Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Effectiveness Study

An observational study of Irritable Bowel Syndrome, run by Karolinska Institutet.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main purpose of the study is to investigate the clinical real-world effectiveness of a specific exposure based psychological treatment for irritable bowel syndrome (IBS). A secondary aim of the study is to find mediators of the treatment effect and thereby learn something about the working mechanism of the… Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Irritable Bowel Syndrome
How many people: 319 participants
Where: No sites listed yet
Study dates: 1 Apr 2015to 31 Jan 2022
Phase: Observational
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All patients that were treated for IBS at the Internet psychiatry unit in Stockholm from the opening of the unit (april 2015) until january 2022. The study population is believed to be representative of Swedish IBS-patients that have undergone the first steps of treatment for IBS (i.e. life style counseling, dietary advice and tried various medications) but still suffer significantly from their symptoms.

Who may be able to join

Clinical diagnosis of IBS made by a licenced physician
Able to provide written certificate of the diagnosis
At least 16 years of age
Daily access to computer, mobile phone or tablet with internet
Account at health care guide 1177
Proficient in Swedish

Who cannot join

Considered having a high risk for suicide
Unable to read or communicate in written form
Do not understand Swedish language
has planned to be away for more than 2 weeks during the treatment period
suffers from another somatic or psychiatric condition needing to be prioritized or that might hinder treatment

About this study

Official title: The Effectiveness of Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Study

Read the detailed description

IBS is a debilitating disorder with a prevalence of 10% world wide. For patients with severe forms of IBS where medication and other interventions have failed it can be useful to try psychological treatment. National Institute for Health and Care Excellence (NICE) guidelines recommend cognitive behavior therapy or hypnotherapy.

Our research group at the Karolinska Institute in Stockholm has developed a cognitive behavioral treatment protocol for IBS. This treatment contains exposure therapy and mindfulness based exercises alongside psychoeducation. The treatment has been tested in four earlier randomized controlled trials (RCT) and produced large effect sizes compared to wait-list and moderate effect sizes compared to other active treatments or placebo.

The present study aims to examine the effectiveness of the treatment protocol under real-world circumstances at a secondary-care unit in Stockholm.

The Internet psychiatry Unit (IPSY) has been operative since 2007 and is run by Region Stockholm (i.e. the responsible authority for all publicly-funded healthcare in Stockholm). Patients with IBS have been treated at the clinic since 2015 and the treatment is delivered via an online treatment platform. The study is based on the clinics own data that has been collected for quality improvement reasons. Another aim of the study is to find out more about the working mechanisms behind the treatment by examining the weekly reports on behavioral avoidance and and anxiety that the patients file during treatment. All patients that have been treated at the clinic so far will be included in the study (N=319). Data has been collected between April 2015 and January 2022.

The study has an approved ethical permit from the Swedish Authority for Ethical Approvals.

The first hypothesis is that the treatment will be as effective in clinical routine care as it has been in earlier trials with a moderate to large effect-size from pre treatment to follow-up, six month after treatment. A second hypothesis is that the treatment effect is mediated by a change in behavioral avoidance that precedes symptomatic improvement.

Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome, Effectiveness, Cognitive Behavioral Therapy, Exposure, Internet, Mediation
Medical subject headings: Irritable Bowel Syndrome, Negotiating

What is being measured

The primary outcome is the main question the study is designed to answer.

The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 [17] and test-retest reliability between .55 and .70
Measured: pre treatment (same day as treatment starts),
Change from baseline IBS-symptoms measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 [17] and test-retest reliability between .55 and .70
Measured: weekly during treatment (ten times in total, during the ten week long treatment)
The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 [17] and test-retest reliability between .55 and .70
Measured: post treatment (same day as treatment ends). 10 weeks after treatment start.
The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 [17] and test-retest reliability between .55 and .70
Measured: follow-up (six months after the treatment ended),

Secondary outcomes (14)

