Irritable Bowel SyndromeEGISNCT05157061
GOS to Reduce Symptom Severity in IBS
A study testing Galacto-oligosaccharides (GOS) and Maltodextrine in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome - Constipation, run by Clasado at 9 sites in 3 countries.
Trial summary
IBS is a highly prevalent bowel disorder, characterized by recurrent abdominal pain during bowel movements or a change in bowel habits. Typically, IBS patients experience constipation, diarrhoea or a mix of constipation and diarrhoea, as well as symptoms of abdominal bloating or distension. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation, Irritable Bowel Syndrome - Diarrhoea
- What is being tested?
- Galacto-oligosaccharides (GOS) and Maltodextrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 26 Oct 2021to 6 Aug 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed with IBS by a medically trained person/Health Care Professional (HCP).
- IBS diagnosis to be confirmed according to the Rome-IV criteria by a primary or secondary care clinician, including a gastroenterologist, at study entry
- An IBS Symptom Severity Scale score of ≥125 points at baseline
- Male or female between 18 and 64 years of age (age ranges included)
- Possession of a smartphone
- Willing and eligible to provide consent and comply with protocol and product intake.
Who cannot join
- Unclassifiable IBS (IBS-U) as determined by Investigator
- Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeks prior to study entry (e.g. Yakult, Actimel, Activia, VSL#3, Kefir).
- o Regular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion.
- Systemic antibiotic or antimycotic treatment within 4 weeks prior to study entry
- Use of laxatives or antidiarrheal medication within 1 week prior to study entry
- An unstable antidepressant/antipsychotic treatment regimen within 3 months prior to study entry (i.e. treatment should be stable for at least 3 months prior to study entry).
Show all 22Show fewer
- Confirmed lactose intolerance, defined as patients who report response to dietary elimination of lactose/dairy products. Confirmation is patient-reported and not done within the scope of this study.
- Confirmed food allergy, with reported confirmation based on OFC, IgE, or skin prick test. Confirmation is patient-reported and not done within the scope of this study.
- Galactosemia (galactose metabolism disorder)
- Following diets likely to affect study outcomes, including:
- o low FODMAP, KETO/high-fat, gluten free/coeliac, paleo, weight loss, caloric restriction, low-carb, 5:2/whole day energy restriction, Atkins/high-protein, sugar-free, single-food, juicing/any day of juicing, any other restriction diet (e.g. very low calory), or vegan diets (GOS is derived from cow's milk).
- Severe illness(es) or medical condition(s), including gastrointestinal pathologies:
- o GI ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowel resection, , bariatric surgery, acute or chronic diarrhoea secondary to confirmed infectious gastroenteritis, or enteral or parenteral nutrition.
- Subjects suffering from auto-immune disorders (e.g. Rheumatoid Arthritis, Systemic lupus erythematosus, Multiple Sclerosis, Graves' Disease) that require treatment with an immune modulator treatment or anti-inflammatory medication
- Surgical operations to the mouth or gastrointestinal tract within 4 weeks prior to study entry, or planned during the study
- o Appendectomy within 6 months prior to study entry
- Recent unintended weight loss:
- o >5% of total body weight within 6 months prior to study entry
- Excessive alcohol consumption (>14 units per week) and/or drug abuse
- Pregnancy and lactation, or plan to become pregnant during the study period
- Participation in other studies involving investigational or marketed products concomitantly or within 3 months prior to study entry
- Changes in diet, supplement or medication use likely to affect study outcomes (i.e. medication that influences GI function) within 4 weeks prior to study entry or planned during the study (at the discretion of the Investigator). For example, the following medications will influence GI function and changes must be avoided: opioids, prokinetics (domperidone, metoclopramide, prucalopride), antispasmodics (peppermint oil, buscopan), and acid suppressants (PPI, H2 blockers). Of note: the intake of fibres (e.g. psyllium husk) may be used provided that the participant has been using this as a supplement for more than 4 weeks prior to study participation and intake does not change during the course of participation.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United Kingdom5 sites
