Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— ACHIM2  

Official title:

Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02857257
• Other study ID #: ACHIM2
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Uppsala University
• Contact: Peter Benno, MD, PhD
• Phone: +46 705795554
• Email: Peter.Benno[@]endoskopienheten.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Sweden	Mag-tarm/endoskopienheten Hötorget	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom relief according to irritable bowel syndrome-symptom severity scale (IBS-SSS)		4 weeks
Secondary	Differential bacterial species population as defined by 16S RNA	Description of different bacterial species harboring in fecal samples before and after treatment with ACHIM. Exploratory outcome measure.	4 weeks
Secondary	Normalization of stool consistency as determined by the Bristol stool scale	Normalization as determined by the Bristol stool scale	4 weeks