Exacerbation of Ulcerative ColitisFMTNCT02033408
Manipulating the Microbiome in IBD by Antibiotics and FMT
A study testing AB (antibiotics) and CS (corticosteroids) Only in people with Exacerbation of Ulcerative Colitis and Ulcerative Colitis, Active Severe, run by Shaare Zedek Medical Center at 12 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Exacerbation of Ulcerative Colitis, Ulcerative Colitis, Active Severe, Crohn's Colitis
- What is being tested?
- AB (antibiotics) and CS (corticosteroids) Only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 12 sitesin 6 countries
- Study dates
- Jan 2014to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Israel6 sites
Soroka Medical Center
Beersheba
Rambam Medical Cener
Haifa
Wolfson Medical Center
Holon
Shaare Zedek Medical Center
Jerusalem, 9103102
Schneider Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Italy2 sites
Università degli Studi di Napoli "Federico II"
Naples
Sapienza University of Rome
Rome
Finland1 site
Hospital for Children and Adolescents Helsinki University Hospital
Helsinki
About this study
Official title: Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial
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.
- Being tested
- AB (antibiotics), CS (corticosteroids) Only
- Keywords
- IBD: Inflammatory Bowel Diseases, CD: Crohn's Disease, UC: Ulcerative Colitis, ASC: Acute Severe Colitis, FMT: Fecal Microbiota Transplantation, PUCAI: Pediatric Ulcerative Colitis Activity Index, Ciprofloxacin, Doxycycline, Gentamycin, amoxicillin, vancomycin, metronidazole,ciprofloxacin
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB (antibiotics)Drug
Also called Ciprofloxacin-Ciprodex®, Doxycycline-Doxylin®, Gentamycin-Gentamicin®, Amoxicillin-Amoxyclav®
- PO Vancomycin 250mgX4/d for 3 weeks
- PO Amoxycillin 50mg/Kg divided by 3 (up to 500mgX3/d) - for 3 weeks
- PO Doxycycline 2mg/kg X2/d (up to 100mgX2/d) - for 3 weeks; OR- For children younger than 8 years: PO Ciprofloxacin 10mg/Kg X2/2 (up to 250mgX2/d) for 3 weeks
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.
CS (corticosteroids) OnlyDrug
Also called Metronidazole-Flagyl®
- methylprednisolone (1.5mg/kg up to 60mg daily in two divided doses)
- PO Metronidazole 5mg/Kg X3/d (up to 250mgX3/d) - for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics in addition to steroids | Experimental | methylprednisolone-1.5mg/kg up to 60mg daily in two divided doses and in addition the following antibiotics:
1. PO Vancomycin 250mg 4 times a day for 3 weeks (children under age 8 125mgX4/d for 3 weeks)
2. PO Amoxycillin 50mg per Kg divided by 3 (up to 500mg 3 times a day) - for 3 weeks
3. PO Metronidazole 5mg per Kg 3 times a day (up to 250mg 3 times a day) - for 3 weeks
4. PO Doxycycline 2mg per kg twice a day (up to 100mg twice a day) - for 3 weeks; OR- For children younger than 7 years: PO Ciprofloxacin 10mg per Kg twice a day (up to 250mg twice a day) for 3 weeks Receives: Drug: AB (antibiotics) |
| Steroids only | Active comparator | methylprednisolone-1.5mg/kg up to 60mg daily in two divided doses Receives: Drug: CS (corticosteroids) Only |
| 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 Receives: Drug: AB (antibiotics); Drug: CS (corticosteroids) Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score
Measured: at day 5 after treatment (compared between the two treatment groups).
Secondary outcomes (9)
Remission rates
defined by PUCAI<10 without the need for second line therapy (anti TNF (Tumor Necrosis Factor), cyclosporine or tacrolimus) or colectomy.
Measured: at days 7, separately at discharge, separately at day 14, and separately at 90 days.
Number of patients with PUCAI<35 points
without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy.
Measured: at day 5
The need for second line therapy or colectomy by discharge
Measured: 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.
Measured: dependency at 1 year
Need for subsequent admission
Measured: by 1 year
Calprotectin levels
Measured: at 5 and 14 days after treatment.
Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL)
Measured: at days 5 and 14 after treatment.
Change in microbiome pattern.
Measured: 3 years from baseline
Rate of C. difficile infection
Measured: at days 5 and 14 after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2018
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exacerbation of Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Turner, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033408
- Sponsor's protocol ID
- ABCS-FMT-01
- Acronym
- FMT
- Status last verified
- Apr 2019
- First submitted
- 3 Dec 2013
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lachman D, Orlanski-Meyer E, Lev-Tzion R, Ledder O, Assa A, Shavit-Brunschwig Z, Yerushalmi B, Aloi M, Griffiths AM, Albenberg L, Bar-Or I, Kolho KL, Shouval DS, Cohen S, Turner D, Atia O. Long-term outcome of pediatric acute severe colitis: A prospective 5-year follow-up of the PRASCO trial. J Pediatr Gastroenterol Nutr. 2025 Mar;80(3):433-439. doi: 10.1002/jpn3.12442. Epub 2024 Dec 24.