County Durham &Darlington NHS Foundation trust, University Hospital of North Durham
Durham, DH1 5TW
Leeds Teaching Hospital NHS Trust in association with the University of Leeds
Leeds, North Yorkshire, LS9 7TF
Barts Health NHS Trust, Wingate Clinical Trials Facility
London, E1 2AJ
Manchester University NHS Foundation Trust, Wythenshawe Hospital, Neurogastroenterology Unit
Manchester, M23 9LT
NIHR National Patient Recruitment Centre Newcastle
Newcastle upon Tyne, NE4 6BE
Netherlands3 sites
Jeroen Bosch Ziekenhuis, Gastroenterology department
's-Hertogenbosch, North Brabant, 5223GZ
Ziekenhuis Gelderse Vallei, Afdeling Maag-Darm-Leverziekten
Ede, 6716 RP
Medisch Centrum Leeuwarden (MCL)
Leeuwarden, Provincie Friesland, 8934AD
About this study
Official title: A Multi-centre, Randomized, Placebo-Controlled, Efficacy Study of Prebiotic Galacto-oligosaccharides on Gastrointestinal Symptom Severity in Patients With Irritable Bowel Syndrome
IBS is a highly prevalent bowel disorder, characterized by recurrent abdominal pain during bowel movements or a change in bowel habits. Typically, IBS patients experience constipation, diarrhoea or a mix of constipation and diarrhoea, as well as symptoms of abdominal bloating or distension. The chronic and bothersome nature of IBS symptoms negatively affects the quality of life of many patients. Because there are currently limited medical treatment options for IBS, it is important to study new treatments.
IBS can (in part) be caused by an 'imbalance' of the bacteria residing in the intestinal tract. For instance, there may be a lower proportion of specific bacteria that are generally considered beneficial for a persons health. The consumption of non-digestible food ingredients, such as GOS, may stimulate the growth of these beneficial bacteria. GOS is a type of 'prebiotic', which is known to support health and wellbeing of consumers. By restoring the bacterial balance of the intestinal tract, the symptoms of IBS may be reduced after consumption of GOS.
Read more
The health effects of the study product (a specific GOS) used in current study was previously investigated in a small group of patients with IBS. Use of the study product indicated a reduction in the patients' symptoms, improvement in the patients' quality of life, and changes in patients' gut bacteria. It is therefore hypothesized that GOS / a specific GOS may reduce the symptom severity of patients with IBS.
This study further evaluates how GOS may improve symptoms of IBS.
Read the detailed description
A Phase III, randomized, double-blind, placebo-controlled, multi-centre, 8-week intervention study, preceded by a 2-week run-in period, to assess the efficacy of GOS on symptom severity in adult patients with IBS. The study population will consist of 210 adult patients diagnosed in the past 36 months with IBS-Diarrhoea (N =70), IBS-Constipation (N = 70), or IBS-Mixed (N =70).
Irritable bowel syndrome (IBS) is a highly prevalent and multifaceted functional bowel disorder characterized by recurrent abdominal pain associated with defecation or a change in bowel habits in the absence of detectable structural and biochemical abnormalities. Disordered bowel habits are typically present, such as constipation, diarrhoea or a mix of constipation and diarrhoea, as are symptoms of abdominal bloating/distension. The chronic and bothersome nature of IBS symptoms negatively affects patients' quality of life and introduces a substantial economic burden on patients and the healthcare system. The gut microbiota composition and function may play a pivotal role in the pathogenesis of IBS, as a reduction in endogenous bifidobacteria, lactobacilli, and Faecalibacterium prausnitzii concentrations, as well as small bowel bacterial overgrowth have been reported in IBS patients, thereby introducing the gut microbiota as a potential target for treatment and symptom relief. Intervention with non-digestible food ingredients, such as galacto-oligosaccharides (GOS), may form a suitable intervention strategy, as these 'prebiotics' are known to modulate the gastrointestinal (GI) microbiota and support health and wellbeing of the host.
The safety and efficacy of GOS has previously been evaluated in patients with IBS, which demonstrated that GOS may reduce IBS symptom severity, improve quality of life, improve stool consistency and defecation frequency and alter gut microbiota composition, in a safe manner.
