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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics in addition to steroids | Experimental | methylprednisolone-1.5mg/kg up to 60mg daily in two divided doses and in addition the following antibiotics:
|
|
| Steroids only | Active Comparator | methylprednisolone-1.5mg/kg up to 60mg daily in two divided doses |
|
| Open arm | Other | either the antibiotics and/or FMT (fecal microbiome transplant) may be administered in a non-randomized, uncontrolled open-label arm to any resistant IBD patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB (antibiotics) | Drug |
Patients with known allergy to one of the drugs may be treated with oral Gentamycin (2.5mg/KgX3/d) for 3 weeks instead of the allergenic drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score | at day 5 after treatment (compared between the two treatment groups). |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rates | defined by PUCAI<10 without the need for second line therapy (anti TNF (Tumor Necrosis Factor), cyclosporine or tacrolimus) or colectomy. | at days 7, separately at discharge, separately at day 14, and separately at 90 days. |
| Number of patients with PUCAI<35 points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Turner, MD | Shaare Zedek Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children (SickKids) | Toronto | Canada | ||||
| Hospital for Children and Adolescents Helsinki University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31833543 | Derived | Turner D, Bishai J, Reshef L, Abitbol G, Focht G, Marcus D, Ledder O, Lev-Tzion R, Orlanski-Meyer E, Yerushalmi B, Aloi M, Griffiths AM, Albenberg L, Kolho KL, Assa A, Cohen S, Gophna U, Vlamakis H, Lurz E, Levine A. Antibiotic Cocktail for Pediatric Acute Severe Colitis and the Microbiome: The PRASCO Randomized Controlled Trial. Inflamm Bowel Dis. 2020 Oct 23;26(11):1733-1742. doi: 10.1093/ibd/izz298. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D000305 | Adrenal Cortex Hormones |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
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| CS (corticosteroids) Only | Drug |
|
|
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without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy. |
| at day 5 |
| The need for second line therapy or colectomy by discharge | by 90 days and at 1 year |
| Rate of steroid | defined as a course longer than 3 month with an unsuccessful attempt to wean steroids or cumulative steroid treatment months of 4 months, during the year. | dependency at 1 year |
| Need for subsequent admission | by 1 year |
| Calprotectin levels | at 5 and 14 days after treatment. |
| Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL) | at days 5 and 14 after treatment. |
| Change in microbiome pattern. | 3 years from baseline |
| Rate of C. difficile infection | at days 5 and 14 after treatment. |
| Helsinki |
| Finland |
| Soroka Medical Center | Beersheba | Israel |
| Rambam Medical Cener | Haifa | Israel |
| Wolfson Medical Center | Holon | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Schneider Medical Center | Petah Tikva | Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| Università degli Studi di Napoli "Federico II" | Naples | Italy |
| Sapienza University of Rome | Rome | Italy |
| Univeristy Children's Hospital in Krakow | Krakow | Poland |
| Hospital Regional Universitario Carlos Haya Málaga | Málaga | Spain |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |