Effect of Chronic Feeding of Inulin And Methylcellulose on Colonic Fermentation

NCT06551961 | Recruiting

• 1 other identifier: FMHS-199-0524
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Irritable Bowel Syndrome

Keywords

inulin; fermentation; colon; gas

Outcome Measures

Primary Outcomes (1)

• Breath hydrogen 0-6 hours post ingestion

  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 (5)

• Symptoms

  14 days

• Breath hydrogen

  0-24 hours

• Orocaecal transit

  0- 6 hours

• Whole gut transit time

  0-7 days

• Fecal microbiota

  1 and 2 weeks post dosing

Study Arms (2)

methylcellulose

ACTIVE COMPARATOR

2.5 g of Inulin and 2.5g methylcellulose in 62.5 mL water given thrice daily for 7 days increasing to 5 g of Inulin and 5g methylcellulose in 125 mL water on day 8 continuing until day 14

Dietary Supplement: methylcellulose; Dietary Supplement: inulin

Placebo

PLACEBO COMPARATOR

2.5 g of Inulin and 2.5g maltodextrin in 62.5 mL water given thrice daily for 7 days increasing to 5 g of Inulin and 5g maltodextrin in 125 mL water on day 8 continuing until day 14

Dietary Supplement: inulin; Dietary Supplement: maltodextrin

Interventions

methylcellulose DIETARY_SUPPLEMENT

2.5 and 5 gm Methylcelllose heated to create a gel

Also known as: Benecel

methylcellulose

inulin DIETARY_SUPPLEMENT

2.5 and 5 gm inulin powder dissolved in water

Placebo; methylcellulose

maltodextrin DIETARY_SUPPLEMENT

2.5 and 5gm maltodextrin dissolved in water

Also known as: Glusidex

Placebo

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
• University of East Anglia: collaborator

Study Sites (2)

Nottingham Digestive Disease Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Nottingham Digestive Diseases Centre

Nottingham, Please Choose..., NG7 2UH, United Kingdom

RECRUITING

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; Mucopolysaccharidosis IV

Interventions

Methylcellulose; Inulin; maltodextrin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Robin C Spiller, MD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alsion Thorpe, MD

CONTACT

+44 (0)115 7486731; alison.thorpe@nottingham.ac.uk

Sponsor

CONTACT

+44 (0)115 7486731; BB-sponsor@exmail.nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Servings provided in identical pots whose content is only known by one assistant who is not involved in collecting outcomes or analysis of results
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 treatment two period cross-over trial

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: September 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)