Irritable Bowel SyndromeNCT03822299
Effects of Faecal Microbiota Transplantation in Patients With IBS
A study testing healthy feces microbiota in people with Irritable Bowel Syndrome, run by Helse Fonna at 1 site in Norway.
Trial summary
Irritable bowel syndrom (IBS) is a common chronic gastrointestinal disorder that affects 10-20% of the world population. The prevalence of IBS in Norway is between 8% and 25%. The pathophysiology of IBS is incompletely understood, and there is no effective treatment for this condition. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- healthy feces microbiota
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to 5 May 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between who fulfill Rome IV criteria for the diagnosis of IBS.
- Patients with moderate to severe IBS symptoms (IBS-SSS ≥ 175).
Who cannot join
- Pregnant, planning pregnancy or lactating women.
- The use of antibiotics or probiotics within 1 month prior to FMT.
- Patients who had undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, Caesarean section or hysterectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Faecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome: A Randomised, Double-blind Placebo-controlled Study
Irritable bowel syndrom (IBS) is a common chronic gastrointestinal disorder that affects 10-20% of the world population. The prevalence of IBS in Norway is between 8% and 25%. The pathophysiology of IBS is incompletely understood, and there is no effective treatment for this condition. Imbalance (dysbiosis) of the gut microbiome has been found in patients with IBS. In the absence of effective method to restore the dysbiosis, transplantation of a microbiome from healthy individuals with well-functioning gut (FMT) to those with IBS has been performed. Two randomized double blind placebo-controlled (RCT) studies have been published recently. Whereas it was reported in one study that FMT reduced symptom and improved quality of life in patients with IBS, FMT had no effect in the other study. In order to clarify these contradictory results, a new RCT study that enrolled larger number of patients is required. In this study, the investigators intend to recruit 170 IBS patients from those attending outdoor clinic at Stord hospital in a randomized, double blind placebo trial. A single healthy donor with well-characterized microbiome is going to be used. The effects on symptoms, quality of life, fatigue as well as dysbiosis before and after FMT are going to be investigated. The possible mechanisms behind the effects if any of FMT such as changes in intestinal stem cells, enteroendocrine cells and local immune defense shall be also investigated. The patients are going to be randomized either to placebo (own faces), 30 g or 60 g of the donor faces in ratio 1:1:1.
Read the detailed description
Study design Patients One hundred and seventy patients who fulfill the following inclusion criteria and lack the exclusion criteria shall be included. In addition, the patients are examined physically, and blood tests are taken to exclude inflammation, and liver, kidney and thyroid diseases. They undergo further gastroscopy with duodenal biopsies to exclude coeliac disease. They undergo also colonoscopy to exclude malignity, or inflammatory bowel disease (IBD). Microscopic colitis is excluded by examining tissue obtained by colonoscopy with segmental biopsy sampling.
Donor selection and screening:
A single donor shall be selected and screened according to the European and international guidelines. The donor should not be a first-degree relative to any of the patients, as the intestinal microbiota is affected by the genetic composition, and similarity between the donor and recipient in the fecal microbiota may occur.
Protocol
Feces collection, preparation and administration:
Feces from both the donors and recipients were collected and stored at - 80•. Frozen feces (30 or 60g) from the donor or patients (placebo), thawed at 5° C and were dissolved in 50 mL of 0.9% sterile saline per 30 g feces. The dissolved stool is administrated to the patients, after overnight fast, through working channel of gastroduodeno-scope in pars descendent duodenum distal to the papilla of Vater.
Sigmoidoscopy: After administration of faeces, a sigmoidoscopy is performed during which 4 biopsies from the sigmoid colon about 30 cm from anus, and 4 biopsies from the rectum about 15 cm from anus are taken. Sigmoidoscopy is repeated in the same way 1 month after FMT.
Methods Questionnaires
- IBS symptom severity Scale (IBS-SSS) questionnaire.
- Birmingham Symptom scale questionnaires.
- IBSQoL questionnaire.
- Short form of Nepean Dyspepsia Index (SF-NDI) questionnaire.
- Fatigue Assessment Scale (FAS).
