Irritable Bowel SyndromeGUT-HEAL-IBSNCT06281600
An Intervention Study Using HMOs to Improve IBS Symptoms
A study testing Human milk oligosaccharide in people with Irritable Bowel Syndrome, run by Glenn Gibson at 1 site in United Kingdom.
Trial summary
There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS). Importantly, this enteric population is susceptible to dietary intervention and represents an exciting target for the prevention and treatment of gut mediated disorders. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Human milk oligosaccharide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2024to 20 Sep 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed consent form.
- Adults (aged from 18 to 60).
- Diagnosis of irritable bowel syndrome by a clinician (according to the Rome IV criteria).
- Absence of gut conditions other than IBS.
Who cannot join
- Intake of an experimental drug within four weeks prior to study.
- Former participation in prebiotic, probiotic or laxative trials within the previous four weeks.
- Former participation in a dietary intervention within the previous four weeks.
- Use of antibiotics within the previous four weeks.
- Intake of other specific prebiotics (such as oligosaccharides e.g. inulin), or probiotics (e.g. live yoghurts, other fermented products), drugs active on gastrointestinal motility, or a laxative of any class, for four weeks prior to study.
- Women who are lactating, pregnant or planning pregnancy during the study period.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The University of Reading
Reading, Berkshire, RG6 6LA
Patricia Sanz Morales, +447843865554, p.sanzmorales@pgr.reading.ac.uk
Glenn Gibson, Prof.
About this study
Official title: A Double-blind, Crossover Intervention Study Using Human Milk Oligosaccharides (HMOs) to Improve Irritable Bowel Syndrome (IBS) Symptoms Through Targeting of the Gut Microbiota
There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS). Importantly, this enteric population is susceptible to dietary intervention and represents an exciting target for the prevention and treatment of gut mediated disorders. This study will investigate microbial components and activities associated with the gut microbiome, using a global systems biology approach to explore the capacity of a human milk carbohydrate intervention in modulating this microbial community to target IBS, with the primary objective of improving IBS symptoms.
IBS is a highly prevalent gastrointestinal (GI) disorder with significant negative impact on quality of life of patients and high healthcare costs. Although prognosis of IBS is benign, it is a disorder that poses a considerable burden on the individual sufferer and society. Patients typically present with chronic abdominal pain and an altered bowel habit, frequently accompanied by bloating and distension. Often, IBS will afflict sufferers for life, with flares of activity followed by periods of remission. Incidence commonly peaks in the third and fourth decades of life.
Read more
IBS is suggested to be a disorder of gut-brain interaction, and alterations of the microbiota-host interactions at the mucosal border may cause symptoms such as those previously mentioned. Therefore, microbiota-targeted interventions may benefit some people with IBS by beneficially modulating the gut microbiome. Several studies have confirmed that prebiotics, such as galactooligosaccharides (GOS), are able to successfully stimulate gut bifidobacteria and alleviate symptoms in IBS. Prebiotics are defined as "a substrate that is selectively utilised by host microorganisms conferring a health benefit" [8]. These studies suggest that prebiotics may have potential as therapeutic agents in IBS.
Breastmilk is known to play a crucial role in the development of infants, providing key nutrients and immunological compounds important for initial protection against pathogens [9]. Among these compounds, human milk oligosaccharides (HMOs) represent the third most important component of breastmilk after lipids and lactose. HMOs have also been investigated for potential health benefits in adults, including their potential role as prebiotics for improved gut microbiota modulation.
Studies looking specifically at HMO interventions in humans with IBS are sparse. These include a phase II, parallel, RCT in 58 IBS volunteers by Iribarren et al. and an open-label trial with 245 IBS participants from 17 sites across USA by Palsson et al.. None have been sufficiently powered to a degree which could influence clinical practice, but crucially tolerability and safety profiles of HMOs investigated, to date, have been consistently high.
Using the global systems biology approach not yet applied to this research question, a pre-competitive approach to selecting a candidate HMO, and a crossover feasibility trial design, the investigators hope to forge a new direction in establishing the merits of HMO use in IBS.
