A Randomised Placebo Controlled Trial of Chronic Feeding of INuliN And Methylcellulose On Colonic fermentatioN
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• • Aged between 18 and 65 years old.
‣ Able to give informed consent.
⁃ Scoring ≤5 (i.e., 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 (5).
⁃ Agrees to consume the meals provided.
⁃ Agrees to not smoke during the breath hydrogen sampling period.
Locations
Other Locations
United Kingdom
Nottingham Digestive Disease Centre
RECRUITING
Nottingham
Nottingham Digestive Diseases Centre
RECRUITING
Nottingham
Contact Information
Primary
Alsion Thorpe, MD
alison.thorpe@nottingham.ac.uk
+44 (0)115 7486731
Backup
Sponsor
BB-sponsor@exmail.nottingham.ac.uk
+44 (0)115 7486731
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 35
Treatments
Active_comparator: methylcellulose
2.5 g of Inulin and 2.5g methylcellulose in 62.5 mL water given thrice daily for 7 days increasing to 5 g of Inulin and 5g methylcellulose in 125 mL water on day 8 continuing until day 14
Placebo_comparator: Placebo
2.5 g of Inulin and 2.5g maltodextrin in 62.5 mL water given thrice daily for 7 days increasing to 5 g of Inulin and 5g maltodextrin in 125 mL water on day 8 continuing until day 14
Related Therapeutic Areas
Sponsors
Leads: University of Nottingham
Collaborators: University of East Anglia