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Fecal Transplantation in Patients With IBS

Primary Purpose

IBS - Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

fecal suspension

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age between 18-and 70 years
IBS-SSS (IBS-Symptom Severity Scale) score >175 (175 - 300 represents moderate, > 300 represent severe IBS).
All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or alternating constipation and diarrhoea (IBS-A) with bloating or flatulence as predominant symptoms. Only IBS considered post-infectious after the Bergen Giardia outbreak will be included. The severity of global IBS symptoms has to be either moderate ("cannot be ignored but do not influence daily activities") or severe ("influence daily activities"). A decrease of 50 points on the IBS-SSS has been shown to correlate with improvement in clinical symptoms. All patients will undergo appropriate investigations to exclude organic disease.

Exclusion Criteria:

History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool or antibiotic use within 1 month prior to FMT, immunocompromised patient defined as taking immuno-suppressive medications, history of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
Patients who are scheduled for abdominal surgery, pregnant women or patients taking probiotics or taking antibiotics within 4 weeks prior to installation are also excluded from the protocol.

Sites / Locations

Helse Bergen HF, Haukeland University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fecal transplantation

Arm Description

Duodenal transfer of healthy donor fecal suspension

Outcomes

Primary Outcome Measures

Stool microbiota changes

abundance of major microbial taxa in fecal transplant post transplantation

Secondary Outcome Measures

Global improvement in IBS symptoms

Patient questionnaires IBSS-S

Full Information

NCT ID

NCT03333291

First Posted

October 25, 2017

Last Updated

November 3, 2017

Sponsor

Haukeland University Hospital

Collaborators

Helse Vest

1. Study Identification

Unique Protocol Identification Number

NCT03333291

Brief Title

Fecal Transplantation in Patients With IBS

Official Title

Characterisations of Microbial Community Composition and Kinetics Following Faecal Microbiota Transplantation in Patients WITH IRRITABLE BOWEL SYNDROME

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

October 1, 2016 (Actual)

Primary Completion Date

June 15, 2017 (Actual)

Study Completion Date

June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Haukeland University Hospital

Collaborators

Helse Vest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study will characterize the biology of FMT in the context of IBS prior to wider clinical application of the method. Given the ethical concerns of unknown and long-term adverse effects of FMT therapy, the study will include patients only with moderate to severe symptoms. IBS is a heterogenous disorder and it is important to characterize the patients, and study as homogeneous patient populations as possible. Therefore the study will only include post-infectious IBS patients after the Giardia outbreak.

Detailed Description

Primary aims: Detailed characterisation of donor and recipient microbial community composition (by means of 16S rRNA profiling) and determination of the kinetics of changes following FMT Secondary aims: Determination of interactions of importance to persisting recipient gut microbiota. Evaluate safety of FMT in an IBS population To evaluate the efficacy of FMT in relieving symptoms in selected patients with IBS in an open pilot trial in order to have the possibility to calculate number of patients needed when planning future controlled studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IBS - Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fecal transplantation

Arm Type

Experimental

Arm Description

Duodenal transfer of healthy donor fecal suspension

Intervention Type

Dietary Supplement

Intervention Name(s)

fecal suspension

Intervention Description

helathy donor fecal suspension administered by duodenal scope

Primary Outcome Measure Information:

Title

Stool microbiota changes

Description

abundance of major microbial taxa in fecal transplant post transplantation

Time Frame

up to 28 weeks

Secondary Outcome Measure Information:

Title

Global improvement in IBS symptoms

Description

Patient questionnaires IBSS-S

Time Frame

up to 28 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18-and 70 years IBS-SSS (IBS-Symptom Severity Scale) score >175 (175 - 300 represents moderate, > 300 represent severe IBS). All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or alternating constipation and diarrhoea (IBS-A) with bloating or flatulence as predominant symptoms. Only IBS considered post-infectious after the Bergen Giardia outbreak will be included. The severity of global IBS symptoms has to be either moderate ("cannot be ignored but do not influence daily activities") or severe ("influence daily activities"). A decrease of 50 points on the IBS-SSS has been shown to correlate with improvement in clinical symptoms. All patients will undergo appropriate investigations to exclude organic disease. Exclusion Criteria: History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool or antibiotic use within 1 month prior to FMT, immunocompromised patient defined as taking immuno-suppressive medications, history of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy. Patients who are scheduled for abdominal surgery, pregnant women or patients taking probiotics or taking antibiotics within 4 weeks prior to installation are also excluded from the protocol.

Facility Information:

Facility Name

Helse Bergen HF, Haukeland University Hospital

City

Bergen

ZIP/Postal Code

5021

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34055657

Citation

Mazzawi T, El-Salhy M, Lied GA, Hausken T. The Effects of Fecal Microbiota Transplantation on the Symptoms and the Duodenal Neurogenin 3, Musashi 1, and Enteroendocrine Cells in Patients With Diarrhea-Predominant Irritable Bowel Syndrome. Front Cell Infect Microbiol. 2021 May 12;11:524851. doi: 10.3389/fcimb.2021.524851. eCollection 2021.

Results Reference

derived

PubMed Identifier

31190584

Citation

Mazzawi T, Hausken T, Hov JR, Valeur J, Sangnes DA, El-Salhy M, Gilja OH, Hatlebakk JG, Lied GA. Clinical response to fecal microbiota transplantation in patients with diarrhea-predominant irritable bowel syndrome is associated with normalization of fecal microbiota composition and short-chain fatty acid levels. Scand J Gastroenterol. 2019 Jun;54(6):690-699. doi: 10.1080/00365521.2019.1624815. Epub 2019 Jun 13.

Results Reference

derived

PubMed Identifier

30427836

Citation

Mazzawi T, Lied GA, Sangnes DA, El-Salhy M, Hov JR, Gilja OH, Hatlebakk JG, Hausken T. The kinetics of gut microbial community composition in patients with irritable bowel syndrome following fecal microbiota transplantation. PLoS One. 2018 Nov 14;13(11):e0194904. doi: 10.1371/journal.pone.0194904. eCollection 2018.

Results Reference

derived

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Fecal Transplantation in Patients With IBS

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