This study will look specifically at patients with all IBS subtypes, an area where there is a real therapeutic gap and clinical need for safe, effective therapy to improve quality of life. Participants will be randomly allocated to be given either the HMO or a placebo, with neither the patient nor the researchers knowing which they are receiving (randomised and double blind design). They will take this HMO or placebo for 28 days (randomly distributed), and then stop taking it in a 'washout' period of 28 days, allowing the gut microbiota to return to baseline. Then, the participants will take the other intervention (placebo or prebiotic, whichever they did not take in the first half of the study) for 28 days, then have a further washout period of 14 days. The study will then be over.
With this proposal, the aim is to explore how HMOs affect the gut microbiota and whether they can do so in a manner that positively influences patients with IBS. The investigators also hope to develop molecular profiling as part of a research toolkit for gut microbiome-based HMO supplement studies.
Read the detailed description
The hypothesis of this study is that dietary supplementation with human milk oligosaccharides (HMO) will result in clinically significant improvement in IBS symptoms compared to placebo.
The null hypothesis is that HMO supplementation will have no different effect on disease activity compared to placebo. The alterative hypothesis is that HMO supplementation may worsen disease activity.
In this crossover design trial, patient reported outcome measures will be collected before, during and after both the intervention and placebo periods and compared.
With respect to secondary outcomes, this trial will also seek to identify if the HMO causes a reduction in anxiety and depression (measured and scored using validated questionnaire, PHQ-ADS), improvement in sleep quality (measured through Pittsburgh Sleep Quality Index, PSQI validated questionnaire), and changes in faecal microbiota (using 16S rRNA sequencing of key bacterial populations, e.g. bifidobacteria), changes in stool bacterial metabolites (measured as change in stool SCFA levels).
This is a 16-week, randomised, placebo-controlled, double-blinded crossover trial. The investigators aim to recruit 44 participants with IBS. These participants will be screened and classified into a particular IBS subtype. After a 14-day baseline period, participants will be randomised to orally consume either 5g of HMO for 28 days, or a placebo for 28 days. This will be administered at the University of Reading. All participants will then stop taking the product for 28 days (wash out period) and then swap treatment type and have 28 days of either placebo or HMO. This is then followed by another 14 days without any product. During the study, participants will be asked to complete a 24-hour food recall weeks 0 and 16. Additionally, participants will complete validated questionnaires (IBS-Symptom Severity Score, anxiety and depression score and Pittsburgh Sleep Quality Index (PSQI) every time they provide urine and faecal samples at each visit. All samples will be analysed at the University of Reading with the exception of 16S rRNA sequencing (patient data anonymised) which will be carried out by collaborators in Switzerland.
Collection and data analysis of questionnaire data will be carried out at The University of Reading.
1H-NMR spectroscopy-based metabolic profiling studies: In this proposal, 1H-NMR spectroscopy will be applied to characterise global metabolic signatures from biological samples collected throughout the human trials, using standard one-dimensional NMR experiments. Gut microbiology and metabonomic data will be integrated using data fusion techniques (for example, bidirectional partial least squares multi-block data analysis) to generate mechanistic understanding of system-level changes and optimise extraction of clinically relevant molecular information. It is anticipated that this analysis will provide a measure of how prebiotic based intervention during the clinical trial has affected the human metabonome in a manner closer to 'health.' Data collected will be bacterial community profiles, volunteer questionnaires, NMR-based metabonomic data, microbial end products and patient symptoms. These data will mostly be numerical and in the form of Excel spreadsheets, but will also include spectra data files, raw sequence files and food diary records (MS word/REDCap). Software for data analysis will be SAS (Statistical Analysis Software). Only the metabonomic NMR spectroscopy and microbial sequencing data files will generate moderately large data volumes. The investigators will identify community standards for data formatting for eventual deposit in data repositories.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Human milk oligosaccharide, Maltodextrin placebo
- Keywords
- Gut microbiome, IBS, Human milk oligosaccharides
- 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.
Human milk oligosaccharideDietary supplement
Also called HMOs
5g daily dose of HMOs.
Maltodextrin placeboDietary supplement
Also called Placebo
5g daily dose of maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control arm | Placebo comparator | Maltodextrin will be given as a white powder placebo for 4 weeks. Receives: Dietary Supplement: Maltodextrin placebo |
| HMO intervention arm | Experimental | HMOs will be given as a white powder for 4 weeks. Receives: Dietary Supplement: Human milk oligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-SSS
Irritable Bowel Syndrome Symptom Severity Score validated questionnaire. Each measure is rated from 0 to 100, with total scores ranging from 0 to 500.
