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Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Active
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Fecal microbiota transplantation (FMT)
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring fecal microbiota therapy, bacteriotherapy, stool transplant, IBS, FMT, gut microbiota brain axis, functional disorder, IBS-M, IBS-D, IBS-C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion

  • Diagnosed with IBS in the primary or secondary health care service
  • Aged 18-65 years with IBS defined by the Rome IV criteria:
  • Moderate to severe IBS symptoms, as defined by a score of ≥175 on the IBS-SSS
  • All participants >50 years: Colonoscopy within the last 5 years prior to study entry including negative mucosal biopsy for microscopic colitis in participants subtyped as IBS-D

Exclusion

  • Planned evaluations or examinations for bowel related complaints

  • Known presence of:

    • Endometriosis or polycystic ovarian syndrome
    • Diabetes type 1 and 2
    • Systemic disease including
  • Morbidly obesity (BMI ≥35)
  • Severe autoimmune disease
  • Severe immune deficiency (acquired, congenital or due to medication)
  • Previous treatment with FMT

  • History of:

    • Severe psychiatric disorder, alcohol or drug abuse. Mood disorders are allowed as long as there is no reason to believe that it will interfere with the ability to participate in the study.
    • Inflammatory bowel disease, microscopic colitis, diverticulitis or ileus
    • Abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy
    • Malignant disease (excluding basalioma)

  • "Red flags'' indicating severe undiagnosed disease including:

    • Night sweats (Repeated episodes of extreme perspiration that may soak nightclothes or bedding)
    • Unintentional weight loss (≥ 4.5 kilograms, or 5% of normal body weight) over less than 12 months without knowing the reason

  • Family history of GI cancer defined as two or more first- or second-degree relatives, with:

    • ≥ 1 diagnosed by age 50, OR
    • ≥ 3 first- or second-degree relatives with GI cancer diagnosis, independent of age

  • Use of the following the previous 4 weeks:

    • Drugs with effects on bowel function..Rescue medication, such as Polyethylene glycol (Laxabon, Movieprep, Movicol) or Loperamide is allowed
    • Drugs with analgesic action. Use of paracetamol, Non.Steroid Anti-Inflammatory Drugs ≤3 days week is allowed.
  • Use of proton pump inhibitors or other antacids ≥3 days week
  • Introduction of antidepressants or anxiolytics the last 12 weeks. Patients on a stable dose >12 weeks are eligible.
  • Treatment with antibiotics 12 weeks prior to study entry.
  • Use of kolestyramin for bile acid malabsorption
  • Pregnant, lactating or planning pregnancy.
  • Physical exam indicating undiagnosed malignant, autoimmune, or infectious disease

  • Laboratory work up indicating undiagnosed digestive, malignant, autoimmune, infectious disease or alternative diagnosis to the IBS related signs and symptoms. The work up includes:

    • Full blood count
    • Erythrocyte sedimentation rate (ESR)
    • C-reactive protein
    • Anti-tissue transglutaminase IgA, total IgA
    • Lactase genotype
    • Stool tests for:
    • Occult blood (Hemofec©).
    • Fecal calprotectin indicating inflammatory bowel disease. The detection limit that excludes participants will depend on which assays is used for analysis at the different study centers.
    • Only if indicated by the patient history (i.e. travelers diarrhea): Stool test for fecal ova and parasite, Clostridoides difficile toxin and pathogenic bacteria (Shigella spp, Salmonella spp. Campylobacter spp, Yersinia spp, and toxin-producing Clostridoides difficile.) All test results must be negative.

Sites / Locations

  • Ålesund Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Fecal microbiota transplant from donor A

Fecal microbiota transplant from donor B

Fecal microbiota transplant from donor C

Fecal microbiota transplant from autologous feces

Arm Description

One FMT delivered by enema

One FMT delivered by enema

One FMT delivered by enema

One FMT delivered by enema

Outcomes

Primary Outcome Measures

Proportion in the donorFMT (dFMT) versus autologousFMT (aFMT) group with ≥75 points decrease in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) day 90 after treatment when compared to the score 8 days before treatment
Scores on the IBS-SSS can range from 0 to 500 with higher scores indicating more severe symptoms. The IBS-SSS has five items. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.