The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
A scale measuring avoidance behavior and IBS-related anxiety'. The scale consists of 26 questions regarding food habits and toilet and social situations. The questions can be scored from 1-7 where 1 represents no control or avoidance behavior and 7 represents maximum avoidance or control, rendering a total score between 26 and 182. The IBS-BRQ has demonstrated excellent psychometric properties, with high internal consistency (Cronbach's alpha " .86) and high correlations with measures of dysfunctional IBS-related cognitions, IBS impact and impairment, anxiety, and depression
Measured: pre treatment (same day as treatment starts)
Change from baseline avoidance behaviors measured with The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
A scale measuring avoidance behavior and IBS-related anxiety'. The scale consists of 26 questions regarding food habits and toilet and social situations. The questions can be scored from 1-7 where 1 represents no control or avoidance behavior and 7 represents maximum avoidance or control, rendering a total score between 26 and 182. The IBS-BRQ has demonstrated excellent psychometric properties, with high internal consistency (Cronbach's alpha " .86) and high correlations with measures of dysfunctional IBS-related cognitions, IBS impact and impairment, anxiety, and depression
Measured: weekly during treatment (ten times in total, during the ten week long treatment)
The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
A scale measuring avoidance behavior and IBS-related anxiety'. The scale consists of 26 questions regarding food habits and toilet and social situations. The questions can be scored from 1-7 where 1 represents no control or avoidance behavior and 7 represents maximum avoidance or control, rendering a total score between 26 and 182. The IBS-BRQ has demonstrated excellent psychometric properties, with high internal consistency (Cronbach's alpha " .86) and high correlations with measures of dysfunctional IBS-related cognitions, IBS impact and impairment, anxiety, and depression
Measured: post treatment (same day as treatment ends), ten weeks after treatment start
The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
A scale measuring avoidance behavior and IBS-related anxiety'. The scale consists of 26 questions regarding food habits and toilet and social situations. The questions can be scored from 1-7 where 1 represents no control or avoidance behavior and 7 represents maximum avoidance or control, rendering a total score between 26 and 182. The IBS-BRQ has demonstrated excellent psychometric properties, with high internal consistency (Cronbach's alpha " .86) and high correlations with measures of dysfunctional IBS-related cognitions, IBS impact and impairment, anxiety, and depression
Measured: follow-up (six months after the treatment ended),
Visceral Sensitivity Index (VSI)
a scale designed to measure gastrointestinal specific anxiety (GSA; i.e., distress, avoidance, and safety behaviors in response to IBS-related stimuli). The VSI contains 15 items, which are scored between 0 and 5, rendering a total score between 0 (minimum GSA) and 75 (maximum GSA). The VSI has demonstrated high internal consistency (Cronbach's a = .90-.92) and has been shown to be associated with symptom severity and diagnostic status of IBS and also to be a mediator of the effect of exposure-based cognitive behavioral treatment on IBS symptoms
Measured: pre treatment (same day as treatment starts)
Visceral Sensitivity Index (VSI)
a scale designed to measure gastrointestinal specific anxiety (GSA; i.e., distress, avoidance, and safety behaviors in response to IBS-related stimuli). The VSI contains 15 items, which are scored between 0 and 5, rendering a total score between 0 (minimum GSA) and 75 (maximum GSA). The VSI has demonstrated high internal consistency (Cronbach's a = .90-.92) and has been shown to be associated with symptom severity and diagnostic status of IBS and also to be a mediator of the effect of exposure-based cognitive behavioral treatment on IBS symptoms
Measured: post treatment (same day as treatment ends), ten weeks after treatment start.
Visceral Sensitivity Index (VSI)
a scale designed to measure gastrointestinal specific anxiety (GSA; i.e., distress, avoidance, and safety behaviors in response to IBS-related stimuli). The VSI contains 15 items, which are scored between 0 and 5, rendering a total score between 0 (minimum GSA) and 75 (maximum GSA). The VSI has demonstrated high internal consistency (Cronbach's a = .90-.92) and has been shown to be associated with symptom severity and diagnostic status of IBS and also to be a mediator of the effect of exposure-based cognitive behavioral treatment on IBS symptoms
Measured: follow-up (six months after the treatment ended)
EuroQoL (EQ-5D)
The EQ-5D consists of two parts: the health states descriptive system and the visual analog rating scale (VAS). In our study we used only the VAS scale which can be rated from 0-100. The endpoints of the VAS are labeled "best imaginable health state" and "worst imaginable health state" anchored at 100 and 0, respectively.
Measured: pre treatment (same day as treatment starts)
EuroQoL (EQ-5D)
The EQ-5D consists of two parts: the health states descriptive system and the visual analog rating scale (VAS). In our study we used only the VAS scale which can be rated from 0-100. The endpoints of the VAS are labeled "best imaginable health state" and "worst imaginable health state" anchored at 100 and 0, respectively.
Measured: post treatment (same day as treatment ends), ten weeks after treatment start.
EuroQoL (EQ-5D)
The EQ-5D consists of two parts: the health states descriptive system and the visual analog rating scale (VAS). In our study we used only the VAS scale which can be rated from 0-100. The endpoints of the VAS are labeled "best imaginable health state" and "worst imaginable health state" anchored at 100 and 0, respectively.
Measured: follow-up (six months after the treatment ended)
Short Form Health Survey (SF-12)
This is a generic health status measure that includes both the physical domain and the mental domain of health. The scale has 12 items and has shown to be a reliable indicator of subjectively perceived health (Jenkinson C, et al., 1990).
Measured: pre treatment (same day as treatment starts)
Short Form Health Survey (SF-12)
This is a generic health status measure that includes both the physical domain and the mental domain of health. The scale has 12 items and has shown to be a reliable indicator of subjectively perceived health (Jenkinson C, et al., 1990).
Measured: post treatment (same day as treatment ends), ten weeks after treatment start.
Change from baseline health status measured with Short Form Health Survey (SF-12)
This is a generic health status measure that includes both the physical domain and the mental domain of health. The scale has 12 items and has shown to be a reliable indicator of subjectively perceived health (Jenkinson C, et al., 1990).
Measured: weekly during treatment (ten times in total, during the ten week long treatment)
Short Form Health Survey (SF-12)
This is a generic health status measure that includes both the physical domain and the mental domain of health. The scale has 12 items and has shown to be a reliable indicator of subjectively perceived health (Jenkinson C, et al., 1990).
Measured: follow-up (six months after the treatment ended)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201531 Jan 2022

