Ulcerative ColitisPhase 2NCT03273465

Fecal Microbiota Transplantation in Ulcerative Colitis

A Phase 2 study testing Fecal transplantation in people with Ulcerative Colitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: Fecal transplantation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteIsrael
Study dates: 27 Mar 2017to Apr 2021
Phase: Phase 2
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 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT.
Ability to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool.
Ability to swallow oral medications.

Who cannot join

Severe, uncontrolled ulcerative colitis.
Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Delayed gastric emptying syndrome
Known chronic aspiration
Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
Pregnant and breast-feeding women
Participants who are unable to swallow pills.

Trial locations and contacts

1 site in 1 country.

Ilan Youngster, Dr. contact

972-50-6301191

yongsteri@asaf.health.gov.il

Israel1 site, 1 recruiting

Assaf-HarofehMC
Tsrifin, 70300
Ilan Youngster, Dr., 972-50-6301191, youngsteri@asaf.health.gov.il
Recruiting

Other trials in Israel

About this study

Official title: Fecal Microbiota Transplantation in Newly Diagnosed Patients With Ulcerative Colitis - a Double Blind, Placebo-Controlled Trial

This is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed adult patients with mild-moderate UC.

The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation,in newly diagnosed adult patients with mild-moderate UC.

All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical Center, under GMP conditions.

Conditions: Ulcerative Colitis
Being tested: Fecal transplantation
Keywords: IBD, Colitis, fecal, FMT, microbiota, transplantation
Medical subject headings: Colitis, Ulcerative, Colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fecal transplantationOther
Fecal transplantation administered orally via frozen capsules.

Study groups in NCT03273465
Study group	Role	What they receive
Fecal transplantation	Experimental	Fecal transplantation of feces from healthy donor via capsules. Oral application. Receives: Other: Fecal transplantation
Placebo	Placebo comparator	Placebo capsules Receives: Other: Fecal transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

UC remission
UC remission at week 12 defined as a Simple Clinical Colitis Activity Index<3
Measured: 12 weeks

Secondary outcomes (6)

Improvement in UC symptoms
defined as improvement in SCCAI
Measured: 12 weeks
Improvement in UC endoscopic score
Mayo-score
Measured: 12 weeks, 6 months and 12 months
markers of inflammation
Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin
Measured: 12 weeks, 6 months and 12 months
change in gut microbiome
Diversity and variability of gut microbiome
Measured: 12 weeks, 6 and 12 months.
use of treatments for UC
such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists.
Measured: 6+12 months
Extra-intestinal disease manifestations
Extra-intestinal disease manifestations
Measured: 6 and 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 2017Apr 2021

First posted6 Sep 2017
Study start27 Mar 2017
Primary completionApr 2020 (estimated)
Study completionApr 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a placebo-controlled, double blinded interventional study evaluating oral, fecal microbiota transplantation, administered in patients with mild-moderate UC.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03273465
Sponsor's protocol ID: 0268-16-ASF
Status last verified: Sep 2017
First submitted: 4 Sep 2017
Last updated: 6 Sep 2017
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt TJ. Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review. Ann Intern Med. 2015 May 5;162(9):630-8. doi: 10.7326/M14-2693.
PubMed 25938992
Li SS, Zhu A, Benes V, Costea PI, Hercog R, Hildebrand F, Huerta-Cepas J, Nieuwdorp M, Salojarvi J, Voigt AY, Zeller G, Sunagawa S, de Vos WM, Bork P. Durable coexistence of donor and recipient strains after fecal microbiota transplantation. Science. 2016 Apr 29;352(6285):586-9. doi: 10.1126/science.aad8852.
PubMed 27126044
Rossen NG, MacDonald JK, de Vries EM, D'Haens GR, de Vos WM, Zoetendal EG, Ponsioen CY. Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. World J Gastroenterol. 2015 May 7;21(17):5359-71. doi: 10.3748/wjg.v21.i17.5359.
PubMed 25954111
Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22.
PubMed 27329806
Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt T. Fecal Microbiota Transplantation for Clostridium Difficile Infection: A Systematic Review of the Evidence [Internet]. Washington (DC): Department of Veterans Affairs (US); 2014 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK299000/
PubMed 26042318
Scaldaferri F, Pecere S, Petito V, Zambrano D, Fiore L, Lopetuso LR, Schiavoni E, Bruno G, Gerardi V, Laterza L, Pizzoferrato M, Ianiro G, Stojanovic J, Poscia A, Papa A, Paroni Sterbini F, Sanguinetti M, Masucci L, Cammarota G, Gasbarrini A. Efficacy and Mechanisms of Action of Fecal Microbiota Transplantation in Ulcerative Colitis: Pitfalls and Promises From a First Meta-Analysis. Transplant Proc. 2016 Mar;48(2):402-7. doi: 10.1016/j.transproceed.2015.12.040.
PubMed 27109966
Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
PubMed 25857665
Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.
PubMed 25836986
Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875.
PubMed 25322359
Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3.
PubMed 24890442

Want to know more?

