Actively Recruiting
Effect of Chronic Feeding of Inulin And Methylcellulose on Colonic Fermentation
Led by University of Nottingham · Updated on 2024-11-15
35
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
University of Nottingham
Lead Sponsor
U
University of East Anglia
Collaborating Sponsor
AI-Summary
What this Trial Is About
To determine the effect on tolerance and gas production from chronic feeding of fermentable fibre (inulin) incorporated into a gel forming fibre (methylcellulose) compared with placebo (maltodextrin)
CONDITIONS
Official Title
Effect of Chronic Feeding of Inulin And Methylcellulose on Colonic Fermentation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 65 years old.
- Able to give informed consent.
- Scoring 645 (mild or less) for symptoms of flatulence, bloating, abdominal pain, loose stool, and hard stool in previous 2 weeks using a modified Gastrointestinal Symptom Rating Scale.
- Agrees to consume the meals provided.
- Agrees to not smoke during the breath hydrogen sampling period.
You will not qualify if you...
- Pregnancy, lactating, or planning pregnancy during the study.
- History of gastrointestinal disorders affecting bowel function.
- Previous resection of esophagus, stomach, or intestines (excluding appendix).
- Intestinal stoma.
- Medical conditions that may compromise participation (e.g., diabetes, respiratory disease limiting breath hydrogen test use, intolerance to test substances).
- Body mass index less than 18.5 or greater than 35.
- Unwilling to follow dietary and lifestyle restrictions.
- Unable to stop drugs known to alter GI motility (except certain antidepressants, antihistamines, oral contraceptives).
- Taking antibiotics or probiotics.
- Poor understanding of English.
- Participation in night shift work the week before the study.
- Investigator judgment of inability to comply (e.g., cognitive dysfunction, substance abuse).
- Participation in research with invasive procedures or inconvenience allowance in last 3 months.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Nottingham Digestive Disease Centre
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Actively Recruiting
2
Nottingham Digestive Diseases Centre
Nottingham, Please Choose..., United Kingdom, NG7 2UH
Actively Recruiting
Research Team
A
Alsion Thorpe, MD
CONTACT
S
Sponsor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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