Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06551961

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

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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