Secondary Outcome Measures

Proportion in dFMT versus aFMT group with ≥75 points decrease in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) day 365 after treatment when compared to the score 8 days before treatment
Proportion of patients in dFMT versus aFMT group with a ≥14 points increase in the IBS-Qualiy of Life (IBS-QoL) day 90 after treatment when compared to the score 8 days before treatment
The IBS-QoL is a validated self-report questionnaire specific to IBS to evaluate quality of life over the past 30 days. It consists of 34 items, each with a five-point Likert scale. The individual response to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. The cut-off for meaningful clinical improvement is set at ≥14 points. There are also eight subscale scores for the IBS-QOL (Dysphoria, Interference with Activity, Body Image, Health Worry, Food Avoidance, Social Reaction, Sexual, Relationships)
Proportion in the dFMT vs aFMT group with 2 or more weeks with treatment success in Adequate relief by the Global Improvement Scale and Abdominal pain day 69, 76, 83 and 90 after treatment. For treatment success criteria A. and B. have to be fulfilled
A. Adequate relief is determined by the patient question "How would you rate your IBS signs and symptoms overall over the past 7 days?". Criteria A. is fulfilled when participants score 1 or 2 on a 7-point numerical rating scale. B. Abdominal pain is determined by the question "How would you rate your abdominal pain overall over the past 7 days?" The patient answer on a 11-point numerical rating scale, where 0 is "No pain" and 10 is "Worst possible pain''. Criteria B. is fulfilled when participants experience a 30% decrease in the scale score after treatment, compared to the score before treatment.
Proportion of adverse events and serious adverse events in the dFMT versus aFMT group from treatment and until day 90 after treatment
Proportion of adverse events and serious adverse events in the dFMT versus aFMT group from treatment and until day 90 after treatment
Change in the dFMT vs aFMT group in mean stool consistency score in the period 8-2 days before treatment, compared to mean stool consistency score in the period 84-90 and 359-365 days after treatment.
This endpoint only apply to participants subtyped with IBS-diarrhea before treatment. Mean stool consistency score is measured by Bristol Stool Scale ("How would you rate the stool consistency overall the last 24 hours?"). Mean stool consistency score will be derived from: (Sum of each rating by the Bristol Stool Form Scale in a period )/(Number of ratings in a period).
Change in the dFMT vs aFMT group in mean number of complete spontaneous bowel movements (CSBM) in the period 8-2 days before treatment, compared to CSBM in the period 84-90 and 359-365 days after treatment
This endpoint only apply to participants subtyped with with IBS-constipation before treatment. CSBM is measured by the question. "How many CSBM have you passed the last 24 hours?" reported by the participant every second day for eight days?'' Mean number of complete spontaneous bowel movements will be derived from: (Sum of number of CSBM in each period)/number of assessments of CSBM in a period)
Change in the dFMT vs aFMT group in bowel-related complaints by the item specific and global Irritable Bowel Syndrome Symptom Severity Score score from before and until after treatment.
Change in the dFMT vs aFMT group in quality of life by the global and subdomain specific score in the Irritable Bowel Syndrome-Qualiy of Life from before and until after treatment.
Change in the dFMT vs aFMT group in fatigue by the global and subdomain specific score in the Modified Fatigue Impact Scale from before and until after treatment.
Items on the MFIS can be aggregated into three subscales (physical (range 0 to 36), cognitive (range 0 to 40), and psychosocial (range 0 to 8)), as well as into a total MFIS score (range 0 to 84). All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities.
Change in the dFMT vs aFMT group in anxiety and depression (HADS) by the global and subdomain specific score on the Hospital Anxiety and Depression Scale from before and until after treatment.
The HADS is a fourteen item scale where seven of the items relate to anxiety and seven to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicates higher levels of anxiety or depression
Proportion of participants identified as treatment success (as defined by the primary endpoint) by a ten species profile generated from a metagenomic dataset from the pilot REFIT trial (unpublished data)
Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in continuous ECG recordings. The primary vagal function outcome will be differences in changes from pre-post treatment between groups in High Frequency HRV (HF-HRV; in ms2).
Firstbeat Bodyguard will record R-R interval and the Firstbeat life style assessment software will analyze the R-R interval recording and provide the outcome measure
Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in continuous ECG recordings. The secondary vagal function outcome will be differences in changes from pre-post treatment between groups in RMSSD (RMSSD; in ms2).
Difference in mean baseline HRV (HF-HRV and RMSSD) between responders' vs non-responders to donor FMT.
As defined by the primary endpoint in the clinical phase III study, a responder will be defined by a decrease of 75 points from baseline in the irritable bowel symptom severity score 90 days after the intervention with FMT. To determine HRV in each group we will use High Frequency Power analysis denominating HRV in ms2.

