RecruitingNot ApplicableNCT06551961

Effect of Chronic Feeding of Inulin And Methylcellulose on Colonic Fermentation

A Randomised Placebo Controlled Trial of Chronic Feeding of INuliN And Methylcellulose On Colonic fermentatioN

Sponsor

University of Nottingham

Enrollment

35 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Irritable Bowel Syndrome

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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.

Exclusion Criteria12

Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by candidate.
History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function.
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 use breath hydrogen analyser, known intolerance to one of the test substances.
Has a body mass index (BMI) value less than 18.5 or greater than 35.
Will not agree to follow dietary and lifestyle restrictions required.
Participants who are taking antibiotics or probiotics as it might alters gut microbiota.
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.
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.
Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.