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Crohn DiseaseMIC2NCT03052465

Magnetic Resonance Imaging of Motility in Crohn's 2

A study testing Test soup meal feeding intervention in people with Crohn Disease, run by University of Nottingham at 1 site in United Kingdom.

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

Crohn's disease (CD) is becoming more common. One of the main features of this disease is weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems have a strong negative effect on the patients' quality of life but the causes of these problems are not well understood. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn Disease
What is being tested?
Test soup meal feeding intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited Kingdom
Study dates
16 Nov 2015to 7 Mar 2017
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

  • patients with active Cronh's disease
  • Body Mass Index (BMI): 18-30 Kg/m2

Who cannot join

  • Smokers.
  • A history of bowel resections or any gastric surgery.
  • History of pancreatic insufficiency, thyroid disease or/and diabetes.
  • Protein-pump inhibitor usage or any medication that affects gastric emptying or small bowel transit.
  • Any potential participants scoring very highly on the depression scale questionnaire.
  • Standard MRI exclusion criteria (e.g. pacemaker).
Show all 17Show fewer
  • Malignant disease
  • Stricturing or penetrating disease
  • Smoking history
  • History of bowel resections or any gastric surgery
  • Significant cardiovascular or respiratory disease
  • Current Infection
  • Neurological or cognitive impairment
  • Significant physical disability
  • Significant hepatic disease or renal failure
  • Subjects currently (or in the last three months) participating in another research project
  • pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Nottingham Digestive Diseases Centre

    Nottingham, Nottinghamshire, NG7 2UH

Other trials in United Kingdom

About this study

Official title: Reduced Intestinal Motility in Inflammatory Crohn's Disease

Crohn's disease (CD) is becoming more common. One of the main features of this disease is weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems have a strong negative effect on the patients' quality of life but the causes of these problems are not well understood. Enteroendocrine cells are nutrient sensors in the bowel that secrete special chemicals (called hormones) that control appetite and the movements all the gut. The investigators think that this control mechanism goes wrong in Crohn's patients and they have set off to do more research on this. Looking at the inside work of the gut has always been difficult and at times unpleasant for patients, however recent developments in magnetic resonance imaging (MRI) are allowing the investigators to study the workings of the gut in greater detail and without discomfort for the patients.

Our main objective is to investigate the difference in small bowel motility between CD patients with active ileal disease and healthy volunteers.

Read the detailed description

Background: Poor nutrition in Crohn's disease (CD) is common but poorly understood. Apart from disease burden and repeated surgery, reduction in appetite might be an aetiological factor.

Enteroendocrine cells (EC) are intraluminal nutrient sensors. They play a pivotal role in orchestrating physiological functions in the gastrointestinal tract. Sensing the nutrient content of the lumen, they secrete multiple peptides and amines that control gut secretory and motor functions. CD patients with small bowel inflammation show increased expression in EC peptides with exaggerated postprandial responses in anorectic EC hormones. This is associated with symptoms of nausea and anorexia, with EC-peptide expression decreasing to normality in remission.

There has been a longstanding interest on the effect of CD on gastric emptying and gastrointestinal motility. Recent technological advances have allowed us to use magnetic resonance imaging (MRI) to measure both disease activity and intestinal motility.

Reduced intestinal motility has been recently shown in CD patients with active terminal ileal disease. A significant negative correlation is observed between terminal ileal motility and histological, biochemical and radiological measures of disease activity. Intestinal hypomotility may be observed in proximal unaffected segments of small bowel as well.

An increase in EC activity could potentially lead to altered appetite and symptoms of nausea through delayed gastric emptying and most importantly delayed small bowel transit. This mechanistic link has not been described and present findings have not been correlated to patient symptoms. This work can potentially open a new therapeutic pathway in CD therapy. Optimisation studies in healthy volunteers (HV) are urgently needed.

Aims \& Hypothesis: In intestinal inflammation due to CD, the observed up-regulation of fasting and postprandial EC peptides may correlate with a delayed whole gut transit specifically small bowel transit and gastric emptying.

Experimental protocol and methods: 15 Crohn's patients and 20 Healthy volunteers will be recruited. Standard MRI exclusion criteria will apply.

This study will have an open-label design. The subjects will be asked to fast from 2000 h. They will be asked to fill in a questionnaire to ensure adherence to the study day restrictions.

On the day of the scan, they will only be allowed a small glass of water on waking. They will undergo a baseline fasting scan at 0900 hours (defined at t = -45 min time point), together with a fasting baseline blood sample. At 0925 hours, they will be asked to eat their test meal within a maximum time of 20 min so that at 0945 hours the subjects will undergo a first immediate postprandial scan (defined as t = 0 min). This will be followed with data collection (MRI, questionnaire data and blood samples) time points every 15 min for the first 60 min and every 30 min up to 270 min.

