Donor Selection for Faecal Microbiota Transplantation in Irritable Bowel Syndrome

NCT06171126 | Active Not Recruiting DMC

• 1 other identifier: 630339
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

Five hundred patients are randomized 1:1:1:1 into placebo (own feces), or receiving 90 g fecal transplant from donor A, donor B or donor C. The fecal transplant is administered to the distal duodenum via the working channel of a gastroscope. The patients shall complete 6 questionnaires measuring symptoms, fatigue, quality of life, stool form and diet intake at the baseline and at the end point of the trial and provide a feces sample at the baseline, and at 3, 6 and 12 months after FMT. Dysbiosis and fecal bacterial profile are determined by using 16S rRNA gene PCR DNA amplification/probe hybridization covering regions V3-V9.

Conditions

Irritable Bowel Syndrome

Keywords

Fecal microbiota transplantation; Intestinal microbiota; Donor; Dysbiosis; Abdominal symptom; Fatigue; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change in IBS-Severity Scoring System total score

  Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) is a visual analogue scale questionnaire with a total score between 0 and 500 points, with "0" meaning no symptom and higher scores meaning increasing severity. A decrease in total score by ≥50 points is considered as a meaningful response.

  12 months after FMT

Secondary Outcomes (1)

• Change in dysbiosis index

  12 months after FMT

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Own faeces instilled to the small intestine during gastroscopy

Dietary Supplement: Placebo

Arm A

EXPERIMENTAL

90g of faeces from Donor A is instilled to the small intestine during gastroscopy

Dietary Supplement: Faeces from donor A

Arm B

EXPERIMENTAL

90g of faeces from Donor B is instilled to the small intestine during gastroscopy

Dietary Supplement: Faeces from donor B

Arm C

EXPERIMENTAL

90g of faeces from Donor C is instilled to the small intestine during gastroscopy

Dietary Supplement: Faeces from donor C

Interventions

Placebo DIETARY_SUPPLEMENT

By gastroscopy

Placebo

Faeces from donor A DIETARY_SUPPLEMENT

By gastroscopy

Arm A

Faeces from donor B DIETARY_SUPPLEMENT

By gastroscopy

Arm B

Faeces from donor C DIETARY_SUPPLEMENT

By gastroscopy

Arm C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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-SSS questionnaire

You may not qualify if:

• Pregnant, women planning pregnancy or lactating women.
• The use of antibiotics or probiotics within 1
• month prior to FMT.
• Having undergone any abdominal surgery, with
• the exception of appendectomy, cholecystectomy,
• caesarean section and hysterectomy.
• Previous treatment with FMT.
• Immunocompromised patients including those being
• treated by immunosuppressive medications.
• Patients with co-morbidity such as kidney failure,
• diabetes or chronic heart disease.
• Patients with serious psychiatric disorders
• or alcohol or drug abuse.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (3)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

Location

Helse Møre og Romsdal HF

Ålesund, Norway

Location

Diakonhjemmet

Oslo, Norway

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dysbiosis; Fatigue

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jan G Hatlebakk, PhD

  Haukeland University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After completion of the study

Locations

NO (3)