Microbiome analysis Gut microbiota analysis was performed using the GA-mapTM Dysbiosis test (Genetic Analysis AS, Oslo, Norway) by algorithmically assessing fecal bacterial abundance and profile (dysbiosis index, DI), and potential deviation in the microbiome from normobiosis. GA-map test is based on fecal 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 labeling is by single nucleotide extension and hybridization to complementary probes coupled to magnetic beads, and signal detection by using Bio Code 1000A 128-Plex Analyzer (Applied Bio Code, 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
- healthy feces microbiota
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthy feces microbiotaDietary supplement
Also called placebo
Suspension of healthy feces microbiota in sterile saline solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Patients receive suspension of their own feces. |
| 30 g donor dose | Active comparator | Patients receiving 30 g of a healthy donor feces. Receives: Dietary Supplement: healthy feces microbiota |
| 60 g donor dose | Active comparator | Patients receiving 60 g of a healthy donor feces. Receives: Dietary Supplement: healthy feces microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global improvement in IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS)
IBS-SSS is a visual assessment scale (VAS) rating from 0 to 100, with total scores ranging from 0 to 500. Lower scores indicate improvement.
Measured: 3 months.
Global improvement in IBS symptoms as assessed by Birmingham Symptom scale questionnaire
This questionnaire consists of 11 question. measured on a six-point Likert scale ranging from 0 to 5. Lower scores indicate improvement.
Measured: 3 months.
Quality of life as assessed by IBS quality of life (IBSQoL) questionnaire
IBSQoL consist of 34- questions measured on a five-point Likert scale ranging from 0 to 5. Higher scores indicate improvement.
Measured: 3 months
Quality of life as assessed by Short form of Nepean Dyspepsia Index (SF-NDI) questionnaires
SF-NDI is a five-point Likert scale ranging from 0 to 5. Lower scores indicate improvement.
Measured: 3 months
Fatigue as assessed by: Fatigue Assessment Scale (FAS) questionnaire
FAS is a five-point Likert scale ranging from 0 to 5. Lower scores indicate improvement.
Measured: 3 months
Secondary outcomes (1)
Stool microbiota changes as assessed by the Dysbiosis index (DI)
DI is a 5-point scale: DI 1-2: non-dysbiosis, DI: moderate, DI 4-5: severe dysbiosis). Higer scores indicate improvement.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Jan 2018
- Primary completion30 Apr 2019
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Model description
- Intervention. Dietary supplement: fecal suspension. Healthy donor or own faeces (placebo) administrated through working canal of a gastroscope.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Vest
- Responsible party
- Principal investigator, Magdy El-Salhy, MD, PhD, Helse Fonna
- Investigators
- Haldis Lier, MD, PhD, Study director, Head of Research Department at Helse Finna HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822299
- Sponsor's protocol ID
- HelseFonna
- Status last verified
- May 2019
- First submitted
- 21 Dec 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data are stored at Helse Vest server. Anonymous patients data is available to other research on demand.
Publications
El-Salhy M, Valeur J, Bronstad I, Gilja OH, Hatlebakk JG. Possible Role of Butyric Acid in Long-Term Symptom Relief in Irritable Bowel Syndrome Patients Following Fecal Microbiota Transplantation. Neurogastroenterol Motil. 2025 Dec;37(12):e70115. doi: 10.1111/nmo.70115. Epub 2025 Aug 1.
PubMed 40751371El-Salhy M, Winkel R, Casen C, Hausken T, Gilja OH, Hatlebakk JG. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14.
PubMed 35709830El-Salhy M, Mazzawi T, Hausken T, Hatlebakk JG. The fecal microbiota transplantation response differs between patients with severe and moderate irritable bowel symptoms. Scand J Gastroenterol. 2022 Sep;57(9):1036-1045. doi: 10.1080/00365521.2022.2064725. Epub 2022 Apr 29.
PubMed 35486073El-Salhy M, Mazzawi T, Hausken T, Hatlebakk JG. Irritable bowel syndrome patients who are not likely to respond to fecal microbiota transplantation. Neurogastroenterol Motil. 2022 Sep;34(9):e14353. doi: 10.1111/nmo.14353. Epub 2022 Mar 18.
PubMed 35302268El-Salhy M, Kristoffersen AB, Valeur J, Casen C, Hatlebakk JG, Gilja OH, Hausken T. Long-term effects of fecal microbiota transplantation (FMT) in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2022 Jan;34(1):e14200. doi: 10.1111/nmo.14200. Epub 2021 Jun 18.
PubMed 34145677El-Salhy M, Valeur J, Hausken T, Gunnar Hatlebakk J. Changes in fecal short-chain fatty acids following fecal microbiota transplantation in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2021 Feb;33(2):e13983. doi: 10.1111/nmo.13983. Epub 2020 Sep 17.