PubMed 39718121Turner 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.
PubMed 31833543
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02033408
- Acronym / sponsor ID
- FMT / ABCS-FMT-01
- Keywords
- IBD: Inflammatory Bowel Diseases, CD: Crohn's Disease, UC: Ulcerative Colitis, ASC: Acute Severe Colitis, FMT: Fecal Microbiota Transplantation, PUCAI: Pediatric Ulcerative Colitis Activity Index, Ciprofloxacin, Doxycycline, Gentamycin, amoxicillin, vancomycin, metronidazole,ciprofloxacin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antibiotics in addition to steroids | Experimental | Drug: AB (antibiotics)methylprednisolone-1.5mg/kg up to 60mg daily in two divided doses and in addition the following antibiotics: 1. PO Vancomycin 250mg 4 times a day for 3 weeks (children under age 8 125mgX4/d for 3 weeks) 2. PO Amoxycillin 50mg per Kg divided by 3 (up to 500mg 3 times a day) - for 3 weeks 3. PO Metronidazole 5mg per Kg 3 times a day (up to 250mg 3 times a day) - for 3 weeks 4. PO Doxycycline 2mg per kg twice a day (up to 100mg twice a day) - for 3 weeks; OR- For children younger than 7 years: PO Ciprofloxacin 10mg per Kg twice a day (up to 250mg twice a day) for 3 weeks |
| Steroids only | Active comparator | Drug: CS (corticosteroids) Onlymethylprednisolone-1.5mg/kg up to 60mg daily in two divided doses |
| Open arm | Other | Drug: AB (antibiotics), Drug: CS (corticosteroids) Onlyeither the antibiotics and/or FMT (fecal microbiome transplant) may be administered in a non-randomized, uncontrolled open-label arm to any resistant IBD patients |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB (antibiotics)Also: Ciprofloxacin-Ciprodex®, Doxycycline-Doxylin®, Gentamycin-Gentamicin®, Amoxicillin-Amoxyclav®1. PO Vancomycin 250mgX4/d for 3 weeks 2. PO Amoxycillin 50mg/Kg divided by 3 (up to 500mgX3/d) - for 3 weeks 3. PO Doxycycline 2mg/kg X2/d (up to 100mgX2/d) - for 3 weeks; OR- For children younger than 8 years: PO Ciprofloxacin 10mg/Kg X2/2 (up to 250mgX2/d) for 3 weeks 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. | Drug | Antibiotics in addition to steroids, Open arm |
| CS (corticosteroids) OnlyAlso: Metronidazole-Flagyl®1. methylprednisolone (1.5mg/kg up to 60mg daily in two divided doses) 2. PO Metronidazole 5mg/Kg X3/d (up to 250mgX3/d) - for 3 weeks | Drug | Open arm, Steroids only |
Primary outcome
Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score
Time frame: at day 5 after treatment (compared between the two treatment groups).
9 secondary outcomes
Remission rates
Time frame: at days 7, separately at discharge, separately at day 14, and separately at 90 days.
Number of patients with PUCAI<35 points
Time frame: at day 5
The need for second line therapy or colectomy by discharge
Time frame: by 90 days and at 1 year
Rate of steroid
Time frame: dependency at 1 year
Need for subsequent admission
Time frame: by 1 year
Calprotectin levels
Time frame: at 5 and 14 days after treatment.
Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL)
Time frame: at days 5 and 14 after treatment.
Change in microbiome pattern.
Time frame: 3 years from baseline
Rate of C. difficile infection
Time frame: at days 5 and 14 after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 39718121Lachman D, Orlanski-Meyer E, Lev-Tzion R, Ledder O, Assa A, Shavit-Brunschwig Z, Yerushalmi B, Aloi M, Griffiths AM, Albenberg L, Bar-Or I, Kolho KL, Shouval DS, Cohen S, Turner D, Atia O. Long-term outcome of pediatric acute severe colitis: A prospective 5-year follow-up of the PRASCO trial. J Pediatr Gastroenterol Nutr. 2025 Mar;80(3):433-439. doi: 10.1002/jpn3.12442. Epub 2024 Dec 24.
- Derived from this study: PubMed 31833543Turner 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Turner, MD principal investigator
Shaare Zedek Medical Center
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AB (antibiotics) and CS (corticosteroids) Only in people with Exacerbation of Ulcerative Colitis and Ulcerative Colitis, Active Severe, run by Shaare Zedek Medical Center at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Israel, Italy, Canada, Finland, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score (time frame: at day 5 after treatment (compared between the two treatment groups).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02033408, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.