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Search / Trial NCT02259465

The Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota

Launched by UNIVERSITY OF NOTTINGHAM · Oct 3, 2014

Trial Information

Current as of May 07, 2025

Completed

Keywords

Microbiota Fodmap Oligofructose Magnetic Resonance Imaging Metabolomics Diet

ClinConnect Summary

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 processed food to improve mouth feel in fat-free products. OF is poorly digested and absorbed in the small bowel so passes to the colon where it is fermented by the bacteria usually resident in the colon, termed the microbiota. This process produces gases such as hydrogen and sometimes methane, and short-chain fatty acids (SCFAs) which have a variety of roles including nutrition to colonocytes, imm...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged 18 or older
  • Able to give informed consent
  • Exclusion Criteria:
  • 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

About University Of Nottingham

The University of Nottingham is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses cutting-edge research and expert faculty to address pressing medical challenges. Through its dedicated clinical trials unit, the University of Nottingham conducts rigorous studies aimed at improving patient outcomes and contributing to the global body of medical knowledge. The institution prioritizes ethical practices and participant safety, ensuring that all trials are designed to uphold the highest standards of scientific integrity and regulatory compliance.

Locations

Nottingham, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Robin C Spiller, MD FRCP

Study Chair

University of Nottingham

Giles AD Major, BMBCh MRCP

Principal Investigator

University of Nottingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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