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Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome (ACHIM2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Uppsala University
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Per Hellström, Uppsala University
ClinicalTrials.gov Identifier:
NCT02857257
First received: July 26, 2016
Last updated: August 4, 2016
Last verified: August 2016
  Purpose
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).

Condition Intervention Phase
Irritable Bowel Syndrome
Biological: ACHIM
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Symptom relief according to irritable bowel syndrome-symptom severity scale (IBS-SSS) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Differential bacterial species population as defined by 16S RNA [ Time Frame: 4 weeks ]
    Description of different bacterial species harboring in fecal samples before and after treatment with ACHIM. Exploratory outcome measure.

  • Normalization of stool consistency as determined by the Bristol stool scale [ Time Frame: 4 weeks ]
    Normalization as determined by the Bristol stool scale


Estimated Enrollment: 50
Study Start Date: January 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
Only one treatment arm. Patients are allocated under disease condition and later treated with ACHIM. The post-treatment disease progression is monitored.
Biological: ACHIM
After an observation period of 4 weeks patients with IBS-D will be treated with ACHIM
Other Name: Anaerobic cultured human intestinal microbiota

Detailed Description:

Diarrhea-dominated irritable bowel syndrome (IBS-D) is studied in subjects by treatment with an anaerobic human intestinal microbiota cultured for 15 years and quality controlled with a specified content of bacterial species regularly over the years. Inclusion criteria is: Diarrheal disease since at least 4 weeks, 18-80 years of age, previously unsuccessful treatment with no symptomatic relief of antidiarrheals or resins, and signed informed consent.

Primary outcome was irritable bowel syndrome-symptom severity scale (IBS-SSS). Secondary outcome was Bristol stool scale (BSS).

Secondary outcome: Changes in fecal microflora distribution and multiplicity as shown by the 16S ribosomal ribonucleic acid (rRNA) analysis of feces.

Once eligible for the study, patients were monitored for a run-in period of one week with the IBS-SSS and the BSS plus fecal samples for analysis of bacterial species using the bacterial specific 16S rRNA differentiation.

Then, the anaerobic cultured human intestinal microflora (ACHIM) was given twice with an interval of 1 week. Thereafter, patients were further monitored over 4 weeks as regards IBS-SSS and BSS. Another feces sample was also collected for bacterial 16S rRNA analysis to evaluate the microbiota diversity.

The study will be evaluated using eligible subjects as their own controls by means of Wilcoxon's matched-pairs test, alternatively t-test for matched pairs.

Power analysis show that 40 subjects are needed to study in order to achieve a power of 80%.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IBS according to the Rome III criteria

Exclusion Criteria:

  • Pregnancy
  • Antibiotic and probiotics within 8 weeks before inclusion
  • Unable to give informed consent
  • Immunodeficiency (drug- och disease-related)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02857257

Contacts
Contact: Peter Benno, MD, PhD +46 705795554 Peter.Benno@endoskopienheten.se
Contact: Per Hellström, MD, PhD +46 70 3727423 Per.Hellstrom@medsci.uu.se

Locations
Sweden
Mag-tarm/endoskopienheten Hötorget Recruiting
Stockholm, Sweden, 11157
Contact: Peter Benno, MD, PhD    +46 7055795554    Peter.Benno@endoskopienheten.se   
Contact: Per Hellström, MD; PhD    +46 70 3727423    Per.Hellstrom@medsci.uu.se   
Sponsors and Collaborators
Uppsala University
Karolinska Institutet
Investigators
Study Director: Per Hellström, MD, PhD Uppsala University
  More Information

Publications:
Responsible Party: Per Hellström, Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT02857257     History of Changes
Other Study ID Numbers: ACHIM2
Study First Received: July 26, 2016
Last Updated: August 4, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Uppsala University:
IBS
Microbiota

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on March 29, 2017