Status:
COMPLETED
The Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
King's College London
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Some carbohydrates, complex sugars, which are found in grains, fruit and vegetables, cannot be digested by humans. When eaten they pass through the small bowel to the large bowel, or colon. Some bacte...
Detailed Description
Oligofructose (OF) is a fructose- based oligosaccharide and defined in the European Union as a dietary fibre. Enzymatically derived from the longer chain inulin in chicory, it is commonly used in proc...
Eligibility Criteria
Inclusion
- Aged 18 or older
- Able to give informed consent
Exclusion
- Self-declared vegetarian, vegan or kosher/ halal diet who cannot eat carmine red dye
- Pregnancy declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
- A positive diagnosis of irritable bowel syndrome based on the Rome III criteria questionnaire
- Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
- Intestinal stoma
- Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- Will not limit alcohol intake to ≤ 35 units/ week and ≤ 8 units per day during trial
- Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
- Antibiotic or prescribed probiotic treatment in the past 8 weeks
- Inability to lie flat or exceed scanner limits of weight \<120kg
- Poor understanding of English language
- Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM
- Participation in any medical trials for the past 3 months
- Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02259465
Start Date
September 1 2014
End Date
December 1 2014
Last Update
March 18 2015
Active Locations (1)
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1
Nottingham Digestive Diseases Centre
Nottingham, United Kingdom, NG7 2UH