At each time point, the positioning of the subject, setup and data collection will take ~15min. After the first 60 min, at completion of data collection at each time-point, the volunteers will be kept sitting upright in a quiet lounge next to the scanner. At each time point, volunteers will fill a 100mm Visual Analogue Scale (VAS) symptoms questionnaire scoring their feeling of fullness, bloating, distension, abdominal pain/discomfort and nausea. The VAS anchors were from 'not' to 'extremely'. Participants will be given a meal at the end of the study.

Participants will be then given a volume (750mls-1000mls) of contrast agent to drink (within 45 minutes) and a further MRI scan (time=30 minutes) will be undertaken to quantify disease activity. Participants will be given a meal at the end of the study. This is not part of the research protocol.

MRI scanning will be carried out supine on either a 1.5T or 3.0 T Philips Achieva MRI scanner (Philips Healthcare, Best, The Netherlands) depending on availability. Fasting and post-prandial plasma tests: On the morning of the test, a 10 ml fasting blood sample will be drawn in aprotonin/EDTA tubes (BD-361017, BD Diagnostics, Oxford). Samples will be measured every 15 min to 270 min. Samples will be centrifuged at 4000 rpm for 5 min and stored on ice. Measurement of plasma peptides: All EC peptides (GLP-1, PYY) will be analysed through ELISA techniques (Millipore, UK). Serum CCK will be measured by RIA (Euro Diagnostic Products, Sweden). Total EC plasma peptide response will be presented as per individual time points and compositely as area under the curve (AUC).

Conditions
Crohn Disease
Being tested
Test soup meal feeding intervention
Keywords
Motility
Medical subject headings
Crohn Disease

What participants receive

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

  • Test soup meal feeding interventionOther

    Cream of chicken soup (400g) (or mushroom for vegetarians) (Heinz, Wigan, UK) used as a test meal intervention. The nutrient content /100g is: energy (kcal) 51, protein (g) 1.5, carbohydrate (g) 4.7, fat (g) 2.93

Study groups in NCT03052465
Study groupRoleWhat they receive
FeedingExperimentalTest soup meal feeding intervention
Receives: Other: Test soup meal feeding intervention

What is being measured

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

  1. Primary Outcome Measure: MRI small bowel motility index (arbitrary units)

    MRI small bowel motility index (arbitrary units)

    Measured: From fasting baseline to 270 min postprandially

Secondary outcomes (8)
  1. Gall bladder contraction

    Gall bladder contraction from MRI images

    Measured: From fasting baseline to 60 min postprandially

  2. Gastric volumes

    Gastric emptying from gastric volumes time courses

    Measured: From fasting baseline to 150 min postprandially

  3. Small bowel water content

    Small bowel water content from MRI images

    Measured: From fasting baseline to 270 min postprandially

  4. Plasma GLP-1

    Postprandial GLP-1 peptide response

    Measured: From fasting baseline to 270 min postprandially

  5. Plasma PYY

    Postprandial PYY peptide response

    Measured: From fasting baseline to 270 min postprandially

  6. Plasma CCK

    Postprandial CCKpeptide response

    Measured: From fasting baseline to 270 min postprandially

  7. Satiety: satiety VAS scores

    Satiety VAS scores

    Measured: From fasting baseline to 270 min postprandially

  8. MaRIA score

    Magnetic resonance index of activity

    Measured: 360 min postprandially

Timeline

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

  1. First posted14 Feb 2017
  2. Study start16 Nov 2015
  3. Primary completion7 Mar 2017
  4. Study completion7 Mar 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052465
Sponsor's protocol ID
15/EM/0003
Acronym
MIC2
Status last verified
Feb 2017
First submitted
9 Feb 2017
Last updated
25 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khalaf A, Hoad CL, Menys A, Nowak A, Radford S, Taylor SA, Latief K, Lingaya M, Falcone Y, Singh G, Spiller RC, Gowland PA, Marciani L, Moran GW. Gastrointestinal peptides and small-bowel hypomotility are possible causes for fasting and postprandial symptoms in active Crohn's disease. Am J Clin Nutr. 2020 Jan 1;111(1):131-140. doi: 10.1093/ajcn/nqz240.

    PubMed 31557279

Questions about this trial

What is this clinical trial studying?

A study testing Test soup meal feeding intervention in people with Crohn Disease, run by University of Nottingham at 1 site 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 2 inclusion and 17 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 25 Oct 2017. 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 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?

Primary Outcome Measure: MRI small bowel motility index (arbitrary units) (time frame: From fasting baseline to 270 min postprandially). 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 NCT03052465, 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 25 Oct 2017.

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