Antimicrobial Therapy for Ulcerative Colitis (UC)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 13 Years - 60 Years
Gender All
More 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.

Trial Details

Trial ID:

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.

NCT03986996
Phase

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.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Wolfson Medical Center
Principal Investigator

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
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Group 1 -

triple therapy with amoxicillin, metronidazole and tetracycline twice daily, for 2 weeks.

Experimental: Group 2 -

double therapy with Amoxycillin and Doxycyclin twice daily, for 2 weeks.

Interventions

Drug: - amoxicillin, metronidazole and tetracycline

antibiotics

Drug: - amoxicillin and tetracycline

antibiotics

Contact a Trial Team

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International Sites

The E.Wolfson Medical Center, Holon, Israel

Status

Address

The E.Wolfson Medical Center

Holon, , 58100

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