NCT03538366

Brief Summary

Patients with chronic pouchitis are treated with fecal transplant from several unrelated, healthy donors. The treatment consists of enemas of 100 mL fecal suspension, applied for 14 consecutive days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

12 months

First QC Date

May 11, 2018

Last Update Submit

December 17, 2019

Conditions

Ulcerative ColitisPouchitis

Keywords

Ulcerative ColitisInflammatory bowel diseasePouchitisFecal microbiota transplantFecal microbiota treatment

Outcome Measures

Primary Outcomes (1)

  • Cure 30 days following FMT treatment

    PDAI \< 7

    30 days

Secondary Outcomes (6)

  • Changes of the microbiota

    30 days

  • Clinical response 30 days after FMT treatment

    30 days

  • Histological remission following PDAI

    30 days

  • Improvement of pouch function

    30 days

  • Improvement of quality of life

    30 days

  • +1 more secondary outcomes

Study Arms (1)

Donor FMT

EXPERIMENTAL

Fecal transplant from unrelated, healthy volunteers

Other: Donor FMT

Interventions

Donor FMTOTHER

Fecal transplant from unrelated, healthy donors using enemas

Donor FMT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • minimum 18 years old, pouch \> 1 year
  • at least three pouchitis events in the past year
  • antibiotic treatment for pouchitis at least one time in the past year

You may not qualify if:

  • immunosuppression, pregnancy, detection of specific pathogens in stool

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit, Department of Gastrointestinal Surgery

Aalborg, 9000, Denmark

Location

Related Publications (10)

  • Becker JM. Surgical therapy for ulcerative colitis and Crohn's disease. Gastroenterol Clin North Am. 1999 Jun;28(2):371-90, viii-ix. doi: 10.1016/s0889-8553(05)70061-3.

    PMID: 10372273BACKGROUND

  • Onaitis MW, Mantyh C. Ileal pouch-anal anastomosis for ulcerative colitis and familial adenomatous polyposis: historical development and current status. Ann Surg. 2003 Dec;238(6 Suppl):S42-8. doi: 10.1097/01.sla.0000098115.90865.16.

    PMID: 14703744BACKGROUND

  • Lovegrove RE, Tilney HS, Heriot AG, von Roon AC, Athanasiou T, Church J, Fazio VW, Tekkis PP. A comparison of adverse events and functional outcomes after restorative proctocolectomy for familial adenomatous polyposis and ulcerative colitis. Dis Colon Rectum. 2006 Sep;49(9):1293-306. doi: 10.1007/s10350-006-0608-0.

    PMID: 16830218BACKGROUND

  • Sandborn WJ. Pouchitis following ileal pouch-anal anastomosis: definition, pathogenesis, and treatment. Gastroenterology. 1994 Dec;107(6):1856-60. doi: 10.1016/0016-5085(94)90832-x. No abstract available.

    PMID: 7958702BACKGROUND

  • Shen B. Diagnosis and treatment of patients with pouchitis. Drugs. 2003;63(5):453-61. doi: 10.2165/00003495-200363050-00002.

    PMID: 12600225BACKGROUND

  • Shen B, Achkar JP, Lashner BA, Ormsby AH, Remzi FH, Brzezinski A, Bevins CL, Bambrick ML, Seidner DL, Fazio VW. A randomized clinical trial of ciprofloxacin and metronidazole to treat acute pouchitis. Inflamm Bowel Dis. 2001 Nov;7(4):301-5. doi: 10.1097/00054725-200111000-00004.

    PMID: 11720319BACKGROUND

  • Sandborn WJ, Pardi DS. Clinical management of pouchitis. Gastroenterology. 2004 Dec;127(6):1809-14. doi: 10.1053/j.gastro.2004.10.011. No abstract available.

    PMID: 15578518BACKGROUND

  • Khan KJ, Ullman TA, Ford AC, Abreu MT, Abadir A, Marshall JK, Talley NJ, Moayyedi P. Antibiotic therapy in inflammatory bowel disease: a systematic review and meta-analysis. Am J Gastroenterol. 2011 Apr;106(4):661-73. doi: 10.1038/ajg.2011.72. Epub 2011 Mar 15.

    PMID: 21407187BACKGROUND

  • Tulchinsky H, Hawley PR, Nicholls J. Long-term failure after restorative proctocolectomy for ulcerative colitis. Ann Surg. 2003 Aug;238(2):229-34. doi: 10.1097/01.sla.0000082121.84763.4c.

    PMID: 12894016BACKGROUND

  • Angriman I, Scarpa M, Castagliuolo I. Relationship between pouch microbiota and pouchitis following restorative proctocolectomy for ulcerative colitis. World J Gastroenterol. 2014 Aug 7;20(29):9665-74. doi: 10.3748/wjg.v20.i29.9665.

    PMID: 25110406BACKGROUND

MeSH Terms

Conditions

Colitis, UlcerativePouchitisInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal DiseasesIleitisEnteritisIleal Diseases

Study Officials

  • Ole Thorlacius-Ussing, Professor

    Aalborg University Hospital, Aalborg University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc, Professor of Surgery

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 29, 2018

Study Start

May 15, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations

DK(1)