As there are currently limited suitable medical treatments for IBS, this study will evaluate the efficacy of GOS in reducing symptom severity of patients with IBS
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation, Irritable Bowel Syndrome - Diarrhoea, Irritable Bowel Syndrome - Mixed
- Being tested
- Galacto-oligosaccharides (GOS), Maltodextrine
- Keywords
- Irritable Bowel Syndrome, Diarrhoea, Constipation, Galacto-oligosaccharides (GOS), Symptom severity, Prebiotic, Supplement, Rome IV Criteria
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galacto-oligosaccharides (GOS)Dietary supplement
Also called Prebiotic
An 8-week intervention study, preceded by a 2-week run-in period, in which a daily dose of a prebiotic supplement is given to adult patients diagnosed with IBS (diarrhoea, constipation or mixed-type). Patients need to report several symptom experiences and blood and faecal samples are collected.
MaltodextrineDietary supplement
Also called Placebo
An 8-week intervention study, preceded by a 2-week run-in period, in which a daily dose of a placebo is given to adult patients diagnosed with IBS (diarrhoea, constipation or mixed-type). Patients need to report several symptom experiences and blood and faecal samples are collected.
| Study group | Role | What they receive |
|---|---|---|
| GOS arm | Experimental | A single daily dose of a food supplement containing GOS for 8 weeks Receives: Dietary Supplement: Galacto-oligosaccharides (GOS) |
| Placebo arm | Placebo comparator | A single daily dose of maltodextrin, matching in taste, smell, appearance, and solubility, but without active ingredients (i.e. GOS), for 8 weeks Receives: Dietary Supplement: Maltodextrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS symptom Severity
The difference in total IBS symptom severity between treatment arms as measured by mean composite IBS Symptom Severity Scale scores. The IBS System Severity Scores Scale consists of 5 questions each with scales ranging from 0 to 100, divided into steps of 10, whereby a score of 0 reflects the best outcome, and a score of 100 reflects the worst outcome.
Measured: Baseline to end of the study (Day 56).
Secondary outcomes (9)
Abdominal pain
The difference in abdominal pain between treatment groups as measured by the mean abdominal pain symptom scores as reported by patients in their electronic diaries. Patients are requested to rate their worst abdominal pain over the past 24 hours on a scale from 0 = no abdominal pain, 10 = worst possible abdominal pain.
Measured: During the intervention period (8 weeks)
Bloating.
The difference in bloating between treatment groups as measured by the mean bloating symptom scores as reported by patients in their electronic diaries. Patients are requested to to rate their worst bloating symptoms over the past 24 hours, on a scale from 0 = no bloating, 10 = worst possible bloating.
Measured: During the intervention period (8 weeks)
Global IBS improvement
The difference in global IBS improvement between treatment arms as measured by the mean IBS Global Improvement Scale scores. Patients are requested to rate their IBS signs or symptoms overall over the past 7 days on a scale from 1 = significantly relieved to 7 = significantly worse.
Measured: During the intervention period (8 weeks)
Stool consistency
The difference in stool consistency between treatment arms, per subtype of IBS**, as measured by the median Bristol Stool Form Scale stool type. The Bristol Stool Form Scale stool types vary from 1 (separate hard lumps) to 7 (watery, no hard pieces). Normal stools would be rated in the middle of this scale (3, 4, or 5)
Measured: During the intervention period (8 weeks)
Defecation frequency
The difference in defecation frequency between treatment arms, per subtype of IBS**, as measured by the mean patient-reported defecation frequency.
Measured: During the intervention period (8 weeks)
Quality of Life IBS-QOL score
The difference in quality of life between treatment arms as measured by the mean composite IBS Quality of Life scores. The IBS Quality of Life validated questionnaire offers patients 34 statements concerning bowel problems (Irritable Bowel Syndrome, IBS) and how these affected the patient over the past 30 days, Scores range from 1 (not at all) to 5 (extremely)
Measured: At the end of the study (Day 56)
Anxiety and depression
The difference in anxiety and depression between treatment arms, evaluated separately using the mean IBS Hospital Anxiety and Depression Scale scores. The Hospital Anxiety and Depression scale asks patients to rate how they feel in 14 questions, each offering 4 different outcomes ranging from the best possible feeling to worst possible feeling
Measured: At the end of the study (Day 56)
Nature, incidence, frequency, severity of adverse events/serious adverse events and relationship to the study intervention.
