether therapy with two antibiotics - amoxicillin and doxycillin will be better than the current antibiotic treatment including metronidazole and or vancomycin.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: amoxicillin, metronidazole and tetracycline Drug: amoxicillin and tetracycline Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups with 1:1 randomization
Masking: Single (Investigator)
Masking Description: The investigator will be blinded to the study group
Primary Purpose: Treatment
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


Arm Intervention/treatment
Active Comparator: Group 1 -
triple therapy with amoxicillin, metronidazole and tetracycline twice daily, for 2 weeks.
Drug: amoxicillin, metronidazole and tetracycline
antibiotics
Other Name: Amoxy, Flagyl, Tetracycline hydrochloride

Experimental: Group 2 -
double therapy with Amoxycillin and Doxycyclin twice daily, for 2 weeks.
Drug: amoxicillin and tetracycline
antibiotics
Other Name: Amoxy, Tetracycline hydrochloride




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Efficacy - Clinical Response in group 1 and 2 [ Time Frame: Week 6 ]
    Mean SCCAI / PUCAI

  2. EFFICACY - Remission [ Time Frame: Week 6 ]
    SCCAI score<5 / PUCAI score<10.

  3. EFFICACY - PGA [ Time Frame: Week 6 ]
    Physicians Global Assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Established diagnosis of UC, disease confined to the large intestine, involving the rectosigmoid for at least 3 months.
  2. Weight >30 kg
  3. Mild to Moderate active disease, SCCAI of ≥5 and ≤ 10, 10 ≤ PUCAI ≤4.
  4. Refractory to mesalamine 6 weeks, or steroids > 14 days, or immunomodulator 12 weeks or biologics at least 12 weeks therapy.

Exclusion Criteria:

  1. Start of a new biologic in the previous 12 weeks.
  2. Proctitis
  3. Evidence for Clostridium difficile infection.
  4. Any proven current infection such as CMV, positive stool culture or parasite.
  5. Current Extra intestinal manifestation of UC such as active arthritis or PSC.
  6. Immune deficiency (other than drug induced).
  7. Current use of a calcineurin inhibitor
  8. Pregnancy.
  9. Suspected toxic megacolon, guarding on palpation, or signs of peritoneal inflammation
  10. Patients with other IBD unrelated disease such as autoimmune disorders, renal failure, fever or current infection (UTI, strep throat, pneumonia, etc), prior or current neoplasia
  11. Fever >38
  12. Participation in another clinical interventional trial
  13. An active malignant disease or a prior malignancy during the previous 5 years (excluding skin BCC).
  14. Anticipation for antibiotic use within the study period (such as for elective surgery or dental treatment).
  15. Acute severe UC in the past 3 months.
  16. Presence of a pouch or pouchitis.

Information from the National Library of Medicine

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


Contacts
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Contact: Michal Yaakov, Ph.D 972-3-5028878 MICHALY@wmc.gov.il

Locations
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Israel
The E.Wolfson Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center
Investigators
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Principal Investigator: Dror Weiner, MD Wolfson Medical Center

Publications:
Jostins L, Ripke S, Weersma RK, Duerr RH, McGovern DP, Hui KY, Lee JC, Schumm LP, Sharma Y, Anderson CA, Essers J, Mitrovic M, Ning K, Cleynen I, Theatre E, Spain SL, Raychaudhuri S, Goyette P, Wei Z, Abraham C, Achkar JP, Ahmad T, Amininejad L, Ananthakrishnan AN, Andersen V, Andrews JM, Baidoo L, Balschun T, Bampton PA, Bitton A, Boucher G, Brand S, Büning C, Cohain A, Cichon S, D'Amato M, De Jong D, Devaney KL, Dubinsky M, Edwards C, Ellinghaus D, Ferguson LR, Franchimont D, Fransen K, Gearry R, Georges M, Gieger C, Glas J, Haritunians T, Hart A, Hawkey C, Hedl M, Hu X, Karlsen TH, Kupcinskas L, Kugathasan S, Latiano A, Laukens D, Lawrance IC, Lees CW, Louis E, Mahy G, Mansfield J, Morgan AR, Mowat C, Newman W, Palmieri O, Ponsioen CY, Potocnik U, Prescott NJ, Regueiro M, Rotter JI, Russell RK, Sanderson JD, Sans M, Satsangi J, Schreiber S, Simms LA, Sventoraityte J, Targan SR, Taylor KD, Tremelling M, Verspaget HW, De Vos M, Wijmenga C, Wilson DC, Winkelmann J, Xavier RJ, Zeissig S, Zhang B, Zhang CK, Zhao H; International IBD Genetics Consortium (IIBDGC), Silverberg MS, Annese V, Hakonarson H, Brant SR, Radford-Smith G, Mathew CG, Rioux JD, Schadt EE, Daly MJ, Franke A, Parkes M, Vermeire S, Barrett JC, Cho JH. Host-microbe interactions have shaped the genetic architecture of inflammatory bowel disease. Nature. 2012 Nov 1;491(7422):119-24. doi: 10.1038/nature11582.

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Responsible Party: Prof. Arie Levine, Prof, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT03986996     History of Changes
Other Study ID Numbers: AntimicrobialUC
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Prof. Arie Levine, Wolfson Medical Center:
Ulcerative Colitis

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Tetracycline
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action