First posted14 Apr 2022
Study start1 Apr 2015
Primary completion31 Jan 2022
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
More trials run by Karolinska InstitutetThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 319 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05328245
Sponsor's protocol ID: IPSY-IBS
Status last verified: Apr 2022
First submitted: 28 Mar 2022
Last updated: 14 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No individual participant data will be shared due to General Data Protection Regulation (GDPR). Researchers that want to share the data must apply for ethical permit from The Authority for Ethical Approvals in Sweden.

Publications

Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med. 1997 Jun;19(2):179-86. doi: 10.1093/oxfordjournals.pubmed.a024606.
PubMed 9243433
Wallen H, Ljotsson B, Lindfors P, Forsell E, Hesser H, Svanborg C. Internet-Delivered Exposure-Based Cognitive Behavior Therapy for Irritable Bowel Syndrome: A Clinical Effectiveness Study. Am J Gastroenterol. 2025 Apr 1;120(4):856-863. doi: 10.14309/ajg.0000000000003059. Epub 2024 Aug 28.
PubMed 39194012

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
Irritable Bowel Syndrome
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Not yet recruiting
NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)

All Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Study
ClinicalTrials.gov ID: NCT05328245
Acronym / sponsor ID: IPSY-IBS
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome, Effectiveness, Cognitive Behavioral Therapy, Exposure, Internet, Mediation
Study type: Observational
Recruitment status: Completed
Enrolment: 319 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Collaborators: Region Stockholm
Study start: 1 Apr 2015 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 14 Apr 2022 (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.

Detailed description

The present study aims to examine the effectiveness of the treatment protocol under real-world circumstances at a secondary-care unit in Stockholm.