PubMed 32945066El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.
PubMed 31852769
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Faecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome: A Randomised, Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03822299
- Acronym / sponsor ID
- HelseFonna
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Collaborators
- Helse Vest
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 30 Jan 2019 (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.
Irritable bowel syndrom (IBS) is a common chronic gastrointestinal disorder that affects 10-20% of the world population. The prevalence of IBS in Norway is between 8% and 25%. The pathophysiology of IBS is incompletely understood, and there is no effective treatment for this condition. Imbalance (dysbiosis) of the gut microbiome has been found in patients with IBS. In the absence of effective method to restore the dysbiosis, transplantation of a microbiome from healthy individuals with well-functioning gut (FMT) to those with IBS has been performed. Two randomized double blind placebo-controlled (RCT) studies have been published recently. Whereas it was reported in one study that FMT reduced symptom and improved quality of life in patients with IBS, FMT had no effect in the other study. In order to clarify these contradictory results, a new RCT study that enrolled larger number of patients is required. In this study, the investigators intend to recruit 170 IBS patients from those attending outdoor clinic at Stord hospital in a randomized, double blind placebo trial. A single healthy donor with well-characterized microbiome is going to be used. The effects on symptoms, quality of life, fatigue as well as dysbiosis before and after FMT are going to be investigated. The possible mechanisms behind the effects if any of FMT such as changes in intestinal stem cells, enteroendocrine cells and local immune defense shall be also investigated. The patients are going to be randomized either to placebo (own faces), 30 g or 60 g of the donor faces in ratio 1:1:1.
Detailed description
Study design Patients One hundred and seventy patients who fulfill the following inclusion criteria and lack the exclusion criteria shall be included. In addition, the patients are examined physically, and blood tests are taken to exclude inflammation, and liver, kidney and thyroid diseases. They undergo further gastroscopy with duodenal biopsies to exclude coeliac disease. They undergo also colonoscopy to exclude malignity, or inflammatory bowel disease (IBD). Microscopic colitis is excluded by examining tissue obtained by colonoscopy with segmental biopsy sampling.
Donor selection and screening:
A single donor shall be selected and screened according to the European and international guidelines. The donor should not be a first-degree relative to any of the patients, as the intestinal microbiota is affected by the genetic composition, and similarity between the donor and recipient in the fecal microbiota may occur.
Protocol
Feces collection, preparation and administration:
Feces from both the donors and recipients were collected and stored at - 80•. Frozen feces (30 or 60g) from the donor or patients (placebo), thawed at 5° C and were dissolved in 50 mL of 0.9% sterile saline per 30 g feces. The dissolved stool is administrated to the patients, after overnight fast, through working channel of gastroduodeno-scope in pars descendent duodenum distal to the papilla of Vater.
Sigmoidoscopy: After administration of faeces, a sigmoidoscopy is performed during which 4 biopsies from the sigmoid colon about 30 cm from anus, and 4 biopsies from the rectum about 15 cm from anus are taken. Sigmoidoscopy is repeated in the same way 1 month after FMT.
Methods Questionnaires
- IBS symptom severity Scale (IBS-SSS) questionnaire.
- Birmingham Symptom scale questionnaires.
- IBSQoL questionnaire.
- Short form of Nepean Dyspepsia Index (SF-NDI) questionnaire.
- Fatigue Assessment Scale (FAS).
Microbiome analysis Gut microbiota analysis was performed using the GA-mapTM Dysbiosis test (Genetic Analysis AS, Oslo, Norway) by algorithmically assessing fecal bacterial abundance and profile (dysbiosis index, DI), and potential deviation in the microbiome from normobiosis. GA-map test is based on fecal 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 labeling is by single nucleotide extension and hybridization to complementary probes coupled to magnetic beads, and signal detection by using Bio Code 1000A 128-Plex Analyzer (Applied Bio Code, 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
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Intervention. Dietary supplement: fecal suspension. Healthy donor or own faeces (placebo) administrated through working canal of a gastroscope.
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –Patients receive suspension of their own feces. |
| 30 g donor dose | Active comparator | Dietary Supplement: healthy feces microbiotaPatients receiving 30 g of a healthy donor feces. |
| 60 g donor dose | Active comparator | Dietary Supplement: healthy feces microbiotaPatients receiving 60 g of a healthy donor feces. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between who fulfill Rome IV criteria for the diagnosis of IBS.
