Irritable Bowel SyndromeMANTRANCT03078634

The Multi-disciplinary Treatment of Functional Gut Disorders Study

A study testing Multi-disciplinary clinic model and Standard outpatient care in people with Irritable Bowel Syndrome and Functional Dyspepsia, run by St Vincent's Hospital Melbourne at 1 site in Australia.

Completed

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

Official record

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Trial summary

Randomised controlled trial comparing standard outpatient clinic treatment with multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will be followed up to end of clinic treatment and 12 months beyond the end of treatment. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Irritable Bowel Syndrome, Functional Dyspepsia, Constipation - Functional
What is being tested?: Multi-disciplinary clinic model and Standard outpatient care
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 188 participants
Where: 1 siteAustralia
Study dates: 16 Mar 2017to 28 Apr 2020
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Functional gastrointestinal disorder as defined by Rome IV

Who cannot join

Diagnosed or suspicion of organic gastrointestinal disorder (ie Coeliac, IBD)
Age <18 or >80
Non-English speaking
Patient's from outside of metropolitan Melbourne who cannot attend clinic visits
Prominent eating disorder
Chronic opioid dependence

Show all 11Show fewer

Medications which can explain functional gut symptoms
Surgery of GI tract that can explain functional gut symptoms
Major, non-GI, organ dysfunction
Pregnancy
Major Psychiatric disorder

Trial locations and contacts

1 site in 1 country.

Australia1 site

St Vincent's Hospital
Melbourne, Victoria, 3065

Other trials in Australia

About this study

Official title: The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study

Conditions: Irritable Bowel Syndrome, Functional Dyspepsia, Constipation - Functional, Faecal Incontinence, Functional Abdominal Pain Syndrome, Other Rome IV Functional Gastrointestinal Disorders
Being tested: Multi-disciplinary clinic model, Standard outpatient care
Keywords: Irritable bowel syndrome, Constipation, Functional dyspepsia, Multi-disciplinary treatment
Medical subject headings: Irritable Bowel Syndrome, Encopresis, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multi-disciplinary clinic modelOther
Clinic model incorporating multiple disciplines for the treatment of functional gut disorders. Disciplines include: gastroenterologists, psychiatrists, psychologists, hypnotherapists, behavioural therapists and dieticians. End of clinic case conference involving clinical disciplines will also occur to coordinate care.
Standard outpatient careOther
Standard care provided in outpatient clinics staffed by GI doctors only

Study groups in NCT03078634
Study group	Role	What they receive
Multi-Disciplinary clinic	Active comparator	Not described Receives: Other: Multi-disciplinary clinic model
Standard Gastrointestinal clinic	Placebo comparator	Not described Receives: Other: Standard outpatient care

What is being measured

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

Proportion of subjects with global improvement in their condition.
Global improvement in their condition is defined as a response of either "slightly better" or "much better" to the question: "Compared with before I was first seen in clinic, I feel my gut condition is now:". The question is marked on a 5-point likert scale: Much worse, slightly worse, same, slightly better, much better.
Measured: Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.

Secondary outcomes (12)

Proportion of subjects, with Irritable bowel syndrome or centrally mediated abdominal pain syndrome, with a 50% reduction in Irritable bowel syndrome severity scoring system (IBS-SSS)
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Quality of life as measured by RAND SF-36 v1
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Quality of life as measured by Euro-QOL EQ-5D
Scores from the EQ-5D will be compared between groups and QALY will be derived from EQ-5D.
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Psychological wellbeing as measured by hospital anxiety and depression score (HADS)
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge.
Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO]
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Somatisation as measured by somatic symptom scale-8 (SSS-8)
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Cost to the healthcare system
$AUD per patient cost to the Australian healthcare system.
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with global improvement in their condition.
Global improvement in their condition is defined as a response of either "slightly better" or "much better" to the question: "Compared with before I was first seen in clinic, I feel my gut condition is now:". The question is marked on a 5-point likert scale: Much worse, slightly worse, same, slightly better, much better.
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score
Patients will complete a GISSI (Gastrointestinal symptom severity index) questionnaire at time of "discharge from clinic" and 12 months after "discharge from clinic". The score used will be specific to their symptom cluster.
Measured: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.

Timeline

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

16 Mar 201728 Apr 2020

First posted13 Mar 2017
Study start16 Mar 2017
Primary completion28 Feb 2019
Study completion28 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03078634
Sponsor's protocol ID: MANTRA
Acronym: MANTRA
Status last verified: Nov 2023
First submitted: 24 Feb 2017
Last updated: 29 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Basnayake C, Kamm MA, Stanley A, Wilson-O'Brien A, Burrell K, Lees-Trinca I, Khera A, Kantidakis J, Wong O, Fox K, Talley NJ, Liew D, Salzberg MR, Thompson AJ. Long-Term Outcome of Multidisciplinary Versus Standard Gastroenterologist Care for Functional Gastrointestinal Disorders: A Randomized Trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2102-2111.e9. doi: 10.1016/j.cgh.2021.12.005. Epub 2021 Dec 9.
PubMed 34896645
Basnayake C, Kamm MA, Stanley A, Wilson-O'Brien A, Burrell K, Lees-Trinca I, Khera A, Kantidakis J, Wong O, Fox K, Talley NJ, Liew D, Salzberg MR, Thompson AJ. Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):890-899. doi: 10.1016/S2468-1253(20)30215-6. Epub 2020 Jul 14.
PubMed 32679040
Basnayake C, Kamm MA, Salzberg M, Khera A, Liew D, Burrell K, Wilson-O'Brien A, Stanley A, Talley NJ, Thompson AJ. Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol. Contemp Clin Trials. 2019 Sep;84:105828. doi: 10.1016/j.cct.2019.105828. Epub 2019 Aug 19.
PubMed 31437539

