Ulcerative ColitisNCT02469220
Diet Treatment of Patients With Ulcerative Colitis in Remission
A study testing Low FODMAP and Standardized FODMAP in people with Ulcerative Colitis, run by Regionshospital Nordjylland at 1 site in Denmark.
Trial summary
The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Low FODMAP and Standardized FODMAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2018to 26 Apr 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colitis ulcerosa in remission (calciprotectin<200 and normal sigmoidoscopy)
- ROM IV criteria fullfilled
- Stable medical therapy
Who cannot join
- Intake of a low FODMAP diet within the past 6 weeks prior to baseline
- Atypical colitis ulcerosa primarily right sided disease and calciprotectin >50 unless normal sigmoidoscopy
- If diarrhea: Clostridium difficile infection
- Lactose intolerance
- Systemisk or local treatment for CU other than 5-aminosalicylicacid or biological therapy
- Antibiotics within 6 weeks
Show all 15Show fewer
- Pregnancy
- Activity in UC
- Coeliac disease
- Abnormal transglutaminase
- Eating disorder
- Special diet preventing the low FODMAP diet
- Other GI disease or other disease explaining symptoms
- Medication intake explaining symptoms
- Not able to follow protocol
Trial locations and contacts
1 site in 1 country.
About this study
The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.
Read the detailed description
Patients are randomized to either standard care, low FODMAP diet or a normal FODMAP diet. Run-in on a low FODMAP diet, thereafter parallel design where one arm is assign a blinded food supplement with low FODMAP content and the other arm is assigned a blinded food supplement containing FODMAP. A control group is "watchful waiting".
Symptom reports, blood, and fecal samples are collected.
- Conditions
- Ulcerative Colitis
- Being tested
- Low FODMAP, Standardized FODMAP
- Keywords
- Diet, low FODMAP, UC, IBS
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAPDietary supplement
Blinded food supplements containing only items with a low content of FODMAPs
Standardized FODMAPDietary supplement
Blinded food supplements containing FODMAPs
| Study group | Role | What they receive |
|---|---|---|
| Low FODMAP diet | Experimental | Diet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement low in FODMAPS are administered in a blinded fashion. Receives: Dietary Supplement: Low FODMAP |
| Standardized FODMAP | Active comparator | Diet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement with FODMAPS are administered in a blinded fashion. Receives: Dietary Supplement: Standardized FODMAP |
| Control | No intervention | Watchful waiting. No diets or food supplements are administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms
IBS-SSS questionnaire
Measured: Week 8
Secondary outcomes (2)
Change in Quality of life
SF-36 questionnaire
Measured: Week 8
Pain diary
VAS scales on a daily basis
Measured: Daily during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study start1 Jul 2018
- Primary completion31 Aug 2020
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anne Lund Krarup, Regionshospital Nordjylland
- Investigators
- Anne L Krarup, PhD, Principal investigator, Regionshospital NordjyllandJeanette Soerensen, PhD-student, Principal investigator, Regionshospital Nordjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469220
- Sponsor's protocol ID
- RHN_ALK_01
- Status last verified
- Apr 2022
- First submitted
- 8 Jun 2015
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Treatment of Patients With Ulcerative Colitis in Remission
- ClinicalTrials.gov ID
- NCT02469220
- Acronym / sponsor ID
- RHN_ALK_01
- Conditions
- Ulcerative Colitis
- Keywords
- Diet, low FODMAP, UC, IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 11 Jun 2015 (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.
The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.
Detailed description
Patients are randomized to either standard care, low FODMAP diet or a normal FODMAP diet. Run-in on a low FODMAP diet, thereafter parallel design where one arm is assign a blinded food supplement with low FODMAP content and the other arm is assigned a blinded food supplement containing FODMAP. A control group is "watchful waiting".
Symptom reports, blood, and fecal samples are collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP diet | Experimental | Dietary Supplement: Low FODMAPDiet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement low in FODMAPS are administered in a blinded fashion. |
| Standardized FODMAP | Active comparator | Dietary Supplement: Standardized FODMAPDiet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement with FODMAPS are administered in a blinded fashion. |
| Control | No intervention | –Watchful waiting. No diets or food supplements are administered |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Colitis ulcerosa in remission (calciprotectin<200 and normal sigmoidoscopy)
- ROM IV criteria fullfilled
- Stable medical therapy
Key exclusion criteria (15 listed)
- Intake of a low FODMAP diet within the past 6 weeks prior to baseline
- Atypical colitis ulcerosa primarily right sided disease and calciprotectin >50 unless normal sigmoidoscopy
- If diarrhea: Clostridium difficile infection
- Lactose intolerance
- Systemisk or local treatment for CU other than 5-aminosalicylicacid or biological therapy
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 |
|---|---|---|
| Low FODMAPBlinded food supplements containing only items with a low content of FODMAPs | Dietary supplement | Low FODMAP diet |
| Standardized FODMAPBlinded food supplements containing FODMAPs | Dietary supplement | Standardized FODMAP |
Primary outcome
Gastrointestinal symptoms
Time frame: Week 8
IBS-SSS questionnaire
2 secondary outcomes
Change in Quality of life
Time frame: Week 8
Pain diary
Time frame: Daily during the study
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 27 Apr 2022.
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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.
Anne L Krarup, PhD principal investigator
Regionshospital Nordjylland
Jeanette Soerensen, PhD-student principal investigator
Regionshospital Nordjylland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low FODMAP and Standardized FODMAP in people with Ulcerative Colitis, run by Regionshospital Nordjylland at 1 site in Denmark.
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 3 inclusion and 15 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 27 Apr 2022. 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 Denmark. 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?
Gastrointestinal symptoms (time frame: Week 8). 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 27 Apr 2022.