Crohn's DiseaseNCT02772458
Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake
A study testing Dodecanoate acid and saline in people with Crohn's Disease, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
Crohn's disease (CD) is becoming more common, specifically in the western world. One of the main features of this disease is weight loss and malnutrition. Although clinically common, these problems are not well understood. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Dodecanoate acid and saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2015to Sep 2018
- 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 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 16-75 years
- Ulceration seen at ileocolonoscopy, aiming for a simple endoscopic score for Crohn's disease (SES-CD) of 4-19, in the absence of stricturing disease or,
- Intestinal inflammation or deep ulceration seen on CT or MR enterography, with the disease activity quantified via the MaRIA score or,
- Faecal calprotectin of >250µg/g
- C-Reactive protein >5mg/dl
- Harvey-Bradshaw index score of 5-16
- Body mass index (BMI) 18-35
- As for HV participants, inclusion criteria 1 and 7 will apply.
Who cannot join
- Malignant disease
- BMI <18 and >35
- Significant cardiovascular or respiratory disease
- Diabetes mellitus
- Current Infection
- Neurological or cognitive impairment; significant physical disability
Show all 13Show fewer
- Significant hepatic disease or renal failure
- Abnormal blood results other than those explained by CD including bleeding diatheses (apart from in the case of HV where all unexplained blood results are an exclusion criteria)
- Subjects currently participating in (or in the last three months) any other research project
- pregnancy or breastfeeding or
- if MRI is contraindicated (e.g. pacemaker).
- Severe Crohn's disease where a delay in a change in medical treatment for 23 weeks would not be clinically advisable.
- As for healthy volunteer participants all exclusion criteria apart from no.12.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Nottingham
Nottingham, NG7 2RD
University of Nottingham
Nottingham
About this study
Official title: Reduced Appetite in Crohn's Disease: Investigating the Role of the Gut Brain Pathways
Crohn's disease (CD) is becoming more common, specifically in the western world. One of the main features of this disease is weight loss and malnutrition. Although clinically common, these problems are not well understood. Loss of appetite and symptoms such as tummy aches and bloating are common causes for weight loss in this group of patients. This problem has a strong negative effect on the patients' quality of life and significantly increases the cost of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the brain to control food intake. Recent evidence has showed that these cells increase in number in active CD and secrete more hormones that negatively affect appetite. The increased levels of these hormones should have an overall negative effect on the brain and thus decrease food intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are hypotheses that require further proof. Current technological advances in magnetic resonance imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain that control food intake. The involvement of the brain in control of food intake is still not fully understood. This work will be the first step in the right direction to start targeting the problems of appetite, weight loss and a poor quality of life.
- Conditions
- Crohn's Disease
- Being tested
- Dodecanoate acid and saline
- Keywords
- Crohn's Disease, gut brain axis, reduced appetite
- Medical subject headings
- Crohn Disease, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dodecanoate acid and salineOther
Test drink
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease | Experimental | Active Crohn's Disease Receives: Other: Dodecanoate acid and saline |
| Healthy | Experimental | Healthy volunteers Receives: Other: Dodecanoate acid and saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Blood Oxygenation Level Dependent (BOLD) response in the brain following a fatty acid test meal in Crohn's patients and healthy controls
Measured: 3 years
Secondary outcomes (1)
Changes in arterial spin labeling measures of cerebral blood flow and changes in gut peptide levels following the fatty acid test meal.
The increase or decrease in BOLD signal of the brain following the fatty acid stimuli will be correlated to the gut peptide levels which are listed as follows:
- CCK (pmol/ml)
- GLP-1 (pM)
- PYY (pg/ml)
- Ghrelin (ng/ml)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772458
- Sponsor's protocol ID
- 14038
- Status last verified
- Oct 2017
- First submitted
- 11 Feb 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Appetite in Crohn's Disease: Investigating the Role of the Gut Brain Pathways
- ClinicalTrials.gov ID
- NCT02772458
- Acronym / sponsor ID
- 14038
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, gut brain axis, reduced appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 13 May 2016 (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.
Crohn's disease (CD) is becoming more common, specifically in the western world. One of the main features of this disease is weight loss and malnutrition. Although clinically common, these problems are not well understood. Loss of appetite and symptoms such as tummy aches and bloating are common causes for weight loss in this group of patients. This problem has a strong negative effect on the patients' quality of life and significantly increases the cost of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the brain to control food intake. Recent evidence has showed that these cells increase in number in active CD and secrete more hormones that negatively affect appetite. The increased levels of these hormones should have an overall negative effect on the brain and thus decrease food intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are hypotheses that require further proof. Current technological advances in magnetic resonance imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain that control food intake. The involvement of the brain in control of food intake is still not fully understood. This work will be the first step in the right direction to start targeting the problems of appetite, weight loss and a poor quality of life.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease | Experimental | Other: Dodecanoate acid and salineActive Crohn's Disease |
| Healthy | Experimental | Other: Dodecanoate acid and salineHealthy volunteers |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 16-75 years
- Ulceration seen at ileocolonoscopy, aiming for a simple endoscopic score for Crohn's disease (SES-CD) of 4-19, in the absence of stricturing disease or,
- Intestinal inflammation or deep ulceration seen on CT or MR enterography, with the disease activity quantified via the MaRIA score or,
- Faecal calprotectin of >250µg/g
- C-Reactive protein >5mg/dl
Key exclusion criteria (13 listed)
- Malignant disease
- BMI <18 and >35
- Significant cardiovascular or respiratory disease
- Diabetes mellitus
- Current Infection
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 |
|---|---|---|
| Dodecanoate acid and salineTest drink | Other | Crohn's Disease, Healthy |
Primary outcome
Changes in Blood Oxygenation Level Dependent (BOLD) response in the brain following a fatty acid test meal in Crohn's patients and healthy controls
Time frame: 3 years
1 secondary outcome
Changes in arterial spin labeling measures of cerebral blood flow and changes in gut peptide levels following the fatty acid test meal.
Time frame: 3 years
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 17 Apr 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dodecanoate acid and saline in people with Crohn's Disease, run by University of Nottingham at 2 sites in United Kingdom.
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 8 inclusion and 13 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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Changes in Blood Oxygenation Level Dependent (BOLD) response in the brain following a fatty acid test meal in Crohn's patients and healthy controls (time frame: 3 years). 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 17 Apr 2019.