Irritable Bowel SyndromeNCT04236843
Faecal Microbiota Transplantation (FMT) in Patients With IBSmechanism(s) of Action
A study testing Feces in people with Irritable Bowel Syndrome, run by Helse Fonna at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Feces
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteNorway
- Study dates
- 3 Feb 2020to 25 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Faecal Microbiota Transplantation (FMT) in Patients With Irritable Bowel Syndrome (IBS): Optimizing the Treatment and Its Mechanism(s) of Action
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.
Read the detailed description
Patients Two hundrad patients who fulfil Rome IV criteria for irritable bowel syndrome (IBS) shall be included in the study. All the IBS subtypes shall be included.
Donor Investigators are going to use the same super-donor they used in their previous randomised double-blind, placebo-controlled study. The donor is athletic Caucasian man aging 36 years. He is non-smoker and is completely healthy without any medication and with a BMI of 23.5. He is not relative to any of the patients in the trial. He was borne by vaginal delivery and breastfeed. He was treated 3 times with antibiotics during his life. He trains 5 times weekly an hour each time. He took regularly dietary supplements rich in proteins, vitamins, fibres and minerals that made his diet richer than average in these substances. He was screened according to the guidelines for donors for FMT. Before he was accepted as a donor the microbiota was analysed in a faecal sample using GA-map Dysbiosis test. The analysis revealed a dysbiosis index (DI)= 1, indicating normobiosysis. In addition, he had excess of bacteria belonging to the Firmicutes. His faeces shall be tested every third moth during the trial.
Protocol
The patients are randomized to either 90 g transplant, 90 g transplant twice with 1week interval into the distal small intestine, or to 90 g transplant into the coecum of the colon. The patients shall complete 5 questionnaires and deliver fecal samples at the baseline, and at 3 , 6 , and 12 months after FMT.
Faeces collection, preparation and administration Faeces from both the donor and patients shall be collected and stored at - 80•. Frozen faeces shall be thawed and each 30 g is dissolved in 30 mL of 0.9% sterile saline. The dissolved stool administrated to the patients, after overnight fast, through working channel of gastroduodeno-scope in pars descendent duodenum distal to the papilla of Vater or to the coecum through working channel of a colonoscope.
Analysis Questionnaires
- IBS symptom severity Scale (IBS-SSS).
- Birmingham Symptom scale.
- IBS-quality of life (IBSQo) Questionnaire.
- Short form of Nepean Dyspepsia Index (SF-NDI).
- Fatigue Assessment Scale (FAS).
Microbiome analysis Gut microbiota analysis is performed using the Genetic analysis-mapTM Dysbiosis test (Genetic Analysis AS, Oslo, Norway) by algorithmically assessing faecal bacterial abundance and profile (dysbiosis index, DI), and potential deviation in the microbiome from normobiosis. GA-map test is based on faecal homogenization, mechanical bacterial cell disruption and automated total bacterial genomic DNA extraction using magnetic beads. DI is based on 54 DNA probes targeting more than 300 bacterial strains based on their 16S rRNA sequence in seven variable regions (V3-V9). Twenty-six bacteria probes are species specific, 19 detect bacteria on genus level, and 9 probes detect bacteria at higher taxonomic levels. Probe labelling is by single nucleotide extension and hybridization to complementary probes coupled to magnetic beads, and signal detection by using BioCode 1000A 128-Plex Analyser (Applied BioCode, Santa Fe Springs, CA, USA). A DI above 2 shows a microbiota profile that differs from that of the normobiotic reference collection (DI 1-2: non-dysbiosis, DI: moderate, DI 4-5: severe dysbiosis).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Feces
- Keywords
- Fecal microbiota transplantation, Intestinal microbiota, Donor, Dysbiosis, Abdominal symptom, Fatigue, Quality of life
- Medical subject headings
- Irritable Bowel Syndrome, Dysbiosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FecesDietary supplement
Feces from healthy donor
| Study group | Role | What they receive |
|---|---|---|
| Smal intestine once | Active comparator | 90-g fecal transplant given into the small intestine once. Receives: Dietary Supplement: Feces |
| Small intestine twice | Active comparator | 90-g fecal transplant given into the small intestine twice with 1 week interval. Receives: Dietary Supplement: Feces |
| Large intestine once | Active comparator | 90-g fecal transplant given into the large intestine once. Receives: Dietary Supplement: Feces |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after FMT
Secondary outcomes (1)
Change in the Dysbiosis index
Dysbiosis index (DI) is a 5 -scale index. A DI above 2 shows a microbiota profile that differs from that of the normobiotic reference collection (DI 1-2: non-dysbiosis, DI 3: moderate, DI 4-5: severe dysbiosis)
Measured: 12 months after FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start3 Feb 2020
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Magdy El-Salhy, MD,PhD, Study chair, Helse Fonna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236843
- Sponsor's protocol ID
- Helse Fonna
- Status last verified
- Aug 2023
- First submitted
- 15 Jan 2020
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38843950El-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.
