|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
6 June 2022 |
|
Main ID: |
NCT03986996 |
|
Date of registration:
|
04/06/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Antimicrobial Therapy for Ulcerative Colitis (UC)
UC |
|
Scientific title:
|
Antimicrobial Therapy for Ulcerative Colitis : Evaluation of Two Antibiotic Combinations for Refractory Ulcerative Colitis |
|
Date of first enrolment:
|
July 25, 2019 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT03986996 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Israel
| | | | | | | |
|
Contacts
|
|
Name:
|
Dror Weiner, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Wolfson Medical Center |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
13 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative Colitis
|
|
Intervention(s)
|
|
Drug: amoxicillin and doxycyclin
|
|
Drug: amoxicillin, metronidazole and doxycycline
|
|
Primary Outcome(s)
|
|
Efficacy - Clinical Response in group 1 and 2 or Clinical Remission
[Time Frame: Week 3]
|
|
Secondary Outcome(s)
|
|
Efficacy - Clinical Response in group 1 and 2
[Time Frame: Week 6]
|
|
EFFICACY - Corticosteroid free remission
[Time Frame: Week 12]
|
|
EFFICACY - Remission
[Time Frame: Week 6]
|
|
EFFICACY - Decrease in endoscopic disease activity
[Time Frame: Week 12]
|
|
EFFICACY - Corticosteroid free remission
[Time Frame: Week 6]
|
|
EFFICACY - PGA
[Time Frame: Week 6]
|
|
Secondary ID(s)
|
|
AntimicrobialUC
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|