Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin

NCT06494137 | Not Yet Recruiting

• 1 other identifier: FMHS 158-0324
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim for this pilot study is to test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.

Conditions

Irritable Bowel Syndrome

Keywords

inulin; fermentation; colon

Outcome Measures

Primary Outcomes (1)

• Breath hydrogen AUC

  Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after consumption of inulin intake.

  0-6 hours

Secondary Outcomes (2)

• Breath hydrogen AUC

  0-24h

• Whole gut transit

  0-7days

Study Arms (3)

Psyllium

ACTIVE COMPARATOR

15g psyllium + 15 inulin dissolved in 250 ml water

Other: inulin

Methylcelulose

ACTIVE COMPARATOR

15g methylcellulose +15 g inulin dissolved in 250 ml water

Other: inulin

Maltodextrin

PLACEBO COMPARATOR

15g maltodextrin +15 g inulin dissolved in 250 ml water

Other: inulin

Interventions

inulin OTHER

inulin from chicory root

Maltodextrin; Methylcelulose; Psyllium

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Quadram Institute Bioscience: collaborator

Study Sites (1)

Nottingham Digestive Disease Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

• Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5.

  PMID: 34353864 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Inulin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Robin C Spiller, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Spiller, MD

CONTACT

07824328319; robin.spiller@nottingham.ac.uk

Joshuah Reid, PhD

CONTACT

07540418235; sbzjer@exmail.nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: gels given in opaque plastic bag
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Model Details: randomised placebo controlled crossover study

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

GB (1)