Ilan Youngster, Dr.

972-50-6301191

yongsteri@asaf.health.gov.il

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fecal Microbiota Transplantation in Newly Diagnosed Patients With Ulcerative Colitis - a Double Blind, Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT03273465
Acronym / sponsor ID: 0268-16-ASF
Conditions: Ulcerative Colitis
Keywords: IBD, Colitis, fecal, FMT, microbiota, transplantation
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Assaf-Harofeh Medical CenterOther government
Study start: 27 Mar 2017 (actual)
Primary completion: Apr 2020 (estimated)
Study completion: Apr 2021 (estimated)
First posted: 6 Sep 2017 (actual)
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.

This is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed adult patients with mild-moderate UC.

The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation,in newly diagnosed adult patients with mild-moderate UC.

All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical Center, under GMP conditions.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: This is a placebo-controlled, double blinded interventional study evaluating oral, fecal microbiota transplantation, administered in patients with mild-moderate UC.

Arm	Type	Receives
Fecal transplantation	Experimental	Other: Fecal transplantationFecal transplantation of feces from healthy donor via capsules. Oral application.
Placebo	Placebo comparator	Other: Fecal transplantationPlacebo capsules

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT.
Ability to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool.
Ability to swallow oral medications.

Key exclusion criteria (7 listed)

Severe, uncontrolled ulcerative colitis.
Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Delayed gastric emptying syndrome
Known chronic aspiration
Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)

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
Fecal transplantationFecal transplantation administered orally via frozen capsules.	Other	Fecal transplantation, Placebo

Primary outcome

UC remission
Time frame: 12 weeks
UC remission at week 12 defined as a Simple Clinical Colitis Activity Index<3

6 secondary outcomes

Improvement in UC symptoms
Time frame: 12 weeks
Improvement in UC endoscopic score
Time frame: 12 weeks, 6 months and 12 months
markers of inflammation
Time frame: 12 weeks, 6 months and 12 months
change in gut microbiome
Time frame: 12 weeks, 6 and 12 months.
use of treatments for UC
Time frame: 6+12 months
Extra-intestinal disease manifestations
Time frame: 6 and 12 month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
Background: PubMed 25938992Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt TJ. Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review. Ann Intern Med. 2015 May 5;162(9):630-8. doi: 10.7326/M14-2693.
Background: PubMed 27126044Li SS, Zhu A, Benes V, Costea PI, Hercog R, Hildebrand F, Huerta-Cepas J, Nieuwdorp M, Salojarvi J, Voigt AY, Zeller G, Sunagawa S, de Vos WM, Bork P. Durable coexistence of donor and recipient strains after fecal microbiota transplantation. Science. 2016 Apr 29;352(6285):586-9. doi: 10.1126/science.aad8852.
Background: PubMed 25954111Rossen NG, MacDonald JK, de Vries EM, D'Haens GR, de Vos WM, Zoetendal EG, Ponsioen CY. Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. World J Gastroenterol. 2015 May 7;21(17):5359-71. doi: 10.3748/wjg.v21.i17.5359.
Background: PubMed 27329806Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22.
Background: PubMed 26042318Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt T. Fecal Microbiota Transplantation for Clostridium Difficile Infection: A Systematic Review of the Evidence [Internet]. Washington (DC): Department of Veterans Affairs (US); 2014 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK299000/
Background: PubMed 27109966Scaldaferri F, Pecere S, Petito V, Zambrano D, Fiore L, Lopetuso LR, Schiavoni E, Bruno G, Gerardi V, Laterza L, Pizzoferrato M, Ianiro G, Stojanovic J, Poscia A, Papa A, Paroni Sterbini F, Sanguinetti M, Masucci L, Cammarota G, Gasbarrini A. Efficacy and Mechanisms of Action of Fecal Microbiota Transplantation in Ulcerative Colitis: Pitfalls and Promises From a First Meta-Analysis. Transplant Proc. 2016 Mar;48(2):402-7. doi: 10.1016/j.transproceed.2015.12.040.
Background: PubMed 25857665Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
Background: PubMed 25836986Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.
Background: PubMed 25322359Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875.
Background: PubMed 24890442Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3.
Individual participant dataSharing planned: Undecided

Related trials for Ulcerative Colitis

Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
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RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
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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.

Ilan Youngster, Dr. contact

972-50-6301191

yongsteri@asaf.health.gov.il

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fecal transplantation in people with Ulcerative Colitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.

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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ilan Youngster, Dr. (972-50-6301191, yongsteri@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

UC remission (time frame: 12 weeks). 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 NCT03273465, which also lists 10 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 6 Sep 2017.