CompletedNot Applicable

Manipulating the Microbiome in IBD by Antibiotics and FMT

Canada, Finland, Israel28 participantsStarted 2014-01

Plain-language summary

the etiology of Inflammatory Bowel Diseases (IBD) is closely associated with the gut microbiome. The results of previous studies on the effectiveness of antibiotics and fecal macrobiota transplantation (FMT) are contradicting. Aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe colitis in an addition to standard corticosteroid therapy (UC and isolated "UC-like" Crohn's colitis). The secondary aim is to assess the outcome of FMT in those not responding to five days of therapy (in either arm). As an exploratory aim, any IBD patient with a resistant disease to at least two immunosuppressive medications, may be treated with either interventions.

Who can participate

Age range

2 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children over the age the 2 years and adults of all ages with established diagnosis of UC using standard criteria (26, 27). * Admission for IV steroid therapy * PUCAI of at least 65 points at admission (i.e. severe attack) * PUCAI\>45 at enrollment * Ability to swallow antibiotics (pills or syrup) Exclusion Criteria: * Change in dose or intervals of anti-TNF within the past 2 months prior to admission. * Disease confined to the rectum (Proctitis). * Antibiotic use in the past 4 weeks. * Any known erosive inflammation anywhere in the small bowel or esophagus. * Any proven infection such as positive stool culture, parasite or C. difficile, urinary tract infection, cellulitis, abscess, pneumonia, line-infections etc. * Fever \>38.5, or \>38.0c thought to be unrelated to the inflammatory process of active UC. * The probable need for second line medical therapy (infliximab, cyclosporine, tacrolimus) or colectomy within 5 days of enrollment, as judged by the caring physician. * Known allergy to more than one antibiotic regimen from the list below. * Pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score

Timeframe: at day 5 after treatment (compared between the two treatment groups).

Trial details

NCT IDNCT02033408

SponsorShaare Zedek Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

View on ClinicalTrials.gov More Exacerbation of Ulcerative Colitis trials