NCT04236843

Brief Summary

Two hundrad patients are randomized to either 90 g transplant, 90 g transplant twice with 1week interval into the distal small intestine via working channel of a gastroscope, or to 90 g transplant into the coecum of the colon via working channel of a colonoscope. The patients shall complete 5 questionnaires measuring symptoms, fatigue and quality of life and collect a feces sample at the baseline, and at 3, 6 and 12 months after FMT. Dysbiosis and fecal bacterial are determined by using 16S rRNA gene.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

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

January 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2.1 years

First QC Date

January 15, 2020

Last Update Submit

August 17, 2023

Conditions

Irritable Bowel Syndrome

Keywords

Fecal microbiota transplantationIntestinal microbiotaDonorDysbiosisAbdominal symptomFatigueQuality of life

Outcome Measures

Primary Outcomes (1)

  • Change in IBS-SSS total score

    Irritable bowel syndrome-symptom severity score (IBS-SSS) is a visual analogue scale questionnaire with a maximum score of 500 points. A decrease in total score by ≥50 points is considered as a response.

    12 months after FMT

Secondary Outcomes (1)

  • Change in the Dysbiosis index

    12 months after FMT

Study Arms (3)

Smal intestine once

ACTIVE COMPARATOR

90-g fecal transplant given into the small intestine once.

Dietary Supplement: Feces

Small intestine twice

ACTIVE COMPARATOR

90-g fecal transplant given into the small intestine twice with 1 week interval.

Dietary Supplement: Feces

Large intestine once

ACTIVE COMPARATOR

90-g fecal transplant given into the large intestine once.

Dietary Supplement: Feces

Interventions

FecesDIETARY_SUPPLEMENT

Feces from healthy donor

Large intestine onceSmal intestine onceSmall intestine twice

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who fulfil Rome IV criteria for the diagnosis of IBS.
  • Patients were investigated to exclude other gastrointestinal organic cause(s).
  • Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS).

You may not qualify if:

  • Pregnant or lactating women.
  • The use of antibiotics or probiotics within 1 month prior to FMT.
  • Immunocompromised patients defined as those treated by immune- suppressive medications.
  • Patients with co-morbidity such as kidney failure or chronic heart disease.
  • System disease such as diabetes.
  • Patients with serious psychiatric disorders or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helse Fonna

Haugesund, 5504, Norway

Location

Related Publications (4)

  • El-Salhy M, Gilja OH, Hatlebakk JG. Factors underlying the long-term efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome. Microbes Infect. 2024 Nov-Dec;26(8):105372. doi: 10.1016/j.micinf.2024.105372. Epub 2024 Jun 4.

    PMID: 38843950DERIVED

  • El-Salhy M, Hatlebakk JG. Factors Underlying the Difference in Response to Fecal Microbiota Transplantation Between IBS Patients with Severe and Moderate Symptoms. Dig Dis Sci. 2024 Apr;69(4):1336-1344. doi: 10.1007/s10620-024-08369-x. Epub 2024 Mar 6.

    PMID: 38446309DERIVED

  • El-Salhy M, Gilja OH, Hatlebakk JG. Increasing the transplant dose and repeating faecal microbiota transplantation results in the responses of male patients with IBS reaching those of females. Scand J Gastroenterol. 2024 Apr;59(4):391-400. doi: 10.1080/00365521.2023.2292479. Epub 2023 Dec 12.

    PMID: 38084725DERIVED

  • El-Salhy M, Gilja OH, Hatlebakk JG. Factors affecting the outcome of fecal microbiota transplantation for patients with irritable bowel syndrome. Neurogastroenterol Motil. 2024 Jan;36(1):e14641. doi: 10.1111/nmo.14641. Epub 2023 Jul 10.

    PMID: 37427566DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeDysbiosisFatigue

Interventions

Defecation

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Magdy El-Salhy, MD,PhD

    Helse Fonna

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 22, 2020

Study Start

February 3, 2020

Primary Completion

March 25, 2022

Study Completion

March 25, 2022

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

NO(1)