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Effect of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI

Randomised Placebo Controlled Trial of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI (RUFUS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06291272
Acronym
RUFUS
Enrollment
22
Registered
2024-03-04
Start date
2023-10-15
Completion date
2024-06-30
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon, Irritable

Brief summary

The challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of fermentable oligo-di- and mono-saccharides and polyhydric alcohols (FODMAPs). Studies will exploit the recent availability of a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances (4). The investigators are currently performing the COCOA2 study (Effect of modified cellulose on colonic fermentation of inulin) using a modified methylcellulose (results awaited). The investigators now wish to image what happens in the colon when methylcellulose is ingested to enable planning of the next step in the research programme.

Detailed description

Aim The aim is to test the hypothesis that a gel of either methylcellulose or psyllium incorporating inulin will reduce colonic gas volumes assessed by MRI 0-6 hours and 24 hours post ingestion as compared to inulin combined with placebo, maltodextrin. Objective The primary objective is to define the effect of methylcellulose and /or psyllium on colonic gas as assessed by MRI. Previous studies have used large doses to ensure a large effect to avoid a type II error however the doses used are well outside the normal consumption. The investigators wish to compare the effect of the methylcellulose mix on the fermentation of 15 g of inulin. Secondary Objectives A) Assess the effect of methylcellulose on gastric emptying, oro-cecal transit time (OCTT) by MRI assessment of arrival of head of meal, regional MRI colonic appearances, including signal intensity at 6 and 24 hours to determine the likely length of effect, C) to asses breath hydrogen production over 24 hour post ingestion including overnight assessments, D) to assess Whole Gut Transit Time (WGTT) using blue muffins test, E) to measure AUC (0-24) for breath methane; F) to measure gas production over 48 hours incubation in vitro model of colon (in collaboration with Quadram Institute); G) to measure metabolite production (short chain fatty acids) using in vitro model of colon(in collaboration with Quadram Institute); H) to analyse microbiota using 16sRNA gene (in collaboration with Quadram Institute); I) to assess the effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin.

Interventions

DIETARY_SUPPLEMENTPsyllium

15 g psyllium + 15 g inulin

DIETARY_SUPPLEMENTMethylcellulose

15 g methylcellulose + 15 g inulin

DIETARY_SUPPLEMENTInulin

15 inulin

DIETARY_SUPPLEMENTMaltodextrin

15 maltodextrin

Sponsors

Quadram Institute Bioscience
CollaboratorOTHER
University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Opaque plastic bags containing test meals prepared by some one not involved in analysis pf results

Intervention model description

3 way cross -over

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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 criteria

* • 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. * Have contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury. * Unable to lie flat and relatively still for less than 5 minutes. * 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. * 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, low dose tricyclic antidepressants, antihistamines, and oral contraceptive pill will be recorded in the CRF but will not be an

Design outcomes

Primary

MeasureTime frameDescription
colonic gas volume0-6 hoursAUC 0-6 hours of colonic gas volume

Secondary

MeasureTime frameDescription
colonic gas volume at 6 hours0-6 hoursMRI assessed colonic gas volume at 6 hours
Breath hydrogen0-6 hoursArea under curve (AUC) from time 0-6 hours of breath hydrogen (ppm.hours)
Oro-cecal transit time0- 6 hours
24 hour breath hydrogen0-24 hoursArea under curve (AUC) from time 0-24 hours of breath hydrogen (ppm.hours)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026