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HealthyPhase 4NCT01763281

Imaging the Effect of Experimental Stress on Small and Large Bowel Water During Fructose Absorption

A Phase 4 study testing CRH in people with Healthy, run by University of Nottingham at 2 sites 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

The investigators have been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the small bowel. Building on those studies the investigators want to study, in healthy volunteers, the effects of stress on the water content of the small bowel following ingestion of fructose. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
CRH
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
2 sitesUnited Kingdom
Study dates
Oct 2012to Feb 2013
Phase
Phase 4
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female healthy volunteers who are 18-60 years old
  • Age ≥ 18 and ≤ 60 year at pre-study investigation.
  • Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2
  • Able to give voluntary informed consent to participate in the study
  • Able to understand the requirements of the study including anonymous publication and free to cooperate with the study procedures

Who cannot join

  • Lactose intolerance
  • Any history of serious acute or chronic illness especially gastrointestinal
  • Any history of Raynaud's syndrome or impairment of circulation
  • Any history of heart or lung disease
  • Pregnancy or breastfeeding
  • Smoking
Show all 12Show fewer
  • Unsuitable for MRI scanning (i.e. have metal implants or pacemaker)
  • Regular medication interfering with gastrointestinal function, opiates or constipating drugs
  • Substance abuse
  • Have taken part in any other clinical study within the previous 3 months
  • Previous gastrointestinal surgery
  • Use of medication which interferes with study measurements or bowel motility (as judged by the study physician) such as antibiotics in the 2 weeks before pre-study examination or probiotics.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham

    Nottingham, NG72RD

  • NIHR Nottingham Digestive Diseases Biomedical Research Unit

    Nottingham, NG72UH

Other trials in United Kingdom

About this study

The investigators have been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the small bowel. Building on those studies the investigators want to study, in healthy volunteers, the effects of stress on the water content of the small bowel following ingestion of fructose. This is important because in Irritable Bowel Syndrome (IBS), there seems to be a strong association of stress and anxiety with the severity of the disease. Many IBS patients complain of food intolerances and recent studies have suggested that food with high content of fructose can worsen symptoms of IBS. The investigators will carry out a study in which the investigators will induce a moderate state of stress in healthy volunteers using an injection of corticotrophin release hormone, feed them a drink containing fructose and image their bowel at intervals using MRI. Improving our understanding of the effects of stress and fructose on small bowel physiology will help us to understand better some aspects of the symptoms such as bloating, altered bowel habit and abdominal discomfort, experienced by the IBS patients and to guide therapy. The investigators hypothesize that the effect of CRH will cause significant decrease in small bowel water content (SBWC) and a faster small bowel transit with increased malabsorption following consumption of fructose.

Read the detailed description

A single centre, randomized cross over study consisting a screening visit and 2 test days which will be approximately 7 days apart. The participants will receive 1g unlabelled lactose ureide in a glass of water 3 times a day on the day before the study day to induce the enzyme activity in the colonic bacteria. The participants (20 healthy volunteers) will have a baseline scan in a 1.5T MRI scanner before having a small intravenous needle inserted into their forearm. Following this procedure, the participant will have another scan before being given either a saline (0.9% NaCl) or 100microgram of CRH intravenous injection. 40g of fructose and 500mg of labeled C-13 lactose ureide dissolved in water with pure lime juice as flavorant made up to 500mL will be given to the participants. They will then have a serial scanning of the abdomen at 30-60 minutes interval for 5 hours post prandially. Salivary cortisol will be collected after every MRI scans. Participants will also be asked to blow into the hydrogen breath machine and to fill in symptom questionnaire following each MRI scans. Further breath collections for orocaecal transit time will be collected initially every 10 minutes for the first hour and 15 mins until the end of the study day. Mouthwash will be used before initial breath test collection. This procedure will be repeated again on the 2nd test day with either a saline or 100microgram of CRH.

Conditions
Healthy
Being tested
CRH, Placebo

What participants receive

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

  • CRHDrug

    Also called Generic name: Corticorelin trifluroacetate, Proprietary name: CRH Ferring

  • PlaceboDrug

    Also called Normal Saline (0.9%)

Study groups in NCT01763281
Study groupRoleWhat they receive
CRHActive comparator100 microgram bolus of Cortisol Releasing Hormone intravenous injection given at a 20 minutes prior to Fructose drink during one of the two visits. The placebo comparator will be 0.9% saline (1ml) bolus injection given intravenously at the same time point during one of the two visits
Receives: Drug: CRH
Normal Saline (0.9%)Placebo comparator100 microgram bolus of Cortisol Releasing Hormone intravenous injection given at a 20 minutes prior to Fructose drink during one of the two visits. The placebo comparator will be 0.9% saline (1ml) bolus injection given intravenously at the same time point during one of the two visits
Receives: Drug: Placebo

What is being measured

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

  1. Effect of CRF on area under curve volume versus time curve for small bowel water

    Magnetic Resonance Imaging will be used to measure small bowel water at 30-60 minutes intervals for a total of 430 minutes

    Measured: 430 minutes in total

  2. Effect of CRF on increase in volume of gas in colon at 255 minutes

    Magnetic resonance imaging will be used to assess colonic gas at 255 minute time point

    Measured: 15 minutes

Secondary outcomes (6)

  1. Gastric Emptying

    Magnetic Resonance Imaging will be used to assess gastric emptying at 30-60 minute intervals for a total of 430 minutes

    Measured: 430 minutes

  2. small bowel transit time using lactose C-13 ureide

    Unlabelled lactose ureide 1g x3/day will be given 24 hours prior to study day. They will then be given 500mg 13C labelled lactose ureide on the study day and breath collections every 10 minutes initially for 1 hour and every 15 minute for subsequent hours

    Measured: 430 minutes

  3. Ascending colon volume

    Ascending colon volumes will be assessed using the Magnetic Resonance Imaging technique at 30-60 minute intervals

    Measured: 430 minutes

  4. Volume of gas in colon

    Volume of gas in colon will be assessed using the Magnetic Resonance Imaging technique at 30-60 minute intervals

    Measured: 430 minutes

  5. salivary cortisol level versus small bowel water content

    Saliva samples will be collected at the 30-60 minute intervals (as per the magnetic resonance imaging scans for small bowel water content)

    Measured: 430 minutes

  6. Correlating symptom scores on the study day and Bristol Stool diary

    Stool diary to be collected for a week

    Measured: 7 days

Timeline

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

  1. First posted8 Jan 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionJan 2013
  4. Study completionFeb 2013

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 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01763281
Sponsor's protocol ID
E12072012SCS
Status last verified
Feb 2013
First submitted
4 Jan 2013
Last updated
6 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • Murray KA, Lam C, Rehman S, Marciani L, Costigan C, Hoad CL, Lingaya MR, Banwait R, Bawden SJ, Gowland PA, Spiller RC. Corticotropin-releasing factor increases ascending colon volume after a fructose test meal in healthy humans: a randomized controlled trial. Am J Clin Nutr. 2016 May;103(5):1318-26. doi: 10.3945/ajcn.115.125047. Epub 2016 Apr 20.

    PubMed 27099247

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CRH in people with Healthy, 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 5 inclusion and 12 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 6 Feb 2013. 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. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Effect of CRF on area under curve volume versus time curve for small bowel water (time frame: 430 minutes in total). The study lists 2 primary outcomes in all. 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 NCT01763281, 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 6 Feb 2013.

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