- Patients with moderate to severe IBS symptoms (IBS-SSS ≥ 175).
Key exclusion criteria (3 listed)
- Pregnant, planning pregnancy or lactating women.
- The use of antibiotics or probiotics within 1 month prior to FMT.
- Patients who had undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, Caesarean section or hysterectomy.
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 |
|---|---|---|
| healthy feces microbiotaAlso: placeboSuspension of healthy feces microbiota in sterile saline solution | Dietary supplement | 30 g donor dose, 60 g donor dose |
Primary outcome
Global improvement in IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS)
Time frame: 3 months.
IBS-SSS is a visual assessment scale (VAS) rating from 0 to 100, with total scores ranging from 0 to 500. Lower scores indicate improvement.
Global improvement in IBS symptoms as assessed by Birmingham Symptom scale questionnaire
Time frame: 3 months.
This questionnaire consists of 11 question. measured on a six-point Likert scale ranging from 0 to 5. Lower scores indicate improvement.
Quality of life as assessed by IBS quality of life (IBSQoL) questionnaire
Time frame: 3 months
IBSQoL consist of 34- questions measured on a five-point Likert scale ranging from 0 to 5. Higher scores indicate improvement.
Quality of life as assessed by Short form of Nepean Dyspepsia Index (SF-NDI) questionnaires
Time frame: 3 months
SF-NDI is a five-point Likert scale ranging from 0 to 5. Lower scores indicate improvement.
Fatigue as assessed by: Fatigue Assessment Scale (FAS) questionnaire
Time frame: 3 months
FAS is a five-point Likert scale ranging from 0 to 5. Lower scores indicate improvement.
1 secondary outcome
Stool microbiota changes as assessed by the Dysbiosis index (DI)
Time frame: 3 months.
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 7 May 2019.
- Derived from this study: PubMed 40751371El-Salhy M, Valeur J, Bronstad I, Gilja OH, Hatlebakk JG. Possible Role of Butyric Acid in Long-Term Symptom Relief in Irritable Bowel Syndrome Patients Following Fecal Microbiota Transplantation. Neurogastroenterol Motil. 2025 Dec;37(12):e70115. doi: 10.1111/nmo.70115. Epub 2025 Aug 1.
- Derived from this study: PubMed 35709830El-Salhy M, Winkel R, Casen C, Hausken T, Gilja OH, Hatlebakk JG. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14.
- Derived from this study: PubMed 35486073El-Salhy M, Mazzawi T, Hausken T, Hatlebakk JG. The fecal microbiota transplantation response differs between patients with severe and moderate irritable bowel symptoms. Scand J Gastroenterol. 2022 Sep;57(9):1036-1045. doi: 10.1080/00365521.2022.2064725. Epub 2022 Apr 29.
- Derived from this study: PubMed 35302268El-Salhy M, Mazzawi T, Hausken T, Hatlebakk JG. Irritable bowel syndrome patients who are not likely to respond to fecal microbiota transplantation. Neurogastroenterol Motil. 2022 Sep;34(9):e14353. doi: 10.1111/nmo.14353. Epub 2022 Mar 18.
- Derived from this study: PubMed 34145677El-Salhy M, Kristoffersen AB, Valeur J, Casen C, Hatlebakk JG, Gilja OH, Hausken T. Long-term effects of fecal microbiota transplantation (FMT) in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2022 Jan;34(1):e14200. doi: 10.1111/nmo.14200. Epub 2021 Jun 18.
- Derived from this study: PubMed 32945066El-Salhy M, Valeur J, Hausken T, Gunnar Hatlebakk J. Changes in fecal short-chain fatty acids following fecal microbiota transplantation in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2021 Feb;33(2):e13983. doi: 10.1111/nmo.13983. Epub 2020 Sep 17.
- Derived from this study: PubMed 31852769El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.
- Individual participant dataSharing planned: No. All data are stored at Helse Vest server. Anonymous patients data is available to other research on demand.
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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.
Haldis Lier, MD, PhD study director
Head of Research Department at Helse Finna HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing healthy feces microbiota 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 2 inclusion and 3 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 7 May 2019. 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?
Global improvement in IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS) (time frame: 3 months.). The study lists 5 primary outcomes in all. 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 NCT03822299, which also lists 7 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 7 May 2019.