Measured: Clinically significant improvement in patient symptoms as defined by a decrease in IBS-symptom severity scoring over 16-week trial duration.
Secondary outcomes (3)
Change in anxiety and depression scores (ADS)
Measured and scored using validated questionnaire, PHQ-ADS. The PHQ-ADS is the sum of the PHQ-9 and GAD-7 scores and thus can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.
Measured: Over 16-week trial duration.
Improvement of the Pittsburgh Sleep Quality Index (PSQI).
A validated questionnaire measuring sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.
Measured: Over 16-week trial duration.
Changes in faecal microbiota e.g. Bifidobacterium
16S rRNA sequencing of key bacterial populations.
Measured: Over 16-week trial duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Feb 2024
- Primary completion20 Aug 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Crossover
- Model description
- This is a 16-week, randomised, placebo-controlled, double-blinded crossover trial. We aim to recruit 44 participants with IBS. These participants will be screened and classified into a particular IBS subtype. After a 14-day baseline period, participants will be randomised to orally consume either 5g of HMO for 28 days, or a placebo for 28 days. This will be administered at the University of Reading. All participants will then stop taking the product for 28 days (wash out period) and then swap treatment type and have 28 days of either placebo or HMO. This is then followed by another 14 days without any product. During the study, participants will be asked to complete a 24-hour food recall weeks 0 and 16. Additionally, participants will complete validated questionnaires (IBS-Symptom Severity Score, anxiety and depression score and Pittsburgh Sleep Quality Index (PSQI) every time they provide urine and faecal samples at each visit.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glenn Gibson
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Glenn Gibson, University of Reading
- Investigators
- Glenn Gibson, Prof., Study director, The University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281600
- Sponsor's protocol ID
- REC: 23/SW/0042
- Other IDs
- 326109
- Acronym
- GUT-HEAL-IBS
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanz Morales P, Wijeyesekera A, Robertson MD, Jackson PPJ, Gibson GR. The Potential Role of Human Milk Oligosaccharides in Irritable Bowel Syndrome. Microorganisms. 2022 Nov 25;10(12):2338. doi: 10.3390/microorganisms10122338.
PubMed 36557589
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Crossover Intervention Study Using Human Milk Oligosaccharides (HMOs) to Improve Irritable Bowel Syndrome (IBS) Symptoms Through Targeting of the Gut Microbiota
- ClinicalTrials.gov ID
- NCT06281600
- Acronym / sponsor ID
- GUT-HEAL-IBS / REC: 23/SW/0042
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Gut microbiome, IBS, Human milk oligosaccharides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Glenn GibsonUniversity, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 28 Feb 2024 (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.
There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS). Importantly, this enteric population is susceptible to dietary intervention and represents an exciting target for the prevention and treatment of gut mediated disorders. This study will investigate microbial components and activities associated with the gut microbiome, using a global systems biology approach to explore the capacity of a human milk carbohydrate intervention in modulating this microbial community to target IBS, with the primary objective of improving IBS symptoms.
IBS is a highly prevalent gastrointestinal (GI) disorder with significant negative impact on quality of life of patients and high healthcare costs. Although prognosis of IBS is benign, it is a disorder that poses a considerable burden on the individual sufferer and society. Patients typically present with chronic abdominal pain and an altered bowel habit, frequently accompanied by bloating and distension. Often, IBS will afflict sufferers for life, with flares of activity followed by periods of remission. Incidence commonly peaks in the third and fourth decades of life.
IBS is suggested to be a disorder of gut-brain interaction, and alterations of the microbiota-host interactions at the mucosal border may cause symptoms such as those previously mentioned. Therefore, microbiota-targeted interventions may benefit some people with IBS by beneficially modulating the gut microbiome. Several studies have confirmed that prebiotics, such as galactooligosaccharides (GOS), are able to successfully stimulate gut bifidobacteria and alleviate symptoms in IBS. Prebiotics are defined as "a substrate that is selectively utilised by host microorganisms conferring a health benefit" [8]. These studies suggest that prebiotics may have potential as therapeutic agents in IBS.