Full Information

First Posted
December 15, 2020
Last Updated
October 27, 2022
Sponsor
University Hospital of North Norway
Collaborators
Oslo University Hospital, Sorlandet Hospital HF, Haukeland University Hospital, Alesund Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04691544
Brief Title
Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Official Title
Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome: a Double Blind, Placebo-Controlled, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Oslo University Hospital, Sorlandet Hospital HF, Haukeland University Hospital, Alesund Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Many patients with irritable bowel syndrome (IBS) do not experience adequate symptom relief with current treatments. The pathophysiology of IBS is diverse, controversial and not completely understood. The next disruptive frontier would be to find a cure where the effect is predictable and lasting. The study groups phase 2 pilot trial was the first indication of a possible benefit from treating IBS with fecal microbiota transplantation (FMT) (Number needed to treat only five) (Fecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomized, placebo-controlled, parallel-group, single-centre trial he Lancet Gastroenterology and Hepatology 2018). Additional results from the same trial show that the treatment response may be predicted (unpublished data), and that the pathophysiologic mechanisms behind the treatment response also can be identified (Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome, Gut Microbes 2020). This study is the first phase 3 trial of FMT for IBS worldwide. The hypothesis of the trial is that donor FMT is more effective than placebo FMT in treating IBS, with little adverse events or complications. Patients ≥18 years with IBS are enrolled at five Norwegian Hospitals in this double blind randomized, placebo controlled, parallell-group multi center trial. Participants are randomized to FMT from a healthy donor (intervention group), or their own feces (placebo group). The primary outcome is the proportion of patients with ≥75 points decrease in the Irritable bowel Symptom Severity score 90 days after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
fecal microbiota therapy, bacteriotherapy, stool transplant, IBS, FMT, gut microbiota brain axis, functional disorder, IBS-M, IBS-D, IBS-C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Triple blind randomized, placebo controlled, parallell-group multi center trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fecal microbiota transplant from donor A
Arm Type
Active Comparator
Arm Description
One FMT delivered by enema
Arm Title
Fecal microbiota transplant from donor B
Arm Type
Active Comparator
Arm Description
One FMT delivered by enema
Arm Title
Fecal microbiota transplant from donor C
Arm Type
Active Comparator
Arm Description
One FMT delivered by enema
Arm Title
Fecal microbiota transplant from autologous feces
Arm Type
Placebo Comparator
Arm Description
One FMT delivered by enema
Intervention Type
Biological
Intervention Name(s)
Fecal microbiota transplantation (FMT)
Intervention Description
Delivered by enema
Primary Outcome Measure Information:
Title
Proportion in the donorFMT (dFMT) versus autologousFMT (aFMT) group with ≥75 points decrease in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) day 90 after treatment when compared to the score 8 days before treatment
Description
Scores on the IBS-SSS can range from 0 to 500 with higher scores indicating more severe symptoms. The IBS-SSS has five items. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.
Time Frame
Day 90 after treatment
Secondary Outcome Measure Information:
Title
Proportion in dFMT versus aFMT group with ≥75 points decrease in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) day 365 after treatment when compared to the score 8 days before treatment
Time Frame
Day 365 after treatment
Title
Proportion of patients in dFMT versus aFMT group with a ≥14 points increase in the IBS-Qualiy of Life (IBS-QoL) day 90 after treatment when compared to the score 8 days before treatment
Description
The IBS-QoL is a validated self-report questionnaire specific to IBS to evaluate quality of life over the past 30 days. It consists of 34 items, each with a five-point Likert scale. The individual response to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. The cut-off for meaningful clinical improvement is set at ≥14 points. There are also eight subscale scores for the IBS-QOL (Dysphoria, Interference with Activity, Body Image, Health Worry, Food Avoidance, Social Reaction, Sexual, Relationships)
Time Frame
Day 90 after treatment
Title
Proportion in the dFMT vs aFMT group with 2 or more weeks with treatment success in Adequate relief by the Global Improvement Scale and Abdominal pain day 69, 76, 83 and 90 after treatment. For treatment success criteria A. and B. have to be fulfilled
Description