The study has an approved ethical permit from the Swedish Authority for Ethical Approvals.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patients that were treated for IBS at the Internet psychiatry unit in Stockholm from the opening of the unit (april 2015) until january 2022. The study population is believed to be representative of Swedish IBS-patients that have undergone the first steps of treatment for IBS (i.e. life style counseling, dietary advice and tried various medications) but still suffer significantly from their symptoms.

Key inclusion criteria (6 listed)

Clinical diagnosis of IBS made by a licenced physician
Able to provide written certificate of the diagnosis
At least 16 years of age
Daily access to computer, mobile phone or tablet with internet
Account at health care guide 1177

Key exclusion criteria (5 listed)

Considered having a high risk for suicide
Unable to read or communicate in written form
Do not understand Swedish language
has planned to be away for more than 2 weeks during the treatment period
suffers from another somatic or psychiatric condition needing to be prioritized or that might hinder treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
Time frame: pre treatment (same day as treatment starts),
It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 [17] and test-retest reliability between .55 and .70
Change from baseline IBS-symptoms measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
Time frame: weekly during treatment (ten times in total, during the ten week long treatment)
It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 [17] and test-retest reliability between .55 and .70
The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
Time frame: post treatment (same day as treatment ends). 10 weeks after treatment start.
It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 [17] and test-retest reliability between .55 and .70
The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
Time frame: follow-up (six months after the treatment ended),
It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 [17] and test-retest reliability between .55 and .70

14 secondary outcomes

The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
Time frame: pre treatment (same day as treatment starts)
Change from baseline avoidance behaviors measured with The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
Time frame: weekly during treatment (ten times in total, during the ten week long treatment)
The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
Time frame: post treatment (same day as treatment ends), ten weeks after treatment start
The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
Time frame: follow-up (six months after the treatment ended),
Visceral Sensitivity Index (VSI)
Time frame: pre treatment (same day as treatment starts)
Visceral Sensitivity Index (VSI)
Time frame: post treatment (same day as treatment ends), ten weeks after treatment start.
Visceral Sensitivity Index (VSI)
Time frame: follow-up (six months after the treatment ended)
EuroQoL (EQ-5D)
Time frame: pre treatment (same day as treatment starts)
EuroQoL (EQ-5D)
Time frame: post treatment (same day as treatment ends), ten weeks after treatment start.
EuroQoL (EQ-5D)
Time frame: follow-up (six months after the treatment ended)
Short Form Health Survey (SF-12)
Time frame: pre treatment (same day as treatment starts)
Short Form Health Survey (SF-12)
Time frame: post treatment (same day as treatment ends), ten weeks after treatment start.
Change from baseline health status measured with Short Form Health Survey (SF-12)
Time frame: weekly during treatment (ten times in total, during the ten week long treatment)
Short Form Health Survey (SF-12)
Time frame: follow-up (six months after the treatment ended)

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 14 Apr 2022.
Background: PubMed 9243433Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med. 1997 Jun;19(2):179-86. doi: 10.1093/oxfordjournals.pubmed.a024606.
Derived from this study: PubMed 39194012Wallen H, Ljotsson B, Lindfors P, Forsell E, Hesser H, Svanborg C. Internet-Delivered Exposure-Based Cognitive Behavior Therapy for Irritable Bowel Syndrome: A Clinical Effectiveness Study. Am J Gastroenterol. 2025 Apr 1;120(4):856-863. doi: 10.14309/ajg.0000000000003059. Epub 2024 Aug 28.
Individual participant dataSharing planned: No. No individual participant data will be shared due to General Data Protection Regulation (GDPR). Researchers that want to share the data must apply for ethical permit from The Authority for Ethical Approvals in Sweden.

Related trials for Irritable Bowel Syndrome

Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
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Not yet recruiting
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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.

Brjánn Ljótsson, Ass. Prof. principal investigator

Karolinska Institutet

Questions about this trial

What is this clinical trial studying?

An observational study of Irritable Bowel Syndrome, run by Karolinska Institutet.

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 5 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS) (time frame: pre treatment (same day as treatment starts),). The study lists 4 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 NCT05328245, which also lists 2 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 14 Apr 2022.