Breastmilk is known to play a crucial role in the development of infants, providing key nutrients and immunological compounds important for initial protection against pathogens [9]. Among these compounds, human milk oligosaccharides (HMOs) represent the third most important component of breastmilk after lipids and lactose. HMOs have also been investigated for potential health benefits in adults, including their potential role as prebiotics for improved gut microbiota modulation.
Studies looking specifically at HMO interventions in humans with IBS are sparse. These include a phase II, parallel, RCT in 58 IBS volunteers by Iribarren et al. and an open-label trial with 245 IBS participants from 17 sites across USA by Palsson et al.. None have been sufficiently powered to a degree which could influence clinical practice, but crucially tolerability and safety profiles of HMOs investigated, to date, have been consistently high.
Using the global systems biology approach not yet applied to this research question, a pre-competitive approach to selecting a candidate HMO, and a crossover feasibility trial design, the investigators hope to forge a new direction in establishing the merits of HMO use in IBS.
This study will look specifically at patients with all IBS subtypes, an area where there is a real therapeutic gap and clinical need for safe, effective therapy to improve quality of life. Participants will be randomly allocated to be given either the HMO or a placebo, with neither the patient nor the researchers knowing which they are receiving (randomised and double blind design). They will take this HMO or placebo for 28 days (randomly distributed), and then stop taking it in a 'washout' period of 28 days, allowing the gut microbiota to return to baseline. Then, the participants will take the other intervention (placebo or prebiotic, whichever they did not take in the first half of the study) for 28 days, then have a further washout period of 14 days. The study will then be over.
With this proposal, the aim is to explore how HMOs affect the gut microbiota and whether they can do so in a manner that positively influences patients with IBS. The investigators also hope to develop molecular profiling as part of a research toolkit for gut microbiome-based HMO supplement studies.
Detailed description
The hypothesis of this study is that dietary supplementation with human milk oligosaccharides (HMO) will result in clinically significant improvement in IBS symptoms compared to placebo.
The null hypothesis is that HMO supplementation will have no different effect on disease activity compared to placebo. The alterative hypothesis is that HMO supplementation may worsen disease activity.
In this crossover design trial, patient reported outcome measures will be collected before, during and after both the intervention and placebo periods and compared.
With respect to secondary outcomes, this trial will also seek to identify if the HMO causes a reduction in anxiety and depression (measured and scored using validated questionnaire, PHQ-ADS), improvement in sleep quality (measured through Pittsburgh Sleep Quality Index, PSQI validated questionnaire), and changes in faecal microbiota (using 16S rRNA sequencing of key bacterial populations, e.g. bifidobacteria), changes in stool bacterial metabolites (measured as change in stool SCFA levels).
This is a 16-week, randomised, placebo-controlled, double-blinded crossover trial. The investigators aim to recruit 44 participants with IBS. These participants will be screened and classified into a particular IBS subtype. After a 14-day baseline period, participants will be randomised to orally consume either 5g of HMO for 28 days, or a placebo for 28 days. This will be administered at the University of Reading. All participants will then stop taking the product for 28 days (wash out period) and then swap treatment type and have 28 days of either placebo or HMO. This is then followed by another 14 days without any product. During the study, participants will be asked to complete a 24-hour food recall weeks 0 and 16. Additionally, participants will complete validated questionnaires (IBS-Symptom Severity Score, anxiety and depression score and Pittsburgh Sleep Quality Index (PSQI) every time they provide urine and faecal samples at each visit. All samples will be analysed at the University of Reading with the exception of 16S rRNA sequencing (patient data anonymised) which will be carried out by collaborators in Switzerland.
Collection and data analysis of questionnaire data will be carried out at The University of Reading.