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?

See locations

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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
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Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
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All Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study
ClinicalTrials.gov ID: NCT03078634
Acronym / sponsor ID: MANTRA / MANTRA
Conditions: Irritable Bowel Syndrome, Functional Dyspepsia, Constipation - Functional, Faecal Incontinence, Functional Abdominal Pain Syndrome, Other Rome IV Functional Gastrointestinal Disorders
Keywords: Irritable bowel syndrome, Constipation, Functional dyspepsia, Multi-disciplinary treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: St Vincent's Hospital MelbourneUniversity, hospital or other
Study start: 16 Mar 2017 (actual)
Primary completion: 28 Feb 2019 (actual)
Study completion: 28 Apr 2020 (actual)
First posted: 13 Mar 2017 (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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Multi-Disciplinary clinic	Active comparator	Other: Multi-disciplinary clinic model
Standard Gastrointestinal clinic	Placebo comparator	Other: Standard outpatient care

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Functional gastrointestinal disorder as defined by Rome IV

Key exclusion criteria (11 listed)

Diagnosed or suspicion of organic gastrointestinal disorder (ie Coeliac, IBD)
Age <18 or >80
Non-English speaking
Patient's from outside of metropolitan Melbourne who cannot attend clinic visits
Prominent eating disorder

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
Multi-disciplinary clinic modelClinic model incorporating multiple disciplines for the treatment of functional gut disorders. Disciplines include: gastroenterologists, psychiatrists, psychologists, hypnotherapists, behavioural therapists and dieticians. End of clinic case conference involving clinical disciplines will also occur to coordinate care.	Other	Multi-Disciplinary clinic
Standard outpatient careStandard care provided in outpatient clinics staffed by GI doctors only	Other	Standard Gastrointestinal clinic

Primary outcome

Proportion of subjects with global improvement in their condition.
Time frame: Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.
Global improvement in their condition is defined as a response of either "slightly better" or "much better" to the question: "Compared with before I was first seen in clinic, I feel my gut condition is now:". The question is marked on a 5-point likert scale: Much worse, slightly worse, same, slightly better, much better.

12 secondary outcomes

Proportion of subjects, with Irritable bowel syndrome or centrally mediated abdominal pain syndrome, with a 50% reduction in Irritable bowel syndrome severity scoring system (IBS-SSS)
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Quality of life as measured by RAND SF-36 v1
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Quality of life as measured by Euro-QOL EQ-5D
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Psychological wellbeing as measured by hospital anxiety and depression score (HADS)
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge.
Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO]
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Somatisation as measured by somatic symptom scale-8 (SSS-8)
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Cost to the healthcare system
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with global improvement in their condition.
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score
Time frame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.

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 29 Nov 2023.
Derived from this study: PubMed 34896645Basnayake C, Kamm MA, Stanley A, Wilson-O'Brien A, Burrell K, Lees-Trinca I, Khera A, Kantidakis J, Wong O, Fox K, Talley NJ, Liew D, Salzberg MR, Thompson AJ. Long-Term Outcome of Multidisciplinary Versus Standard Gastroenterologist Care for Functional Gastrointestinal Disorders: A Randomized Trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2102-2111.e9. doi: 10.1016/j.cgh.2021.12.005. Epub 2021 Dec 9.
Derived from this study: PubMed 32679040Basnayake C, Kamm MA, Stanley A, Wilson-O'Brien A, Burrell K, Lees-Trinca I, Khera A, Kantidakis J, Wong O, Fox K, Talley NJ, Liew D, Salzberg MR, Thompson AJ. Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):890-899. doi: 10.1016/S2468-1253(20)30215-6. Epub 2020 Jul 14.
Derived from this study: PubMed 31437539Basnayake C, Kamm MA, Salzberg M, Khera A, Liew D, Burrell K, Wilson-O'Brien A, Stanley A, Talley NJ, Thompson AJ. Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol. Contemp Clin Trials. 2019 Sep;84:105828. doi: 10.1016/j.cct.2019.105828. Epub 2019 Aug 19.
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.

Chamara Basnayake, MBBS principal investigator

Gastroenterologist / PhD candidate

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 11 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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?

Proportion of subjects with global improvement in their condition. (time frame: Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.). 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 NCT03078634, which also lists 3 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 29 Nov 2023.