To assess the safety of treatment with GOS in patients with IBS
Measured: During the intervention period (8 weeks)
Rescue medication
Difference in use of rescue medication between treatment arms
Measured: From screening to end of intervention period (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start26 Oct 2021
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase III, randomized, double-blind, placebo-controlled, multi-centre, 8-week intervention study, preceded by a 2-week run-in period, to assess the efficacy of GOS on symptom severity in adult patients with IBS.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clasado
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CR2O B.V.
- Responsible party
- Sponsor
- Investigators
- Lucien F. Harthoorn, PhD., Study director, Clasado Research Services Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157061
- Sponsor's protocol ID
- EGIS-01
- Acronym
- EGIS
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2021
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Placebo-Controlled, Efficacy Study of Prebiotic Galacto-oligosaccharides on Gastrointestinal Symptom Severity in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05157061
- Acronym / sponsor ID
- EGIS / EGIS-01
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation, Irritable Bowel Syndrome - Diarrhoea, Irritable Bowel Syndrome - Mixed
- Keywords
- Irritable Bowel Syndrome, Diarrhoea, Constipation, Galacto-oligosaccharides (GOS), Symptom severity, Prebiotic, Supplement, Rome IV Criteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- ClasadoIndustry (pharma, biotech, devices)
- Collaborators
- CR2O B.V.
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 14 Dec 2021 (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.
IBS is a highly prevalent bowel disorder, characterized by recurrent abdominal pain during bowel movements or a change in bowel habits. Typically, IBS patients experience constipation, diarrhoea or a mix of constipation and diarrhoea, as well as symptoms of abdominal bloating or distension. The chronic and bothersome nature of IBS symptoms negatively affects the quality of life of many patients. Because there are currently limited medical treatment options for IBS, it is important to study new treatments.
IBS can (in part) be caused by an 'imbalance' of the bacteria residing in the intestinal tract. For instance, there may be a lower proportion of specific bacteria that are generally considered beneficial for a persons health. The consumption of non-digestible food ingredients, such as GOS, may stimulate the growth of these beneficial bacteria. GOS is a type of 'prebiotic', which is known to support health and wellbeing of consumers. By restoring the bacterial balance of the intestinal tract, the symptoms of IBS may be reduced after consumption of GOS.
The health effects of the study product (a specific GOS) used in current study was previously investigated in a small group of patients with IBS. Use of the study product indicated a reduction in the patients' symptoms, improvement in the patients' quality of life, and changes in patients' gut bacteria. It is therefore hypothesized that GOS / a specific GOS may reduce the symptom severity of patients with IBS.
This study further evaluates how GOS may improve symptoms of IBS.
Detailed description
A Phase III, randomized, double-blind, placebo-controlled, multi-centre, 8-week intervention study, preceded by a 2-week run-in period, to assess the efficacy of GOS on symptom severity in adult patients with IBS. The study population will consist of 210 adult patients diagnosed in the past 36 months with IBS-Diarrhoea (N =70), IBS-Constipation (N = 70), or IBS-Mixed (N =70).
Irritable bowel syndrome (IBS) is a highly prevalent and multifaceted functional bowel disorder characterized by recurrent abdominal pain associated with defecation or a change in bowel habits in the absence of detectable structural and biochemical abnormalities. Disordered bowel habits are typically present, such as constipation, diarrhoea or a mix of constipation and diarrhoea, as are symptoms of abdominal bloating/distension. The chronic and bothersome nature of IBS symptoms negatively affects patients' quality of life and introduces a substantial economic burden on patients and the healthcare system. The gut microbiota composition and function may play a pivotal role in the pathogenesis of IBS, as a reduction in endogenous bifidobacteria, lactobacilli, and Faecalibacterium prausnitzii concentrations, as well as small bowel bacterial overgrowth have been reported in IBS patients, thereby introducing the gut microbiota as a potential target for treatment and symptom relief. Intervention with non-digestible food ingredients, such as galacto-oligosaccharides (GOS), may form a suitable intervention strategy, as these 'prebiotics' are known to modulate the gastrointestinal (GI) microbiota and support health and wellbeing of the host.