1H-NMR spectroscopy-based metabolic profiling studies: In this proposal, 1H-NMR spectroscopy will be applied to characterise global metabolic signatures from biological samples collected throughout the human trials, using standard one-dimensional NMR experiments. Gut microbiology and metabonomic data will be integrated using data fusion techniques (for example, bidirectional partial least squares multi-block data analysis) to generate mechanistic understanding of system-level changes and optimise extraction of clinically relevant molecular information. It is anticipated that this analysis will provide a measure of how prebiotic based intervention during the clinical trial has affected the human metabonome in a manner closer to 'health.' Data collected will be bacterial community profiles, volunteer questionnaires, NMR-based metabonomic data, microbial end products and patient symptoms. These data will mostly be numerical and in the form of Excel spreadsheets, but will also include spectra data files, raw sequence files and food diary records (MS word/REDCap). Software for data analysis will be SAS (Statistical Analysis Software). Only the metabonomic NMR spectroscopy and microbial sequencing data files will generate moderately large data volumes. The investigators will identify community standards for data formatting for eventual deposit in data repositories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 16-week, randomised, placebo-controlled, double-blinded crossover trial. We aim to recruit 44 participants with IBS. These participants will be screened and classified into a particular IBS subtype. After a 14-day baseline period, participants will be randomised to orally consume either 5g of HMO for 28 days, or a placebo for 28 days. This will be administered at the University of Reading. All participants will then stop taking the product for 28 days (wash out period) and then swap treatment type and have 28 days of either placebo or HMO. This is then followed by another 14 days without any product. During the study, participants will be asked to complete a 24-hour food recall weeks 0 and 16. Additionally, participants will complete validated questionnaires (IBS-Symptom Severity Score, anxiety and depression score and Pittsburgh Sleep Quality Index (PSQI) every time they provide urine and faecal samples at each visit.
| Arm | Type | Receives |
|---|---|---|
| Placebo control arm | Placebo comparator | Dietary Supplement: Maltodextrin placeboMaltodextrin will be given as a white powder placebo for 4 weeks. |
| HMO intervention arm | Experimental | Dietary Supplement: Human milk oligosaccharideHMOs will be given as a white powder for 4 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed consent form.
- Adults (aged from 18 to 60).
- Diagnosis of irritable bowel syndrome by a clinician (according to the Rome IV criteria).
- Absence of gut conditions other than IBS.
Key exclusion criteria (6 listed)
- Intake of an experimental drug within four weeks prior to study.
- Former participation in prebiotic, probiotic or laxative trials within the previous four weeks.
- Former participation in a dietary intervention within the previous four weeks.
- Use of antibiotics within the previous four weeks.
- Intake of other specific prebiotics (such as oligosaccharides e.g. inulin), or probiotics (e.g. live yoghurts, other fermented products), drugs active on gastrointestinal motility, or a laxative of any class, for four weeks prior to study.
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 |
|---|---|---|
| Human milk oligosaccharideAlso: HMOs5g daily dose of HMOs. | Dietary supplement | HMO intervention arm |
| Maltodextrin placeboAlso: Placebo5g daily dose of maltodextrin. | Dietary supplement | Placebo control arm |
Primary outcome
IBS-SSS
Time frame: Clinically significant improvement in patient symptoms as defined by a decrease in IBS-symptom severity scoring over 16-week trial duration.
Irritable Bowel Syndrome Symptom Severity Score validated questionnaire. Each measure is rated from 0 to 100, with total scores ranging from 0 to 500.
3 secondary outcomes
Change in anxiety and depression scores (ADS)
Time frame: Over 16-week trial duration.
Improvement of the Pittsburgh Sleep Quality Index (PSQI).
Time frame: Over 16-week trial duration.
Changes in faecal microbiota e.g. Bifidobacterium
Time frame: Over 16-week trial duration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 36557589Sanz Morales P, Wijeyesekera A, Robertson MD, Jackson PPJ, Gibson GR. The Potential Role of Human Milk Oligosaccharides in Irritable Bowel Syndrome. Microorganisms. 2022 Nov 25;10(12):2338. doi: 10.3390/microorganisms10122338.
- Individual participant dataSharing planned: No
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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.
Glenn Gibson, Prof. study director
The University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human milk oligosaccharide in people with Irritable Bowel Syndrome, run by Glenn Gibson at 1 site in United Kingdom.
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 4 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Sanz Morales (+447843865554, p.sanzmorales@pgr.reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS-SSS (time frame: Clinically significant improvement in patient symptoms as defined by a decrease in IBS-symptom severity scoring over 16-week trial duration.). 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 NCT06281600, which also lists 1 linked publication.
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 29 Feb 2024.