Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||13 Years - 60 Years|
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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Wolfson Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Dror Weiner, MD|
|Principal Investigator Affiliation||Wolfson Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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. Antibiotics may work by reducing pathobionts, by causing niche expansion of beneficial bacteria , and may harm if they do not reduce pathobionts or reduce beneficial commensals Recently, a triple antibiotic therapy with amoxicillin, metronidazole and tetracycline was 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 lbacterial translocation . Anaerobes are critical for butyrate production. . 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.
Active Comparator: Group 1 -Amoxycillin Doxycyclin and metronidazole
triple therapy with amoxicillin, metronidazole and tetracycline twice daily, for 2 weeks.
Experimental: Group 2 -Amoxycillin and Doxycyclin
double therapy with Amoxycillin and Doxycyclin twice daily, for 2 weeks.
Drug: - amoxicillin, metronidazole and doxycycline
antibiotics: Patient weight 30-50 kg Patient weight > 50 kg Tetracycline 50 mg X 2 Day X 2 weeks 100 mg X 2 Day X 2 weeks Amoxicillin 750 mg X 2 Day X 2 weeks 750 mg X 2 Day X 2 weeks Metronidazole 250 mg X 2 Day X 2 weeks 375 mg X 2 Day X 2 weeks
Drug: - amoxicillin and doxycyclin
antibiotics: Patient weight 30-50 kg Patient weight > 50 kg Tetracycline 50 mg X 2 Day X 2 weeks 100 mg X 2 Day X 2 weeks Amoxicillin 750 mg X 2 Day X 2 weeks 750 mg X 2 Day X 2 weeks
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.