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

Colon, Irritable Clinical Trial

— RUFUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291272
• Other study ID #: FMHS 328-0723
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: University of Nottingham
• Contact: Robin Spiller
• Phone: +447824328319
• Email: robin.spiller[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of FODMAPs. We 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). We are currently performing the COCOA2 study using a modified methylcellulose (results awaited). We now wish to perform a pilot study to image what happens in the colon when methylcellulose is ingested to enable us to plan the next step in our research programme.

Description:

Aim Our aim is to pilot the next study which will 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 of this pilot is to find the minimum dose which will clearly show 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. We wish to compare the effect of our methylcellulose mix on the fermentation of 10 and 15 g of inulin by offering different doses of fibre gel drink.,

Secondary Objectives A) Assess the effect of methylcellulose on gastric emptying, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: October 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exclusion criteria).

• 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.

Related Conditions & MeSH terms

• Colon, Irritable
• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• Psyllium
15 g psyllium + 15 g inulin
• Methylcellulose
15 g methylcellulose + 15 g inulin
• Inulin
15 inulin
• Maltodextrin
15 maltodextrin

Locations

Country	Name	City	State
United Kingdom	Nottingham Digestive Disease Centre	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Quadram Institute Bioscience

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colonic gas volume	AUC 0-6 hours of colonic gas volume	0-6 hours
Secondary	colonic gas volume at 6 hours	MRI assessed colonic gas volume at 6 hours	0-6 hours
Secondary	Breath hydrogen	Area under curve (AUC) from time 0-6 hours of breath hydrogen (ppm.hours)	0-6 hours
Secondary	Oro-cecal transit time		0- 6 hours
Secondary	24 hour breath hydrogen	Area under curve (AUC) from time 0-24 hours of breath hydrogen (ppm.hours)	0-24 hours