A. Adequate relief is determined by the patient question "How would you rate your IBS signs and symptoms overall over the past 7 days?". Criteria A. is fulfilled when participants score 1 or 2 on a 7-point numerical rating scale. B. Abdominal pain is determined by the question "How would you rate your abdominal pain overall over the past 7 days?" The patient answer on a 11-point numerical rating scale, where 0 is "No pain" and 10 is "Worst possible pain''. Criteria B. is fulfilled when participants experience a 30% decrease in the scale score after treatment, compared to the score before treatment.
Time Frame
Day 69, 76, 83 and 90 after treatment
Title
Proportion of adverse events and serious adverse events in the dFMT versus aFMT group from treatment and until day 90 after treatment
Time Frame
Day 90 after treatment
Title
Proportion of adverse events and serious adverse events in the dFMT versus aFMT group from treatment and until day 90 after treatment
Time Frame
Day 365 after treatment
Title
Change in the dFMT vs aFMT group in mean stool consistency score in the period 8-2 days before treatment, compared to mean stool consistency score in the period 84-90 and 359-365 days after treatment.
Description
This endpoint only apply to participants subtyped with IBS-diarrhea before treatment. Mean stool consistency score is measured by Bristol Stool Scale ("How would you rate the stool consistency overall the last 24 hours?"). Mean stool consistency score will be derived from: (Sum of each rating by the Bristol Stool Form Scale in a period )/(Number of ratings in a period).
Time Frame
2-8 days before treatment and day 84 to 90 and day 259 to 365 after treatment
Title
Change in the dFMT vs aFMT group in mean number of complete spontaneous bowel movements (CSBM) in the period 8-2 days before treatment, compared to CSBM in the period 84-90 and 359-365 days after treatment
Description
This endpoint only apply to participants subtyped with with IBS-constipation before treatment. CSBM is measured by the question. "How many CSBM have you passed the last 24 hours?" reported by the participant every second day for eight days?'' Mean number of complete spontaneous bowel movements will be derived from: (Sum of number of CSBM in each period)/number of assessments of CSBM in a period)
Time Frame
2-8 days before treatment and day 84 to 90 and day 259 to 365 after treatment
Title
Change in the dFMT vs aFMT group in bowel-related complaints by the item specific and global Irritable Bowel Syndrome Symptom Severity Score score from before and until after treatment.
Time Frame
8 days before treatment and until 30, 90, 180 and 365 days after treatment
Title
Change in the dFMT vs aFMT group in quality of life by the global and subdomain specific score in the Irritable Bowel Syndrome-Qualiy of Life from before and until after treatment.
Time Frame
8 days before treatment and until 90, 180 and 365 days after treatment
Title
Change in the dFMT vs aFMT group in fatigue by the global and subdomain specific score in the Modified Fatigue Impact Scale from before and until after treatment.
Description
Items on the MFIS can be aggregated into three subscales (physical (range 0 to 36), cognitive (range 0 to 40), and psychosocial (range 0 to 8)), as well as into a total MFIS score (range 0 to 84). All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities.
Time Frame
8 days before treatment and until 90, 180 and 365 days after treatment
Title
Change in the dFMT vs aFMT group in anxiety and depression (HADS) by the global and subdomain specific score on the Hospital Anxiety and Depression Scale from before and until after treatment.
Description
The HADS is a fourteen item scale where seven of the items relate to anxiety and seven to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicates higher levels of anxiety or depression
Time Frame
8 days before treatment and until 90, 180 and 365 days after treatment
Title
Proportion of participants identified as treatment success (as defined by the primary endpoint) by a ten species profile generated from a metagenomic dataset from the pilot REFIT trial (unpublished data)
Time Frame
Day 90
Title
Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in continuous ECG recordings. The primary vagal function outcome will be differences in changes from pre-post treatment between groups in High Frequency HRV (HF-HRV; in ms2).
Description
Firstbeat Bodyguard will record R-R interval and the Firstbeat life style assessment software will analyze the R-R interval recording and provide the outcome measure
Time Frame
90 days after treatment
Title
Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in continuous ECG recordings. The secondary vagal function outcome will be differences in changes from pre-post treatment between groups in RMSSD (RMSSD; in ms2).
Time Frame
90 days after treatment
Title
Difference in mean baseline HRV (HF-HRV and RMSSD) between responders' vs non-responders to donor FMT.
Description
As defined by the primary endpoint in the clinical phase III study, a responder will be defined by a decrease of 75 points from baseline in the irritable bowel symptom severity score 90 days after the intervention with FMT. To determine HRV in each group we will use High Frequency Power analysis denominating HRV in ms2.
Time Frame
90 days after treatment