PubMed 38446309El-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.
PubMed 38084725El-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.
PubMed 37427566
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation (FMT) in Patients With Irritable Bowel Syndrome (IBS): Optimizing the Treatment and Its Mechanism(s) of Action
- ClinicalTrials.gov ID
- NCT04236843
- Acronym / sponsor ID
- Helse Fonna
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Fecal microbiota transplantation, Intestinal microbiota, Donor, Dysbiosis, Abdominal symptom, Fatigue, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients Two hundrad patients who fulfil Rome IV criteria for irritable bowel syndrome (IBS) shall be included in the study. All the IBS subtypes shall be included.
Donor Investigators are going to use the same super-donor they used in their previous randomised double-blind, placebo-controlled study. The donor is athletic Caucasian man aging 36 years. He is non-smoker and is completely healthy without any medication and with a BMI of 23.5. He is not relative to any of the patients in the trial. He was borne by vaginal delivery and breastfeed. He was treated 3 times with antibiotics during his life. He trains 5 times weekly an hour each time. He took regularly dietary supplements rich in proteins, vitamins, fibres and minerals that made his diet richer than average in these substances. He was screened according to the guidelines for donors for FMT. Before he was accepted as a donor the microbiota was analysed in a faecal sample using GA-map Dysbiosis test. The analysis revealed a dysbiosis index (DI)= 1, indicating normobiosysis. In addition, he had excess of bacteria belonging to the Firmicutes. His faeces shall be tested every third moth during the trial.
Protocol
The patients are randomized to either 90 g transplant, 90 g transplant twice with 1week interval into the distal small intestine, or to 90 g transplant into the coecum of the colon. The patients shall complete 5 questionnaires and deliver fecal samples at the baseline, and at 3 , 6 , and 12 months after FMT.
Faeces collection, preparation and administration Faeces from both the donor and patients shall be collected and stored at - 80•. Frozen faeces shall be thawed and each 30 g is dissolved in 30 mL of 0.9% sterile saline. The dissolved stool administrated to the patients, after overnight fast, through working channel of gastroduodeno-scope in pars descendent duodenum distal to the papilla of Vater or to the coecum through working channel of a colonoscope.
Analysis Questionnaires
- IBS symptom severity Scale (IBS-SSS).
- Birmingham Symptom scale.
- IBS-quality of life (IBSQo) Questionnaire.
- Short form of Nepean Dyspepsia Index (SF-NDI).
- Fatigue Assessment Scale (FAS).
Microbiome analysis Gut microbiota analysis is performed using the Genetic analysis-mapTM Dysbiosis test (Genetic Analysis AS, Oslo, Norway) by algorithmically assessing faecal bacterial abundance and profile (dysbiosis index, DI), and potential deviation in the microbiome from normobiosis. GA-map test is based on faecal homogenization, mechanical bacterial cell disruption and automated total bacterial genomic DNA extraction using magnetic beads. DI is based on 54 DNA probes targeting more than 300 bacterial strains based on their 16S rRNA sequence in seven variable regions (V3-V9). Twenty-six bacteria probes are species specific, 19 detect bacteria on genus level, and 9 probes detect bacteria at higher taxonomic levels. Probe labelling is by single nucleotide extension and hybridization to complementary probes coupled to magnetic beads, and signal detection by using BioCode 1000A 128-Plex Analyser (Applied BioCode, Santa Fe Springs, CA, USA). A DI above 2 shows a microbiota profile that differs from that of the normobiotic reference collection (DI 1-2: non-dysbiosis, DI: moderate, DI 4-5: severe dysbiosis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smal intestine once | Active comparator | Dietary Supplement: Feces90-g fecal transplant given into the small intestine once. |
| Small intestine twice | Active comparator | Dietary Supplement: Feces90-g fecal transplant given into the small intestine twice with 1 week interval. |
| Large intestine once | Active comparator | Dietary Supplement: Feces90-g fecal transplant given into the large intestine once. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FecesFeces from healthy donor | Dietary supplement | Large intestine once, Smal intestine once, Small intestine twice |
Primary outcome
Change in IBS-SSS total score
Time frame: 12 months after FMT
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.
1 secondary outcome
Change in the Dysbiosis index
Time frame: 12 months after FMT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 38843950El-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.
- Derived from this study: PubMed 38446309El-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.
- Derived from this study: PubMed 38084725El-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.
- Derived from this study: PubMed 37427566El-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.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdy El-Salhy, MD,PhD study chair
Helse Fonna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feces in people with Irritable Bowel Syndrome, run by Helse Fonna at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IBS-SSS total score (time frame: 12 months after FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236843, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.