Irritable Bowel SyndromeNCT01829932
The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study
A study testing Factor Altered Diet in people with Irritable Bowel Syndrome, run by Queen's University at 1 site in Canada.
Trial summary
Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to influence the bacteria gut interaction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Factor Altered Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Dec 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet Rome III criteria for IBS
- Willing to undergo dietary intervention
Who cannot join
- History of Gastric, Small Bowel or Colonic Surgery
- History of Inflammatory Bowel Disease
- Celiac Disease
- Unable to come off following medications: antibiotics, laxatives, narcotics, sedatives
- On a pre specified diet
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to influence the bacteria gut interaction. Our aim is to determine if components of the diet affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure whether after being on a diet high or low on certain factors there is a change in the timing and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS symptom severity.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Factor Altered Diet
- Keywords
- Diet
- 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.
Factor Altered DietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| High Factor Diet | Active comparator | Patients will be on a factor altered diet to see effects on their lactulose breath test and symptoms. Receives: Dietary Supplement: Factor Altered Diet |
| Low Factor Diet | Active comparator | Patients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test. Receives: Dietary Supplement: Factor Altered Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Curve of Hydrogen Gas on Lactulose Breath Test
Measured: 5 hours
Secondary outcomes (2)
Change in Area Under the Curve on Lactulose Breath Test from Baseline
Measured: 5 hours
Change in IBS Symptom Severity Score from Baseline
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionDec 2014
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stephen Vanner, Queen's University
- Investigators
- Stephen Vanner, MD, FRCPC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829932
- Sponsor's protocol ID
- DMED-1443-11
- Status last verified
- Oct 2015
- First submitted
- 9 Apr 2013
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McIntosh K, Reed DE, Schneider T, Dang F, Keshteli AH, De Palma G, Madsen K, Bercik P, Vanner S. FODMAPs alter symptoms and the metabolome of patients with IBS: a randomised controlled trial. Gut. 2017 Jul;66(7):1241-1251. doi: 10.1136/gutjnl-2015-311339. Epub 2016 Mar 14.
PubMed 26976734
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study
- ClinicalTrials.gov ID
- NCT01829932
- Acronym / sponsor ID
- DMED-1443-11
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to influence the bacteria gut interaction. Our aim is to determine if components of the diet affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure whether after being on a diet high or low on certain factors there is a change in the timing and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS symptom severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Factor Diet | Active comparator | Dietary Supplement: Factor Altered DietPatients will be on a factor altered diet to see effects on their lactulose breath test and symptoms. |
| Low Factor Diet | Active comparator | Dietary Supplement: Factor Altered DietPatients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet Rome III criteria for IBS
- Willing to undergo dietary intervention
Key exclusion criteria (6 listed)
- History of Gastric, Small Bowel or Colonic Surgery
- History of Inflammatory Bowel Disease
- Celiac Disease
- Unable to come off following medications: antibiotics, laxatives, narcotics, sedatives
- On a pre specified diet
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 |
|---|---|---|
| Factor Altered Diet | Dietary supplement | High Factor Diet, Low Factor Diet |
Primary outcome
Area under the Curve of Hydrogen Gas on Lactulose Breath Test
Time frame: 5 hours
2 secondary outcomes
Change in Area Under the Curve on Lactulose Breath Test from Baseline
Time frame: 5 hours
Change in IBS Symptom Severity Score from Baseline
Time frame: 3 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 14 Oct 2015.
- Derived from this study: PubMed 26976734McIntosh K, Reed DE, Schneider T, Dang F, Keshteli AH, De Palma G, Madsen K, Bercik P, Vanner S. FODMAPs alter symptoms and the metabolome of patients with IBS: a randomised controlled trial. Gut. 2017 Jul;66(7):1241-1251. doi: 10.1136/gutjnl-2015-311339. Epub 2016 Mar 14.
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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.
Stephen Vanner, MD, FRCPC principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Factor Altered Diet in people with Irritable Bowel Syndrome, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 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: finished, as of the sponsor's last update on 14 Oct 2015. 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the Curve of Hydrogen Gas on Lactulose Breath Test (time frame: 5 hours). 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 NCT01829932, 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 14 Oct 2015.