Other Pre-specified Outcome Measures:
Title
Changes in taxonomy and function of the microbiome, the immune system, metabolome and gut epithelial barrier in participants with vs without treatment success to dFMT and aFMT from before and until after treatment.
Description
This exploratory endpoint will be further specified when all participants has completed their 12 months follow up after treatment. To explore the changes described above stool, serum, plasma and urine is obtained from participants before and at 90 and 365 days after treatment. The biobanking at 365 will only be performed on a subset of participants. Stool from each donor feces donation will also be biobanked.
Time Frame
8 days before treatment and until 90 and 365 days after treatment
Title
Differences in taxonomy and function of the microbiome, the immune system, metabolome and gut epithelial barrier before treatment in FMT donors vs participants with vs without treatment success to dFMT and aFMT from before and until after treatment.
Description
This exploratory endpoint will be further specified when all participants has completed their 12 months follow up after treatment. To explore the changes described above stool, serum, plasma and urine is obtained from participants before and at 90 and 365 days after treatment. The biobanking at 365 will only be performed on a subset of participants. Stool from each donor feces donation will also be biobanked.
Time Frame
8 days before treatment and until 90 and 365 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Diagnosed with IBS in the primary or secondary health care service Aged 18-65 years with IBS defined by the Rome IV criteria: Moderate to severe IBS symptoms, as defined by a score of ≥175 on the IBS-SSS All participants >50 years: Colonoscopy within the last 5 years prior to study entry including negative mucosal biopsy for microscopic colitis in participants subtyped as IBS-D Exclusion Planned evaluations or examinations for bowel related complaints Known presence of: Endometriosis or polycystic ovarian syndrome Diabetes type 1 and 2 Systemic disease including Morbidly obesity (BMI ≥35) Severe autoimmune disease Severe immune deficiency (acquired, congenital or due to medication) Previous treatment with FMT History of: Severe psychiatric disorder, alcohol or drug abuse. Mood disorders are allowed as long as there is no reason to believe that it will interfere with the ability to participate in the study. Inflammatory bowel disease, microscopic colitis, diverticulitis or ileus Abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy Malignant disease (excluding basalioma) "Red flags'' indicating severe undiagnosed disease including: Night sweats (Repeated episodes of extreme perspiration that may soak nightclothes or bedding) Unintentional weight loss (≥ 4.5 kilograms, or 5% of normal body weight) over less than 12 months without knowing the reason Family history of GI cancer defined as two or more first- or second-degree relatives, with: ≥ 1 diagnosed by age 50, OR ≥ 3 first- or second-degree relatives with GI cancer diagnosis, independent of age Use of the following the previous 4 weeks: Drugs with effects on bowel function..Rescue medication, such as Polyethylene glycol (Laxabon, Movieprep, Movicol) or Loperamide is allowed Drugs with analgesic action. Use of paracetamol, Non.Steroid Anti-Inflammatory Drugs ≤3 days week is allowed. Use of proton pump inhibitors or other antacids ≥3 days week Introduction of antidepressants or anxiolytics the last 12 weeks. Patients on a stable dose >12 weeks are eligible. Treatment with antibiotics 12 weeks prior to study entry. Use of kolestyramin for bile acid malabsorption Pregnant, lactating or planning pregnancy. Physical exam indicating undiagnosed malignant, autoimmune, or infectious disease Laboratory work up indicating undiagnosed digestive, malignant, autoimmune, infectious disease or alternative diagnosis to the IBS related signs and symptoms. The work up includes: Full blood count Erythrocyte sedimentation rate (ESR) C-reactive protein Anti-tissue transglutaminase IgA, total IgA Lactase genotype Stool tests for: Occult blood (Hemofec©). Fecal calprotectin indicating inflammatory bowel disease. The detection limit that excludes participants will depend on which assays is used for analysis at the different study centers. Only if indicated by the patient history (i.e. travelers diarrhea): Stool test for fecal ova and parasite, Clostridoides difficile toxin and pathogenic bacteria (Shigella spp, Salmonella spp. Campylobacter spp, Yersinia spp, and toxin-producing Clostridoides difficile.) All test results must be negative.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H Johnsen, MD PhD
Organizational Affiliation
Univeristy Hospital of North Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rasmus Goll, MD PhD
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ålesund Hospital
City
Ålesund
Country
Norway

12. IPD Sharing Statement

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Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome

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