The safety and efficacy of GOS has previously been evaluated in patients with IBS, which demonstrated that GOS may reduce IBS symptom severity, improve quality of life, improve stool consistency and defecation frequency and alter gut microbiota composition, in a safe manner.
As there are currently limited suitable medical treatments for IBS, this study will evaluate the efficacy of GOS in reducing symptom severity of patients with IBS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase III, randomized, double-blind, placebo-controlled, multi-centre, 8-week intervention study, preceded by a 2-week run-in period, to assess the efficacy of GOS on symptom severity in adult patients with IBS.
| Arm | Type | Receives |
|---|---|---|
| GOS arm | Experimental | Dietary Supplement: Galacto-oligosaccharides (GOS)A single daily dose of a food supplement containing GOS for 8 weeks |
| Placebo arm | Placebo comparator | Dietary Supplement: MaltodextrineA single daily dose of maltodextrin, matching in taste, smell, appearance, and solubility, but without active ingredients (i.e. GOS), for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have been diagnosed with IBS by a medically trained person/Health Care Professional (HCP).
- IBS diagnosis to be confirmed according to the Rome-IV criteria by a primary or secondary care clinician, including a gastroenterologist, at study entry
- An IBS Symptom Severity Scale score of ≥125 points at baseline
- Male or female between 18 and 64 years of age (age ranges included)
- Possession of a smartphone
Key exclusion criteria (22 listed)
- Unclassifiable IBS (IBS-U) as determined by Investigator
- Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeks prior to study entry (e.g. Yakult, Actimel, Activia, VSL#3, Kefir).
- o Regular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion.
- Systemic antibiotic or antimycotic treatment within 4 weeks prior to study entry
- Use of laxatives or antidiarrheal medication within 1 week prior to study entry
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 |
|---|---|---|
| Galacto-oligosaccharides (GOS)Also: PrebioticAn 8-week intervention study, preceded by a 2-week run-in period, in which a daily dose of a prebiotic supplement is given to adult patients diagnosed with IBS (diarrhoea, constipation or mixed-type). Patients need to report several symptom experiences and blood and faecal samples are collected. | Dietary supplement | GOS arm |
| MaltodextrineAlso: PlaceboAn 8-week intervention study, preceded by a 2-week run-in period, in which a daily dose of a placebo is given to adult patients diagnosed with IBS (diarrhoea, constipation or mixed-type). Patients need to report several symptom experiences and blood and faecal samples are collected. | Dietary supplement | Placebo arm |
Primary outcome
IBS symptom Severity
Time frame: Baseline to end of the study (Day 56).
The difference in total IBS symptom severity between treatment arms as measured by mean composite IBS Symptom Severity Scale scores. The IBS System Severity Scores Scale consists of 5 questions each with scales ranging from 0 to 100, divided into steps of 10, whereby a score of 0 reflects the best outcome, and a score of 100 reflects the worst outcome.
9 secondary outcomes
Abdominal pain
Time frame: During the intervention period (8 weeks)
Bloating.
Time frame: During the intervention period (8 weeks)
Global IBS improvement
Time frame: During the intervention period (8 weeks)
Stool consistency
Time frame: During the intervention period (8 weeks)
Defecation frequency
Time frame: During the intervention period (8 weeks)
Quality of Life IBS-QOL score
Time frame: At the end of the study (Day 56)
Anxiety and depression
Time frame: At the end of the study (Day 56)
Nature, incidence, frequency, severity of adverse events/serious adverse events and relationship to the study intervention.
Time frame: During the intervention period (8 weeks)
Rescue medication
Time frame: From screening to end of intervention period (10 weeks)
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 18 Oct 2024.
- Individual participant dataSharing planned: No
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Irritable Bowel Syndrome (IBS)
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.
Lucien F. Harthoorn, PhD. study director
Clasado Research Services Limited
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galacto-oligosaccharides (GOS) and Maltodextrine in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome - Constipation, run by Clasado at 9 sites in 3 countries.
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 6 inclusion and 22 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 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Netherlands, Belgium. 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?
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?
IBS symptom Severity (time frame: Baseline to end of the study (Day 56).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024.