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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763281
First Posted: January 8, 2013
Last Update Posted: February 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Nottingham
  Purpose
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.

Condition Intervention Phase
Healthy Drug: CRH Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Imaging the Effect of Experimental Stress on Small and Large Bowel Water During Fructose Absorption

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Effect of CRF on area under curve volume versus time curve for small bowel water [ Time Frame: 430 minutes in total ]
    Magnetic Resonance Imaging will be used to measure small bowel water at 30-60 minutes intervals for a total of 430 minutes

  • Effect of CRF on increase in volume of gas in colon at 255 minutes [ Time Frame: 15 minutes ]
    Magnetic resonance imaging will be used to assess colonic gas at 255 minute time point


Secondary Outcome Measures:
  • Gastric Emptying [ Time Frame: 430 minutes ]
    Magnetic Resonance Imaging will be used to assess gastric emptying at 30-60 minute intervals for a total of 430 minutes

  • small bowel transit time using lactose C-13 ureide [ Time Frame: 430 minutes ]
    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

  • Ascending colon volume [ Time Frame: 430 minutes ]
    Ascending colon volumes will be assessed using the Magnetic Resonance Imaging technique at 30-60 minute intervals

  • Volume of gas in colon [ Time Frame: 430 minutes ]
    Volume of gas in colon will be assessed using the Magnetic Resonance Imaging technique at 30-60 minute intervals

  • salivary cortisol level versus small bowel water content [ Time Frame: 430 minutes ]
    Saliva samples will be collected at the 30-60 minute intervals (as per the magnetic resonance imaging scans for small bowel water content)

  • Correlating symptom scores on the study day and Bristol Stool diary [ Time Frame: 7 days ]
    Stool diary to be collected for a week


Enrollment: 20
Study Start Date: October 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CRH

100 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

Drug: CRH
Other Names:
  • Generic name: Corticorelin trifluroacetate
  • Proprietary name: CRH Ferring
Placebo Comparator: Normal Saline (0.9%)

100 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

Drug: Placebo
Other Name: Normal Saline (0.9%)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763281


Locations
United Kingdom
Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham
Nottingham, United Kingdom, NG72RD
NIHR Nottingham Digestive Diseases Biomedical Research Unit
Nottingham, United Kingdom, NG72UH
Sponsors and Collaborators
University of Nottingham
Investigators
Study Chair: Robin Spiller, MD FRCP University of Nottingham
Principal Investigator: Ching Lam, MBchB MRCP University of Nottingham
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01763281     History of Changes
Other Study ID Numbers: E12072012SCS
First Submitted: January 4, 2013
First Posted: January 8, 2013
Last Update Posted: February 6, 2013
Last Verified: February 2013