NCT02857257

Brief Summary

Patients with irritable bowel syndrome (IBS) are treated with microbiota from a human intestinal anaerobic sample cultured for decades. Patients are recruited consecutively with symptoms of IBS and serve as their own controls. After an observation time of 4 weeks, patients are recruited for a 1-week run-in and then given the cultured fecal microbiota by the duodenal route via gastroscopy. Two treatments are given within a 1-week interval. Assessment of symptoms are made before and 4 weeks after the last treatment (at 6 weeks). Additionally, fecal samples are collected for bacterial 16S ribosomal ribonucleic acid (rRNA) analysis and bacterial functional parameters (microflora-associated characteristics).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

3.9 years

First QC Date

July 26, 2016

Last Update Submit

August 7, 2018

Conditions

Irritable Bowel Syndrome

Keywords

IBSMicrobiota

Outcome Measures

Primary Outcomes (1)

  • Symptom relief according to irritable bowel syndrome-symptom severity scale (IBS-SSS)

    4 weeks

Secondary Outcomes (2)

  • Differential bacterial species population as defined by 16S RNA

    4 weeks

  • Normalization of stool consistency as determined by the Bristol stool scale

    4 weeks

Study Arms (1)

Treatment arm

EXPERIMENTAL

Only one treatment arm. Patients are allocated under disease condition and later treated with ACHIM. The post-treatment disease progression is monitored.

Biological: ACHIM

Interventions

ACHIMBIOLOGICAL

After an observation period of 4 weeks patients with IBS-D will be treated with ACHIM

Also known as: Anaerobic cultured human intestinal microbiota
Treatment arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IBS according to the Rome III criteria

You may not qualify if:

  • Pregnancy
  • Unable to give informed consent
  • Immunodeficiency (drug- och disease-related)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mag-tarm/endoskopienheten Hötorget

Stockholm, 11157, Sweden

RECRUITING

Related Publications (4)

  • Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.

    PMID: 9146781RESULT

  • Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.

    PMID: 9299672RESULT

  • Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.

    PMID: 24018052RESULT

  • Benno P, Norin E, Midtvedt T, Hellstrom PM. Therapeutic potential of an anaerobic cultured human intestinal microbiota, ACHIM, for treatment of IBS. Best Pract Res Clin Gastroenterol. 2019 Jun-Aug;40-41:101607. doi: 10.1016/j.bpg.2019.03.003. Epub 2019 Apr 29.

    PMID: 31594647DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Per Hellström, MD, PhD

    Uppsala University

    STUDY DIRECTOR

Central Study Contacts

Peter Benno, MD, PhD

CONTACT

+46 705795554Peter.Benno@endoskopienheten.se

Per Hellström, MD, PhD

CONTACT

+46 70 3727423Per.Hellstrom@medsci.uu.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 5, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)