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

NCT01763281 | Completed Phase 4

• 1 other identifier: E12072012SCS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

  430 minutes in total

• 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

  15 minutes

Secondary Outcomes (6)

• Gastric Emptying

  430 minutes

• small bowel transit time using lactose C-13 ureide

  430 minutes

• Ascending colon volume

  430 minutes

• Volume of gas in colon

  430 minutes

• salivary cortisol level versus small bowel water content

  430 minutes

Study Arms (2)

CRH

ACTIVE COMPARATOR

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

Normal Saline (0.9%)

PLACEBO COMPARATOR

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

Interventions

CRH DRUG

Also known as: Generic name: Corticorelin trifluroacetate, Proprietary name: CRH Ferring

CRH

Placebo DRUG

Also known as: Normal Saline (0.9%)

Normal Saline (0.9%)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (2)

Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham

Nottingham, NG72RD, United Kingdom

Location

NIHR Nottingham Digestive Diseases Biomedical Research Unit

Nottingham, NG72UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27099247 DERIVED

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Robin Spiller, MD FRCP

  University of Nottingham

  STUDY CHAIR

• Ching Lam, MBchB MRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 8, 2013
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

GB (2)